Rehabilitation after lumbar disc surgery

Rehabilitation after lumbar disc surgery (Review) Ostelo RWJG, Costa LOP, Maher CG, de Vet HCW, van Tulder MW This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2008, Issue 4 http://www.thecochranelibrary.com Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment, Outcome 1 Pain on VAS (post-treatment). . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.2. Comparison 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment, Outcome 2 Functional status on Modified Oswestry (post-treatment). . . . . . . . . . . . . . . . . . . Analysis 2.1. Comparison 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus lowintensity exercise programs, Outcome 1 Pain (short-term). . . . . . . . . . . . . . . . . . . Analysis 2.2. Comparison 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus lowintensity exercise programs, Outcome 2 Function (short-term). . . . . . . . . . . . . . . . . . Analysis 3.1. Comparison 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises, Outcome 1 Functional status (short-term). . . . . . . . . . . . . . . . . . . . . Analysis 3.2. Comparison 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises, Outcome 2 Pain (short-term). . . . . . . . . . . . . . . . . . . . . . . . . . APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1 1 3 3 4 4 6 8 9 9 10 13 16 16 16 18 34 35 35 36 36 37 37 37 41 42 44 44 44 44 i [Intervention review] Rehabilitation after lumbar disc surgery Raymond WJG Ostelo1 , Leonardo Oliveira Pena Costa2 , Christopher G. Maher2 , Henrica CW de Vet3 , Maurits W van Tulder4 1 EMGO Institute - Institute for Health Sciences, Department of Health Sciences - VU University; VU University Medical Centre, Amsterdam, Netherlands. 2 Musculoskeletal Division - The George Institute of International Health, Faculty of Medicine - The University of Sydney, Sydney, Australia. 3 Department of Epidemiology and Biostatistics, EMGO Institute, Amsterdam, Netherlands. 4 Department of Health Economics & Health Technology Assessment, Institute of Health Sciences, Faculty of Earth & Life Sciences, VU University, Amsterdam, Netherlands Contact address: Raymond WJG Ostelo, EMGO Institute - Institute for Health Sciences, Department of Health Sciences - VU University; VU University Medical Centre, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands. r.ostelo@vumc.nl. (Editorial group: Cochrane Back Group.) Cochrane Database of Systematic Reviews, Issue 4, 2008 (Status in this issue: New search for studies completed, conclusions changed, commented) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD003007.pub2 This version first published online: 8 October 2008 in Issue 4, 2008. Last assessed as up-to-date: 14 November 2007. (Dates and statuses?) This record should be cited as: Ostelo RWJG, Costa LOP, Maher CG, de Vet HCW, van Tulder MW. Rehabilitation after lumbar disc surgery. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003007. DOI: 10.1002/14651858.CD003007.pub2. ABSTRACT Background Several rehabilitation programs are available for individuals after lumbar disc surgery. Objectives To evaluate the effects of active rehabilitation for adults after first-time lumbar disc surgery. Search strategy We searched CENTRAL (The Cochrane Library 2007, Issue 2) and MEDLINE, EMBASE, CINAHL and PsycINFO to May 2007. Selection criteria We only included randomised controlled trials (RCTs). Data collection and analysis Pairs of review authors independently assessed studies for eligibility and risk of bias. A meta-analysis was performed with clinically homogeneous studies. The GRADE approach was used to determine the quality of evidence. Main results Fourteen studies were included, seven of which had a low risk of bias. Most programs were only assessed in one study. Statistical pooling was only completed for three comparisons in which exercises were started four to six weeks post-surgery: exercise programs versus no treatment, high versus low intensity exercise programs, and supervised versus home exercises. There is low quality evidence (three RCTS, N = 156) that exercises are more effective than no treatment for pain at short-term followup (WMD -11.13; 95% CI -18.44 to -3.82) and moderate evidence (two RCTs, N = 136) that they are more effective for functional Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1 status on short-term follow-up (WMD -6.50; 95% CI -9.26 to -3.74). None of the studies reported that exercises increased the reoperation rate. There is low quality evidence (two RCTs, N =103) that high intensity are slightly more effective than low intensity exercise programs for pain in the short term (WMD -10.67; 95% CI -17.04 to -4.30) and moderate evidence (two RCTs, N = 103) that they are more effective for functional status in the short term (SMD -0.77; 95% CI -1.17 to -0.36). There is low quality evidence (three RCTS, N = 95) that there were no significant differences between supervised and home exercises for short-term pain relief (SMD -1.12; 95% CI -2.77 to 0.53) or functional status (three RCTs, N = 88; SMD -1.18; 95% CI -2.63 to 0.26). Authors’ conclusions Exercise programs starting four to six weeks post-surgery seem to lead to a faster decrease in pain and disability than no treatment. High intensity exercise programs seem to lead to a faster decrease in pain and disability than low intensity programs. There were no significant differences between supervised and home exercises for pain relief, disability, or global perceived effect. There is no evidence that active programs increase the re-operation rate after first-time lumbar surgery. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 2 PLAIN LANGUAGE SUMMARY Rehabilitation after lumbar disc surgery A prolapsed lumbar disc (also called a ’slipped’ or ’herniated’ disc) is thought to be the most common cause of sciatica (pain or numbness spreading over the buttocks or legs caused by a ’pinched’ or compressed nerve in the lower back). Many patients are treated effectively by a combination of non-surgical measures such as medication or physiotherapy. However, patients with persistent symptoms often have surgery. While 60% to 90% of patients will improve after surgery, some will continue to have symptoms. It is estimated that 3% to 12% of patients who have disc surgery will develop another prolapsed disc and most of these patients will have surgery again. Active treatment programs, such as physiotherapy, in which the patient is an active participant, and advice to return to normal activities, including work, as soon as possible after surgery are common approaches. This updated review evaluated the effectiveness of various active treatment programs for patients who had lumbar disc surgery for the first time. The review authors included 14 randomised controlled trials with 1927 participants between the ages of 18 and 65 years. Most commonly, treatment started four to six weeks after surgery, but this ranged from two days to 12 months. There was also considerable variation in the content, duration and intensity of the treatments. Most of the treatments were only assessed in one trial and their results are presented in the full review. For programs that started four to six to six weeks after surgery, the review authors were able to pool the results for three comparisons: - Patients who participated in exercise programs reported a slightly less short-term pain and disability than those who received no treatment. - Patients who participated in high intensity programs reported slightly less short-term pain and disability than those in low intensity programs. - Those in supervised exercise programs reported little or no difference in pain and disability than those in home exercise programs. None of the included studies reported that active programs increased the rate of repeated surgery, nor did the evidence suggest that patients should restrict their activities after lumbar disc surgery. However, limitations in the methods of half of the trials suggest the results should be read with caution. The evidence does not tell us whether all patients should be treated after surgery or only those who still have symptoms four to six weeks later. BACKGROUND The lumbosacral radicular syndrome (LRS) is characterized by radiating pain over an area of the buttocks or legs served by one or more lumbosacral nerve roots combined with phenomena associated with nerve root tension or neurological deficit. The prevailing view is that the condition is most commonly caused by a lumbar disc prolapse, however, other pathologies may also cause LRS. It is estimated that there are between 60,000 and 75,000 new cases of LRS in the Netherlands each year (HCN 1999), for which the direct and indirect costs are estimated at 1.6 billion US$ per annum (van Tulder 1995 ). Many patients with LRS are treated conservatively, but surgery is a common option in patients with persistent symptoms. In the Netherlands, with a population of about 16 million people, it is estimated that 10,000 to 11,000 operations are performed each year because of the LRS (HCN 1999 ) but surgery rates vary across countries. An international comparison showed that the rate of back surgery in the United States was at least 40% higher than in any other country and was more than five times those in England and Scotland (Cherkin 1994 ). But even within one country (i.e. the U.S.), considerable regional variations are reported (Weinstein 2006 ). The reported success rate of lumbar disc surgery varies from 60% to 90% (Korres 1992 ; Findlay 1998 ; Loupasis 1999 ; Yorimitsu 2001 ). Differences between these studies with regard to inclusion criteria, indications for surgery and operationalization of success, may account for the wide range in success rate. Still, these figures show that in 10% to 40% of the patients the results of surgery are unsatisfactory and patients still have symptoms. These persisting symptoms mainly consist of pain, motor deficits, a decreased functional status, not being able to return to work, or any combination. In 3% to 12% of patients who undergo disc-surgery for the first time, a recurrent herniated lumbar disc occurs for which almost all patient undergo a re-operation (CBO 2008) Further treatment is often recommended after lumbar disc surgery (e.g. physiotherapy, rehabilitation programs), but there are persistent controversies about many issues. Should all patients receive Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 3 further treatment, or only those patients who still suffer from persisting symptoms after surgery? The necessity and duration of activity restrictions after lumbar disc surgery is still controversial. Although several active rehabilitation programs, physical fitness programs or instruction protocols for patients to return to work after lumbar disc surgery have been suggested, there are still fears that these interventions may cause re-injury, re-herniation, or instability (Manniche 1995; Carragee 1996; Manniche 1996). Unfortunately, little is known about the effectiveness of these treatments. In this updated review, we systematically evaluated the effectiveness of active treatments that are used in rehabilitation after first-time lumbar disc surgery. OBJECTIVES To determine if active rehabilitation after lumbar disc surgery is more effective than no treatment, and to describe which type of active rehabilitation is most effective. First, we clustered treatments according to the start of treatment: 1. Active rehabilitation that starts immediately post-surgery, 2. Active rehabilitation that starts four to six weeks post-surgery, 3. Active rehabilitation that starts more than 12 months postsurgery. Types of interventions Trials with one or more types of active rehabilitation programs aiming at functional restoration (improvement in functional status and return to work) were included. Examples of treatments that were considered are (supervised) exercise therapy, functional restoration programs or rehabilitation-oriented approaches in insurance medicine. Treatments solely aimed at pain relief (e.g. medication) or improvement of physical outcomes such as strength or flexibility were excluded. Types of outcome measures Trials were included if they used at least one of the four primary outcome measures that we considered to be important, that is pain (e.g. VAS), a global measure of improvement (overall improvement, proportion of patients recovered, subjective improvement of symptoms), back-pain specific functional status (e.g. RolandMorris Disability Questionnaire, Oswestry Disability Index), and return-to-work (return-to-work status, days off work). Outcomes of physical examination (e.g. spinal range of motion, straight-leg raise range of motion or muscle strength), behavioural outcomes (e.g. anxiety, depression, pain behaviour) and generic functional status (SF-36, Nottingham Health Profile, Sickness Impact Profile) were considered as secondary outcomes. Other outcomes such as medication use and side-effects were also considered. For every cluster the following comparisons were investigated: Search methods for identification of studies A. Active rehabilitation versus no treatment, placebo or waiting list control, Types of studies All relevant trials meeting our inclusion criteria were identified by: A) A search of CENTRAL (The Cochrane Library 2007, Issue 2), B) A computer aided search of the MEDLINE (from 1966 to May 2007), EMBASE (from 1988 to May 2007), CINAHL (2000 to May 2007) and PsycINFO (from 1984 to May 2007) databases using the search strategy recommended by the Editorial Board of the Cochrane Back Review Group (van Tulder 2003). Specific search terms for low-back pain, lumbar disc surgery and post surgery treatment were added. No language restriction was used. The complete search strategies are outlined in Appendix 1; Appendix 2; Appendix 3; Appendix 4. C) Screening of references given in relevant reviews and identified trials. D) Screening of personal bibliographies and communication with experts in the field. Randomized controlled trials (RCTs) were included and non-randomised controlled trials (CCTs) or quasi RCTs were excluded. Data collection and analysis B. Active rehabilitation versus other kind of active rehabilitation, C. Specific intervention in addition to active rehabilitation versus active rehabilitation alone. METHODS Criteria for considering studies for this review Types of participants Subjects who had first-time lumbar disc surgery because of a lumbar disc prolapse and aged between 18 and 65 years were included. All types of surgical techniques for lumbar disc herniation (e.g. standard discectomy, microdiscectomy, laser discectomy and chemonucleolysis) were included. Study selection Pairs of review authors independently selected the studies to be included in this systematic review by applying the selection criteria to the studies that were retrieved by the literature search. Consensus was used to resolve disagreements concerning selection Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 4 and inclusion of studies and a third review author was consulted if disagreements persisted. Risk of bias assessment The criteria recommended in the updated method guidelines for systematic reviews in the Cochrane Back Review Group were used (van Tulder 2003; Table 1). Pairs of review authors independently assessed the risk of bias of included studies (RO assessed all studies, except the study on which he is the first author; RO was not involved in any decision regarding this trial). We decided not to blind studies for authors, institution or journal because the review authors who assessed the risk of bias were familiar with the literature. A consensus method was used to resolve disagreements and a third review author was consulted if disagreements persisted. If the article did not contain enough information to assess all the risks of bias (i.e. if one or more criteria were scored “unclear”), the review authors contacted the study authors for additional information. The risk of bias assessment form was mailed to all study authors and they were also asked whether they agreed with the risk of bias assessment. Table 1. Criteria for the Risk of Bias Assessment Criteria for a judgment of yes for the sources of risk of bias Adequate method of randomisation: A random (unpredictable) assignment sequence. Examples of adequate methods are computergenerated random numbers table and use of sealed opaque envelopes. Methods of allocation using date of birth, date of admission, hospital numbers, or alternation should not be regarded as appropriate Adequate concealment of randomisation: Assignment generated by an independent person not responsible for determining the eligibility of the patients. This person has no information about the persons included in the trial and has no influence on the assignment sequence or on the decision about eligibility of the patient. Blinding of patients: The review author determines if enough information about the blinding is given in order to score a “yes.” If blinding of patients was not feasible, we assessed this item to be positive if the credibility of applied treatments was evaluated and treatments were equally credible and acceptable to patients Blinding of care providers: The review author determines if enough information about the blinding is given in order to score a “yes.” Blinding of outcome assessment: The review author determines if enough information about the blinding is given in order to score a “yes.” Drop-out during intervention period (<10%) AND withdrawal during follow-up period (<20%): The number of participants who were included in the study but did not complete the observation period or were not included in the analysis must be described and reasons given. If the percentage of drop-outs during the intervention period does not exceed 10% AND withdrawal during follow-up does not exceed 20% and does not lead to substantial bias, a “yes” is scored. Intention-to-treat analysis: All randomized patients are reported/analyzed in the group to which they were allocated by randomization for the most important moments of effect measurement (minus missing values), irrespective of noncompliance and co-interventions. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 5 Table 1. Criteria for the Risk of Bias Assessment (Continued ) Similarity of baseline characteristics: In order to receive a “yes,” groups have to be similar at baseline regarding demographic factors, Co-interventions avoided or equal: Co-interventions should either be avoided in the trial design or be similar between the index and control groups. Compliance: The review author determines if the compliance to the interventions is acceptable, based on the reported intensity, duration, number and frequency of sessions for both the index intervention and control intervention(s). Identical timing outcome assessment: Timing of outcome assessment should be identical for all intervention groups and for all important outcome assessments. Description of studies Data extraction Pairs of review authors independently extracted data from the studies using a standardized form (RO extracted data from all studies, except from the study on which he is the first author). All pairs of review authors who extracted the data, first piloted the data extraction form by using two RCTs on back pain without surgery. The domains that were assessed for data extraction were characteristics of patients and interventions, and results on primary and secondary outcome measures. Data analysis and the GRADE approach If studies were clinically homogeneous regarding study population, types of treatment and reference treatments, and outcomes and measurement instruments, a meta-analysis was performed. If possible, we calculated the weighted mean difference (WMD) because this improves the interpretability of the results. If a WMD was not possible the standardised mean difference (SMD) was calculated. For the comparisons where studies were too heterogeneous, no meta analysis was performed. The Editorial Board of the Cochrane Back Review Group recommends presenting the overall quality of the evidence using the GRADE approach. The quality of the evidence on a specific outcome is based on the study design, the potential for bias, consistency of results, directness (generalizability), precision (sufficient data) and potential reporting bias for the results across all studies that measure that particular outcome. The overall quality is considered to be high when RCTs with a low risk of bias provide consistent, generalizable results for the outcome, and reduces by one level when one of the factors described above are not met (Furlan 2008 ). In the case of only one study measuring an outcome, we considered the data to be ’sparse’ and subsequently labelled the evidence as ’low quality evidence’. To improve the readability of this review, a GRADE table was only completed when we completed a meta analysis. If only one study was present for a given comparison, the results are described in the text and in the Characteristics of included studies table. See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies. In total, 14 studies were included in this updated systematic review. Two RCTs assessed the effectiveness of programs that started immediately after surgery: one RCT focused on neural mobilization (Scrimshaw 2001), and one RCT assessed the effectiveness of intensive exercises (Kjellby-Wendt 1998 ). The majority of trials focused on treatments that started four to six weeks post-surgery. Two trials (Yilmaz 2003 ; Filiz 2005 ) included three arms, one of which was a no treatment arm, yielding two comparisons per RCT. For three comparisons assessing the effectiveness of interventions starting four to six weeks post surgery, a meta-analysis could be performed: exercise program versus no treatment (comparison 2A); high intensity programs versus low intensity programs (comparison 2B.1); and supervised exercise program versus home exercises (comparison 2B.2). For all other types of interventions (or programs) that started four to six weeks post surgery, there was only one study per comparison. Finally, two studies assessed treatment regimens that started later than 12 months after the surgery. Risk of bias in included studies The risk of bias of the included studies was assessed by using the criteria recommended in the updated method guidelines by the Cochrane Back Review Group (van Tulder 2003). If blinding of patients was not feasible, we redefined the item: the item assessing the blinding of patients was scored positive if the credibility of applied treatments was evaluated and treatments were equally credible and acceptable to patients (see Table 1 for criteria). Each criterion was assessed as “positive”, “negative” or “unclear”. Studies with a low risk of bias were defined as RCTs that fulfilled five or more of the risk of bias criteria. Effects of interventions Study selection RESULTS The search for the original review (until 2000) yielded 427 studies in MEDLINE, 414 in EMBASE and 135 in The Cochrane li- Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 6 brary. The first selection of this part of the search was based on keywords, title and abstract, resulting in the inclusion of 11 RCTs and 4 CCTs. After reading of the full text papers, two studies were excluded because one study evaluated intraoperative epidural corticosteroids (Lavyne 1992) and one evaluated the use of parenteral Ketorolac during wound closure (Le Roux 1999). Neither intervention matched our definition of active rehabilitation, yielding a total of nine RCTS and four CCTs for the original review. For this update, we searched the same databases plus CINAHL from 2000 until June 2007, but in line with the updated guidelines, only RCTs were included, yielding a total of 3059 hits. The first selection, based on title and abstract, resulted in 10 papers: five new RCTs, one long-term follow-up of an already included RCT (Kjellby-Wendt 1998 ) and one published protocol (Selkowitz 2006 ). Reference checking yielded another long-term follow-up of an already included RCT (Kjellby-Wendt 1998). After reading the full text papers, one RCT was excluded because this study was not an effectiveness study (Woischnek 2000 ). Four studies that were included in the original review were excluded because they were not randomised (Brennan 1994; Burke 1994; Kitteringham 1996; Rotthaupt 1997). Therefore, this updated systematic review includes a total of 14 randomised trials. Risk of bias in included studies Fifty percent of the included studies (seven out of 14) were assessed to have a low risk of bias. Care providers could not be blinded due to the nature of the interventions. Because blinding of patients is also often hampered (for similar reasons) we redefined this item (see method section). In addition, the credibility or acceptability of applied treatments was not evaluated in any study. In six studies, the randomisation (method AND concealment) was not described adequately and in eight studies, the compliance to the rehabilitation program was inadequate or not assessed. There was a general lack of published details concerning co-interventions: only two studies explicitly provided information on co-interventions. These methodological shortcomings in the conduct and reporting of studies suggest considerable potential for bias in half of the included trials (see Figure 1 for results of individual trials). Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 7 Figure 1. Summary of risks of bias Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 8 For overall judgement of quality of evidence, see GRADE tables (Figure 2; Figure 3; Figure 4). Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 9 Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 10 Effectiveness of rehabilitation programs return-to-work between an intensive exercise program and a less active program. 1. Comparisons among rehabilitation programs that start immediately after surgery. 1 C. Specific intervention in addition to a treatment program versus treatment alone 1 A. Treatment versus no treatment, placebo or waiting list control No trials were identified. 1 B. Treatment versus other kinds of treatment One small (N = 60) RCT with a high risk of bias (Kjellby-Wendt 1998 ) compared an intensive exercise program consisting of increasing daily activities, home training (mobilisation, trunk strengthening) and later mainly intensive muscle strengthening exercises and cardiovascular exercises with a control group that received no increasing daily activities, exercises only once a day and no promotion of cardiovascular exercises. The results showed that there were no statistically significant differences for pain, global perceived effect and sick leave outcomes. Only secondary analyses (leg pain on a VAS in a subgroup of patients with sciatica, and some clinical outcome measures) showed some small differences in favour of the intensive exercise program. However, these were post-hoc analyses that do not allow firm conclusions. At the five to seven-year follow-up, there were no relevant differences in the number of patients that had leg pain (VAS) or back pain (VAS), or days of sick leave. There was one re-operation (3.4%) in the intervention group and two re-operations (6.5%) in the reference group. There is a low quality evidence illustrating that there is no difference in the long-term for global perceived effect, pain or One small RCT with a low risk of bias (Scrimshaw 2001 ) (N = 59) evaluated the effectiveness of adding neural mobilisation to standard postoperative care consisting of isometric and dynamic exercises (progress as tolerated). The aim of the neural mobilisation was to maintain interplane mobility of the neural structures by stimulating gliding surfaces, and consisted mainly of repeated through-range straight leg raises. The published RCT reports on 81 patients, but only 59 patients received a standard laminectomy while the others underwent a fusion. For this review, we only analysed the 59 laminectomy patients (unpublished data). There is low quality evidence from one RCT (N = 59) that neural mobilisation is not effective as an adjunct to standard postoperative care on pain (mean difference - 6.8; 95% CI - 22.2 to 8.6 on a 0-100 VAS) and functional status (mean difference 4.5; 95% CI -7.2 to 16.2 on 0-100 Quebec Disability Scale) after six weeks follow-up. For these outcome measures, as well as for overall improvement, there were also no differences after 12 months. No data were presented on re-operation rates. 2. Comparisons among rehabilitation programs that start 4-6 weeks post surgery. 2 A. Exercise programs versus no treatment One very small (N = 20) RCT with a low risk of bias (Dolan 2000) and two small (total N = 102) RCTs with a high risk of bias Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 11 (Yilmaz 2003; Filiz 2005) compared an exercise program with no treatment. Both Filiz 2005 and Yilmaz 2003 were three-armed RCTs with one no-treatment arm and two exercise arms, yielding two comparisons for each study. Outcome was only measured at the post-treatment follow-up. For treatments that start four to six weeks post-surgery, there is low quality evidence (three RCTs with five comparisons, N = 156) that exercise programs are more effective than no treatment on short-term follow-up for pain (WMD -11.13; 95% CI -18.44 to -3.82 on a 0-100 VAS), and moderate quality evidence (two RCTs with four comparisons, N = 136) in favour of exercise programs for functional status on short-term follow-up (WMD -6.50; 95% CI -9.26 to -3.74 on the 0 to50 Modified Oswestry). None of the included studies reported that these active programs increased the re-operative rate. 2 B. Treatment versus other kinds of treatment 2 B.1 High intensity exercise programs versus low intensity exercise programs Two RCTs with a low risk of bias (total N = 159) (Manniche 1993a; Danielsen 2000) and one small (N = 42) RCT with a high risk of bias (Yilmaz 2003) compared intensive exercise programs with mild exercise programs. There are sparse data reporting no statistically significant differences on overall improvement at shortterm follow-up (Manniche 1993a) and at six and 12-month followup (Danielsen 2000). There is low quality evidence (two RCTs, N = 103) that high intensity exercise programs are slightly more effective for pain in the short term compared to low intensity exercise programs (WMD 10.67; 95% CI -17.04 to -4.30 on a 0-100 VAS), and moderate quality evidence (two RCTs, N = 103) in favour of high intensity exercise programs compared to low intensity exercise programs for functional status in the short term (SMD -0.77; 95% CI -1.17 to -0.36). Long-term follow-up results for both pain and functional status were contradictory. Results for sick leave, which could not be pooled, were also contradictory: Danielsen 2000 reported no significant differences in sick leave during the one-year follow-up (high intensity: mean 18.5 weeks (SD 14.3) versus 22.0 weeks (SD 18.6) for low intensity, while Filiz 2005 reported that patients in the high intensity programs returned to work quicker (mean after 56 days, SD 18.6) as compared to the low intensity program (mean after 75 days, SD 24.9). Danielsen 2000 reported one-year re-operative rates that were negligible. 2 B. 2 Supervised exercise program versus home exercises Three small (total N = 142) RCTs with a high risk of bias (Johannsen 1994; Yilmaz 2003; Filiz 2005) compared supervised exercise programs to home exercise programs. There are sparse data from one trial (Johannsen 1994) showing no differences on global perceived effect (four-point scale) at both the post-treatment and the three-month follow-up. There is low quality evidence (three RCTs, N = 95) that there were no significant differences between supervised exercise program and home exercises on short-term pain relief (pooled SMD -1.12; 95% CI -2.77 to 0.53). There are sparse data from one trial (Johannsen 1994) that there were no differences between groups on long-term pain relief. For functional status, there is low quality evidence (three RCTs, N = 88) that there were no short-term differences between supervised exercise programs and home exercises (pooled SMD -1.18; 95% CI -2.63 to 0.26). For the long term, there are only sparse data (Johannsen 1994 ) reporting no significant differences between groups. One small (N = 40) trial (Johannsen 1994) reported re-operative rates that were negligible in both groups. 2 B. 3 Multidisciplinary rehabilitation program Only one RCT with a high risk of bias (N = 212) (Alaranta 1986) compared a multidisciplinary rehabilitation program that consisted of sessions with a physical therapist, psychiatrist, occupational therapist, psychologist, social worker and an intensive back school with usual care. There is low quality evidence that at oneyear follow-up, there were no statistically significant differences between groups for global perceived effect, sick leave or re-operative rates (3.7% in both groups). 2 B. 4 Rehabilitation in the occupational setting One large (N = 710) RCT with a low risk of bias (Donceel 1999) compared a multidisciplinary rehabilitation-oriented approach intervention, coordinated by medical advisers of a social security sickness fund for a patient population with mandatory insurance, with usual care. Because there was only one RCT, there is low quality evidence that suggests that a rehabilitation-oriented approach by the medical advisers of social security is more effective than usual care on return-to-work at long-term follow-up. 2 B. 5 Behavioural treatment One RCT with a low risk of bias (N = 105) compared a behavioural graded activity program with standard physiotherapy (Ostelo 2003 ). There was low quality evidence (one RCT only) that in the short term there was a clinically relevant and statistically significant difference of 19% in global perceived recovery in favour of the physiotherapy program, but there were no differences on the long term. There was also low quality evidence that there were no differences (short-term or long-term) in pain (VAS), functional status (RDQ) or return-to-work. This trial also included a cost effectiveness analysis that suggested that the behavioural program was associated with higher costs during the one-year follow-up. 2 B. 6 Stretching and strength training One RCT with a high risk of bias (Hakkinen 2005) included 126 patients, two months after their first lumbar disc surgery if they were not pain free (VAS >10 mm). The intervention group received a 12-month home exercise program after one instruction session. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 12 Patients were instructed to stretch and perform stabilization exercises and to perform strength training (instructed to perform two series of exercises twice a week). The control group received identical instructions, except for the strength training. There is low quality evidence that after 12 months there were no clinically relevant or statistically significant differences in pain (VAS) and disability (ODI). 2 C Specific intervention in addition to a treatment program versus treatment alone No RCTs were identified. 3. Comparisons among rehabilitation programs that start more than 12 months post surgery. 3 A. Treatment versus no treatment, placebo or waiting list control No RCTs were identified. 3 B. Treatment versus other kinds of treatment One RCT with a high risk of bias (Timm 1994) compared physical agents with joint manipulations, high-tech exercise, low-tech exercise and no treatment in 250 workers after first-time surgery. There is low quality evidence that low-tech and high-tech exercise might be more effective in improving low-back functional status as compared to physical agents, joint manipulations or no treatment. 3 C. Specific intervention in addition to a treatment program versus treatment alone One small (N = 62) RCT with a low risk of bias (Manniche 1993b) added hyperextension to an intensive exercise program. On shortterm measurement, there was a statistically significant improvement in functional status, which was no longer present at longterm follow-up. There were no re-operations. There is low quality evidence that adding hyperextension to an intensive exercise program might not be more effective than intensive exercise alone on overall improvement or functional status outcomes. DISCUSSION Fourteen RCTs were included in this systematic review. The studies were heterogeneous with regard to timing, ranging from starting two days post-surgery up to more than 12 months postsurgery. The duration and intensity of the interventions also differed widely. Due to this clinical heterogeneity, statistical pooling of the results was considered appropriate in only three comparisons: exercise program versus no treatment (comparison 2A); high intensity programs versus low intensity programs (comparison 2B.1); and supervised exercise program versus home exercises (comparison 2B.2). The effectiveness of many different rehabilitation programs has been assessed, but the majority in only one study. The results showed that adding neural mobilization to an exercise program was not effective for pain and functional disability in the shortand long-term. For treatments that started four to six weeks postsurgery, the pooled results suggest that exercise programs lead to a faster decrease in pain as compared to no treatment, and that high intensity programs, also starting four to six weeks post surgery, lead to a faster decrease in pain than low intensity programs. But these results should be interpreted cautiously as these are only supported by low quality evidence. However, the observation that exercise programs lead to a faster decrease in disability as compared to no treatment, and that high intensity programs, lead to a faster decrease in disability than low intensity programs is supported by moderate quality evidence. Mainly due to sparse data, the results with regard to long-term follow-up could not be pooled. None of the included studies reported that these active programs increase the re-operative rate. Because of these negligible rates, we concluded that it is not harmful to return to activity after lumbar disc surgery and consequently, that it is not necessary for patients to stay passive after lumbar disc surgery. This is in line with Carragee 1996 , who concluded that lifting postoperative restrictions after limited discectomy led to shortened sick leave without increased complications. Based on pooled results, we found some evidence suggesting that supervised training is not more effective than home-based training in the short-term. But again, these results should be interpreted cautiously (only low quality evidence). Moreover, the compliance, both of the home exercise programs and the supervised programs, is poorly reported in these studies, further hampering an adequate interpretation. Hakkinen 2005 assessed the adherence rates to home exercise programs that lasted 12 months. It was demonstrated that after two months, the adherence rates dropped to 50% to 60% of the target, dropping further to only 30% in the last six months. This seems to suggest that more intensive supervision needs to be in place for long-term rehabilitation, to maintain patients’ motivation. One RCT with a low risk of bias (Donceel 1999) assessed an intervention of medical advisers of a social security sickness fund on a patient population with mandatory insurance. These medical advisors coordinated a multidisciplinary rehabilitation-oriented approach. The results of this study indicate that an intervention aimed at an active rehabilitation policy, encompassing gradual work resumption, information, early mobilization, and early contact with the medical adviser increased the probability of return-to-work for these patients. Although this is only one RCT in a specific setting (approaches like this are highly dependent on the social security system), these results look promising. The results are in agreement with the fact that patients Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 13 In this systematic review, all surgical techniques were included a priori. Patients included in the studies had all received standard discectomy or microdiscectomy. A recent systematic Cochrane review showed that there were no significant differences in effectiveness between these two approaches (Gibson 2007a ; Gibson 2007b). Therefore, it is unlikely that different surgical techniques have biased the results of this systematic review. Another important issue regarding surgery needs to be discussed. Although it was not the main focus of the current systematic review, it is important to know the indication for surgery, because indications might change over time, with potential consequences for rehabilitation. Unfortunately, the description of the indication for surgery in the included studies is scarce. In four RCTs (out of the 14), no description of the indication was given at all (only that there had been a surgery) and in seven RCTs, the only description was that patients were operated on because of a lumbar disc prolapse, without further information. In only three RCTs was it stated that the signs and neuromuscular symptoms and dysfunction should be elicited by a lumbar disc prolapse (or herniation) confirmed by an imaging technique. Future studies on rehabilitation should include more details on this issue in their design (see Table 2 for clinical relevance criteria, Table 3 for assessment results). do not need to have their activities restricted and that aiming at an early re-activation is an effective approach (Carragee 1996 ). Furthermore this study highlights the need for more than just exercising if an intervention aims at early return to work. Further research is needed to assess whether these types of interventions are (cost-) effective. Regarding bio-psychosocial aspects of post-surgery rehabilitation, it has been suggested that high-intensity programs confront patients with their fears and insecurities and that they learn that symptoms related to training are not necessarily dangerous (Manniche 1993b ). In this updated review we included a RCT with a low risk of bias that assessed the effectiveness of a behavioural graded activity (BGA) program, that focused on bio-psychosocial aspects (Ostelo 2003). The results of this study indicate that there were no differences between the BGA program and standard physiotherapy. As of yet, there seems to be no convincing evidence to use bio-psychosocial-oriented approaches in the rehabilitation of patients after first-time disc surgery. Despite that, it could be hypothesized that, as both treatment arms in this RCT were active treatment programs, the results of this RCT also show that active programs do not increase the re-operative rate or that patients need to have their activities restricted after their first lumbar surgery. Table 2. Clinical relevance assessment questions Based on the data provided, can you determine if the results will be clinically relevant? 1. Are the patients described in detail so that you can decide whether they are comparable to those that you see in your practice? 2. Are the interventions and treatment settings described well enough so that you can provide the same for your patients? 3. Were all clinically relevant outcomes measured and reported? 4. Is the size of the effect clinically important? 5. Are the likely treatment benefits worth the potential harms? Table 3. Results of clinical relevance assessment Study Patients Interventions Relevant outcomes Size of effect Benefit & Harms Alaranta 1986 N N Y N N Danielsen 2000 Y Y Y Y Y Dolan 2000 Y Y Y Y Donceel 1999 Y Y Filiz 2005 Y Y Y Y Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. N N 14 Table 3. Results of clinical relevance assessment (Continued ) Hakinnen 2005 N Y Y N N Johanssen 1994 Y Y Y N N Kjellby-Wendt 1998 Y Y Y N N Manniche 1993a Y Y Y Manniche 1993b Y Y Y Ostelo 2003 Y Y Y N N Scrimshaw 2001 Y Y Y N N Timm 1994 Y Y N Yilmaz 2003 Y N Y This updated review differs in some aspects from the original review. In this update, only RCTs were included and in total five new studies were included. Therefore, it was now possible to pool the data in three comparisons. In addition, we used the GRADE approach in this update, as recommended by the Editorial Board of the Cochrane Back Review Group (CBRG), while in the original review the ’levels of evidence’ approach was used. The GRADE approach gives an overall grade of the quality of the evidence, in which the study design, risk of bias, consistency of results, directness (to the population in question), and the precision of results across all studies that measure that particular outcome are taken into account. Pooling the data and applying the GRADE approach slightly changed the underpinning quality of evidence of the results compared to the original review. In the original review, based on the ’levels of evidence’ we concluded that for treatments that start four to six weeks post-surgery there is strong evidence (level one) that high intensity programs are more effective on functional status. In this updated review this is underpinned with moderate grade of evidence. This change in strength of the evidence may seem somewhat inconsistent. But in our original review we clearly stated that although it was concluded, based on the ’levels of evidence’ that the evidence was ’strong’, this conclusion was based on only two studies with a low risk of bias. If results depend greatly on the system of summarizing the evidence, this means that the conclusions cannot be interpreted as absolutely convincing. An important topic for future research is the identification of relevant subgroups. The goal of lumbar disc surgery is to relieve the leg pain of patients. Kjellby-Wendt 1998 presented a positive outcome for a subgroup with residual leg pain in favour of early active training. But numbers were too small and no firm conclusion Y could be drawn. This raises the question whether patients with residual leg pain should be treated differently than patients without residual leg pain. Another important topic for future trails relates to return-to-work or sick leave. Although various trials measured return-to-work or sick leave, the results of the current review should be interpreted with caution, with the exception of Donceel, because this study was specifically set up in an occupational setting to improve return-to-work. One difficulty when interpreting the return-to-work (or sick leave) results is that it is often unclear how many patients were employed (or not) at baseline and if that was comparable between groups. A second difficulty relates to the method of measuring return-to-work (or sick leave), which was rarely described. Future RCTs should include appropriate measures of return-to-work. Maybe even more importantly, full economic evaluations should be performed alongside these trials to assess the cost-effectiveness and cost-utility of rehabilitation programs following lumbar disc surgery. Although we conclude that it is not harmful to return to activity after lumbar disc surgery and therefore it is not necessary for patients to stay passive after lumbar disc surgery, it is still unclear what exact components should be included in rehabilitation programs. High intensity programs seem to be more effective but they could also be more expensive. Therefore cost-effectiveness analysis should be performed in order to assess whether intensive rehabilitation programs, if started early after surgery, lead to a reduction in costs in terms of less healthcare utilization or earlier return to work. Future research should also focus on the implementation of rehabilitation programs in daily practice. Should all patients be treated post-surgery or is a minimal intervention with the message “return to an active lifestyle” sufficient, with only patients that still have symptoms four to six weeks post-surgery requiring reha- Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 15 bilitation programs? The cost-effectiveness of this approach needs to be investigated. In conclusion, more research is needed on the (cost-) effectiveness of rehabilitation after first-time disc surgery. AUTHORS’ CONCLUSIONS Implications for practice Exercise programs starting four to six weeks post-surgery seem to lead to a faster decrease in pain and functional disability when compared to no treatment, and high intensity programs lead to a faster decrease in pain and functional disability than low intensity programs. There is no evidence that these active programs increase the re-operation rate or that patients need to have their activities restricted after first-time lumbar surgery. Implications for research Future research should focus on determining the exact content of treatment programs and how they should be implemented in daily practice. Should all patients be treated post surgery or is a minimal intervention with the message “return to an active lifestyle” sufficient, and do only patients that still have symptoms four to six weeks post-surgery need to participate in rehabilitation programs? Future research should also focus on the identification of relevant subgroups and the role of psychosocial factors. ACKNOWLEDGEMENTS We would like to thank Vicki Pennick, Heather Widdrington, Rachel Couban and Marie-Andree Nowlan of the Cochrane Back Review Group for their support. We would also like to thank Maria Kerckhoffs, Pieter Leffers and Gordon Waddell for their contributions to the original review and Claus Manniche for his critical appraisal of the original review. REFERENCES References to studies included in this review Dolan 2000 {published data only} Dolan P, Greenfield K, Nelson RJ, Nelson IW. Can exercise therapy improve the outcome of microdiscectomy?. Spine 2000;25:1523–32. Alaranta 1986 {published data only} Alaranta H, Hurme M, Einola S, Kallio V, Knuts LR, Torma T. Rehabilitation after surgery for lumbar disc herniation: results of a randomized clinical trial. International journal of rehabilitation research 1986;9(3):247–57. Donceel 1999 {published data only} Donceel P, Du Bois M, Lahaye D. Return to work after surgery for lumbar disc herniation. A rehabilitation-oriented approach in insurance medicine. Spine 1999;24(9):872–6. Danielsen 2000 {published data only} Danielsen JM, Johnsen R, Kibsgaard SK, Hellevik E. Early aggressive exercise for postoperative rehabilitation after discectomy. Spine 2000; 25(8):1015–20. Filiz 2005 {published data only} Filiz M, Cakmak A, Ozcan E. The effectiveness of exercise programmes after lumbar disc surgery. Clinical Rehabilitation 2005;19: 4–11. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 16 Filiz 2005 (1) {published data only} see Filiz 2005. Hakkinen 2005 {published data only} Hakkinen A, Ylinen J, Kautiainen H, et al.Effects of home strength training and stretching program versus stretching alone after lumbar disk surgery. Archives of Physical Medicine and Rehabilitation 2005; 86:865–70. Johannsen 1994 {published data only} Johannsen F, Remvig L, Kryger P, Beck P, Larsen LH, Warming S, Dreyer V. Supervised endurance exercise training compared to home training after first lumbar diskectomy: a clinical trial. Clinical and experimental rheumatology 1994;12(6):609–614. Kjellby-Wendt 1998 {published data only} Kjellby-Wendt G, Carlsson S, Styf J. Results of early active rehabilitation 5-7 years after surgical treatment for lumbar disc herniation. J Spin Dis Tech 2002;15:404–409. Kjellby Wendt G, Styf J. Early active training after lumbar discectomy. A prospective, randomized, and controlled study. Spine 1999; 23(21):2345–51. ∗ Kjellby-Wendt G, Styf J, Carlsson S. Early active rehabilitation after surgery for lumbar disc herniation. acta Orthop Scan 2001;72:518– 24. Manniche 1993a {published data only} Manniche C, Skall HF, Braendholt L, Christinsen BH, Christophersen L, Ellegaard B, Heilbuth A, Ingerslev M, Jorgensen OE, Larsen E, Lorentzen L, Nielsen, CJ, Nielsen H, Windelin M. Clinical trial of postoperative dynamic back exercises after first lumbar discectomy. Spine 1993;18(1):92–7. Manniche 1993b {published data only} Manniche C, Asmussen K, Lauritsen B, Vinterberg H, Karbo H, Abildstrup S, Fischer-Nielsen K, Krebs R, Ibsen K. Intensive dynamic back exercises with or without hyperextension in chronic back pain after surgery for lumbar disc protrusion. A clinical trial. Spine 1993; 18(5):560–7. Ostelo 2003 {published data only} Ostelo RW, de Vet HC, Berfelo MW, Kerckhoffs MR, Vlaeyen JW, Wolters PM, van den Brandt PA. Effectiveness of behavioral graded activity after first-time lumbar disc surgery: short term results of a randomized controlled trial. European Spine Journal 2003;12(6): 637–44. Ostelo RW, de Vet HC, Vlaeyen JW, Kerckhoffs MR, Berfelo WM, Wolters PM, et al.Behavioral graded activity following first-time lumbar disc surgery: 1-year results of a randomized clinical trial. Spine 2003;28(16):1757–65. Ostelo RW, Goossens ME, de Vet HC, van den Brandt PA. Economic evaluation of a behavioral-graded activity program compared to physical therapy for patients following lumbar disc surgery. Spine 2004;29(6):615–22. Scrimshaw 2001 {published and unpublished data} Scrimshaw S, Maher C. Randomized controlled trial of neural mobilization after spinal surgery. Spine 2001;26:2647–52. Scrimshaw S, Maher C. Randomized controlled trial of neural mobilization after spinal surgery. Unpublished data. Timm 1994 {published data only} Timm KE. A randomized-control study of active and passive treatments for chronic low back pain following L5 laminectomy. The Journal of Orthopaedic and Sports Physical Therapy 1994;20(6):276–86. Yilmaz 2003 {published data only} Yilmaz F, Yilmaz A, Merdol F, Parlar D, Sahin, F, Kuran B. Efficacy of dynamic lumbar stabilization exercise in lumbar microdiscectomy. Journal of Rehabilitation Medicine 2003;35:163–7. Yilmaz 2003 (1) {published data only} see Yilmaz 2003. References to studies excluded from this review Brennan 1994 {published data only} Brennan GP, Shultz BB, Hood RS, Zahniser JC, Johnson SC, Gerber AH. The effects of aerobic exercise after lumbar microdiscectomy. Spine 1994;19(7):735–9. Burke 1994 {published data only} Burke SA, Harms Constas CK, Aden PS. Return to work/work retention outcomes of a functional restoration program. A multi-center, prospective study with a comparison group. Spine 1994;19(17): 1880–5. Kitteringham 1996 {published data only} Kitteringham C. The effect of straight leg raise exercises after lumbar decompression surgery - A pilot study. Physiotherapy 1996;82(2): 115–23. Lavyne 1992 {published data only} Lavyne MH, Bilsky MH. Epidural steroids, postoperative morbidity, and recovery in patients undergoing microsurgical lumbar discectomy. Journal of Neurosurgery 1992;77(1):90–5. Le Roux 1999 {published data only} Le Roux PD, Samudrala S. Postoperative pain after lumbar disc surgery: a comparison between parenteral ketorolac and narcotics. Acta neurochirurgica 1999;141(3):261–7. Rotthaupt 1997 {published data only} Rothaupt D, Laser T, Ziegler H, Liebig K. [Die Orthopädische Hippotherapie in der postoperativen Rehabilitation von lumbalen Bandschiebenpatienten. Eine prospektive, randomisierte Therapiestudie]. Sportverletz Sportschaden 1997;11:63–9. Woischnek 2000 {published data only} Woisschnek D, Hussein S, Ruckert N, Heissler H. Criteria for the initiation of rehabilitation after lumbar disc surgery: pilot study. Rehabilitation 2000;39:88–92. References to ongoing studies Selkowitz 2006 {published data only} The immediate and long-term effects of exercise and patient education on physical, functional, and quality-of-life outcome measures after single-level lumbar microdiscectomy: a randomised controlled trial protocol.. Ongoing study Starting date of trial not provided. Contact author for more information. Additional references Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 17 Carragee 1996 Carragee EJ, Helms E, O’Sullivan G. Are postoperative activity restrictions necessary after posterior lumbar discectomy. Spine 1996; 21:1893–7. CBO 2008 The Dutch Institute for Healthcare Improvement (CBO). The lumbosacral radicular syndrome. Report 2008 (in press). Cherkin 1994 Cherkin DC, Deyo R, Loeser JD, et al.An international comparison of back surgery rates. Spine 1994;11:1201–6. Findlay 1998 Findlay GF, Hall BI, Musa BS, Oliveria MD, Fear SC. A 10-year follow-up of the outcome of lumbar microdiscectomy. Spine 1998; 23:1168–71. Furlan 2008 Furlan AD, Pennick V, Bombardier C, van Tulder MW, on behalf of the Editorial Board of the Cochrane Back Review Group. Updated method guidelines for systematic reviews in the Cochrane Back Review Group. Cochrane Back Review Group Editorial Board 2008. Gibson 2007a Gibson JNA, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD001350.pub4] Gibson 2007b Gibson AJN, Waddell G. Surgical interventions for lumbar disc prolapse. Updated Cochrane review. Spine 2007;32(16):1735–47. HCN 1999 Health Council of the Netherlands. Management of the lumbosacral radicular syndrome (sciatica). The Hague: Health Council of the Netherlands. Publication no. 1999/18 1999. Korres 1992 Korres DS, Loupassis G, Stamos K. Results of lumbar discectomy: a study using 15 different evaluation methods. European Spine Journal 1992;1:20–4. Loupasis 1999 Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine 1999;24:2313–7. Manniche 1995 Manniche C. Assessment and exercise in low back pain: With special reference to the management of pain and disability following firsttime disc surgery. Danish Medical Bulletin 1995;42:301–13. Manniche 1996 Manniche C. Clinical benefit of intensive dynamic exercises for low back pain. Scandinavian Journal of Medicine & Science in Sports 1996; 6:82–7. van Tulder 1995 van Tulder MW, Koes BW, Bouter LM. A cost-of-illness study of back pain in the Netherlands. Pain 1995;12:632–44. van Tulder 2003 van Tulder M, Furlan A, Bombardier C, Bouter L, Editorial Board of the Cochrane Collaboration Back Review Group. Updated Method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group for Spinal Disorders. Spine 2003;28:1290–9. Weinstein 2006 Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States’ trends and regional variations in lumbar spine surgery: 19922003. Spine 2006;31:2707–14. Yorimitsu 2001 Yorimitsu E, Chiba K, Toyama Y, et al.Long term outcomes of standard discectomy for Lumbar Disc Herniation. Spine 2001;26:652–8. References to other published versions of this review Ostelo 2003a Ostelo RWJG, de Vet HCW, Waddell G, Kerckhoffs MR, Leffers P, van Tulder MW. Rehabilitation after lumbar disc surgery. Spine 2003;28(3):209–18. Ostelo 2004 Ostelo RW, de Vet HC, Waddell G, Kerckhoffs MR, Leffers P, van Tulder MW. Rehabilitation after lumbar disc surgery. Cochrane Database of Systematic Reviews 2002, Issue 2. [DOI: 10.1002/14651858.CD003007] ∗ Indicates the major publication for the study CHARACTERISTICS OF STUDIES Characteristics of included studies [ordered by study ID] Alaranta 1986 Methods Patients were randomised with stratification on sex and age (above 40 years) before the operation Participants 212 patients after first time disc surgery because of lumbar prolapse: operation that was Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 18 Alaranta 1986 (Continued ) usually carried out through an interlaminar trepanation and besides sequester all loose nucleus pulposus was removed Interventions Immediate postoperative care same in both groups: out of bed day after surgery, two onehour health education lessons. (I) start four weeks after surgery (N = 106): multifactorial rehabilitation (physiatrist, physical and occupational therapist, psychologist, social worker) for two weeks, “Intensive Back School”. Encouraging physical activities. (R) normal care: not described Outcomes All numbers:one year follow-up.Global perceived effect (five point scale) ”Much better“ or ”Better: (I) 88%, (R) 83% not statically significant (NB: includes surgery!) Occupational handicap (WHO scales) and total sick leave during one year follow-up period no significant differences between groups. Re-operations: (I) 4/106, (R) 4/106: No difference Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear Unclear from text Allocation concealment? Unclear B - Unclear Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Yes Incomplete outcome data addressed? Unclear Unclear from text Similarity of baseline characteristics? Unclear Unclear from text Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Danielsen 2000 Methods Randomization “by random number table” Participants 63 patients aged 22-58 (range), four weeks after operation for lumbar disc herniation (arcotomy in 36 patients, microsurgical in 27 patients, N = 3 at L3-L4, N = 34 at L4-L5, N=24 L5-S1)) Interventions (I) Rehabilitation program (N = 39): From week four to 12, three times per week (40 minutes a session) exercise therapy; exclusively active, no manual intervention or physical therapist, Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 19 Danielsen 2000 (Continued ) strengthen muscles (various apparatus) patient tailored. (R) (N = 24) week one through three: standard program, then follow-up consultation (info about clinical course and clinical examination) with physical therapist every two weeks for eight weeks, formula with mild home-exercise program, relaxing and resting the back and resume daily activities gradually, avoid any kind of heavy work at home Outcomes Pain intensity (VAS) absolute values (abs.) and mean improvement (MI), (95%CI) at six months (I) abs. 2.3 (1.5-3.1) (MI) 3.7 (2.7-4.7), (R) abs. 3.6 (2.5-4.7) (MI) 2.0 (0.7-3.3); for functional status (RDQ) (abs), MI and (95%CI) (I) abs. 5.1 (3.1-7.1) (MI) 8.9 (7.010.8), (R) abs. 6.2 (4.1-8.4) 5.4 (3.0-7.8). For pain 12 months: (I) abs.2.8 (1.9-3.7) (MI) 3.2 (2.1-4.3), (R) abs. 3.9 (2.6-5.7) (MI) 1.8 (0.5-3.1); (RDQ) (abs.) (MI) (95%CI) (I) abs. 5.3 (3.2-7.4) (MI) 8.7 (6.8-10.6), (R) abs. 6.3 (3.8-8.8) (MI): 5.3 (2.6-8.0). Absolute RDQ values minor advantage for (I): six and 12 months, on MI significantly larger scores for (I). Pain, both abs. And MI significant better for (I), 12 months no differences between groups. Significantly more patients in (I) participation in daily activities (sub-scale WONCA) at six months. At six and 12 months no significant differences, for overall health or sick leave. No significant changes for analysis with only complete follow-up. Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomization “by random number table” Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Yes Incomplete outcome data addressed? Yes Similarity of baseline characteristics? No Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Dolan 2000 Methods “Blindly randomised” Participants 20 patients aged between 18 to 60 (18 men, three women) with radiological evidence of disc Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 20 Dolan 2000 (Continued ) prolapse associated with sciatica of less than 12 months duration. (N = 5 L4-L5), (N = 15 L5S1) Type of surgery: Microdiscectomy, followed by a six weeks normal postoperative care by physical therapy: advice about exercise and return to normal activities. Interventions (I) (N = 9) received an exercise program by experienced physiotherapist, two one hour sessions per week for four weeks, (start six weeks after surgery); progress at own pace, general aerobic exercises, stretching exercises, extension exercises strength and endurance exercises (back and abdominal). (R) (N = 11) no further treatment. Outcomes Pain intensity (VAS) and (Pain Diary): significant reduction in both groups six weeks after surgery, but (I) showed further decrease (within group) compared to (R). Between groups (12 months) pain (diary): significantly less pain (P < 0.05) in favor of (I) and for pain (VAS) not significant (P = 0.08). Functional status (range 0-75, high scores: good status): improvement in both groups after surgery: mean (SD) (I) 54 (24), (R) 50 (25). On 12 months no between group analysis. Behavioral outcomes: little change post-surgery and during follow-up. ROM and muscle endurance: no differences Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes “Blindly randomised” Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Yes Incomplete outcome data addressed? No Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Compliance acceptable? Yes Timing outcome assessments similar? Yes Unclear from text Donceel 1999 Methods Randomization “by computer-generated random number” Participants 710 patients (workers) that have mandatory insurance that introduced a benefit claim after open lumbar discectomy. Age between 15 to 64 and no longer than one year off work before surgery. Interventions start six weeks post-surgery Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 21 Interventions (I) (N = 345) Rehabilitation-oriented approach (in insurance medicine) by medical adviser (MA). First visit six weeks post-surgery, functional evaluation, information on medicolegal aspects, rehabilitation, natural history and expected work incapacity period. Encourage and stimulate personal activities and early mobilization. MA asks treating physician for information regarding diagnosis and treatment, encourages rehabilitation measures, promote multi-disciplinary approach. (R) (N = 365) MA: usual care Outcomes On return to work at follow-up (52 weeks): (I) 89.9% (R) 81.9%. Statistically significant Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomization “by computer-generated random number” Allocation concealment? No C - Inadequate Blinding? No Blinding? No Blinding? Unclear Incomplete outcome data addressed? Yes Incomplete outcome data addressed? Yes Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Compliance acceptable? Yes Timing outcome assessments similar? Yes Unclear from text Unclear from text Filiz 2005 Methods Randomized by opaque envelops prepared by independent person Participants 60 patients (three arms) included one month after first time lumbar disc surgery. Aged between 20 and 50. Only short-term follow-up Interventions (I1, N = 20) intensive exercise program and back school education under supervision for eight weeks; three days a week with sessions of 1.5 hours each (I2, N = 20) Back education and McKenzie and Williams exercise in home program for eight weeks; advice to practice three days/week (C, N = 20) No treatment Outcomes RTW in days (I1) 56.07 (18.66) vs (I2) 75.0 (24.9) vs (C) 86.2 (27.1). Pain (post treatment score on VAS): (I1) 4.5 (1.6) vs (I2) 12.0 (3.7) vs (C) 13.3 (7.3). Functional status (post treatment scores on Modified Oswestry): (I1) 7.1 (4.9) vs (I2) 11.7 (C) 15.1 (8.6) Notes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 22 Filiz 2005 (Continued ) Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized by opaque envelops prepared by independent person Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Unclear Unclear from text Incomplete outcome data addressed? Unclear Unclear from text Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Filiz 2005 (1) Methods see Filiz 2005 Participants Interventions Outcomes Notes Hakkinen 2005 Methods “Randomly assigned” Participants 126 patients included two months after their first lumbar disc surgery and not pain free (VAS > 10mm). Interventions (I) Home exercise program after one instruction session, for 12 months. Instructions for stretching and stabilization exercises, instructed to stretch three times AND strength training, Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 23 Hakkinen 2005 (Continued ) instructed to perform two series of exercises twice a week. (R) Home exercise program after one instruction session, for 12 months. Instructions for stretching and stabilization exercises, instructed to stretch three times Outcomes At 12 months follow-up: Improvement in back pain (100 mm VAS): (I) 4 mm (IQR: -11 to 5) vs (R) 1 mm (IQR : -7 to 9); leg pain (100 mm VAS): (I) -2 (IQR: -7 to 7) vs (R) -2 (IQR: -7 to 3). Improvement in disability (ODI) (I): 3 mm (IQR: -6 to 1) vs (R): -2 (-5 to 1). Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? No “Randomly assigned” Allocation concealment? Unclear B - Unclear Blinding? Unclear Unclear from text Blinding? Unclear Unclear from text Blinding? Unclear Unclear from text Incomplete outcome data addressed? Unclear Unclear from text Incomplete outcome data addressed? Unclear Unclear from text Similarity of baseline characteristics? Yes Co-interventions avoided or similar? No Compliance acceptable? Unclear Timing outcome assessments similar? Yes Unclear from text Johannsen 1994 Methods Randomized by minimization and stratified for sex, age (cut-off 40 years), +/- pre-operative hospitalisation, +/- post-operative complications Participants 40 patients undergoing a first lumbar diskectomy (L4-L5) for classic nerve root compression symptoms without cauda equina and confirmatory imaging; at least 2 weeks of unsuccessful conservative therapy; aged between 18-65, employed were included. Excluded: specific other diseases spine or hip or system diseases. Interventions start within four to six weeks after surgery Interventions (I) (N = 20) supervised group training (max 10 patients) one hour, twice a week for three months. Session: 10 minutes warming up bicycle, dynamic exercises (endurance) for low and high back, buttock and abdominal muscles supervised by PT. (R) (N = 20) individual training at home with two hours instruction by PT plus written instructions. Same exercises as (I). Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 24 Johannsen 1994 (Continued ) Outcomes Back pain (five-point scale): T0 , three, six months; median and 12.5 percentiles: (I): 4.1 (2.5 6.0), 2.8 (1.8 - 4.8), 2.8 (1.8 - 4.2), (R) 4.0 (2.0 - 5.9), 2.4 (1.7 - 4.2), 2.5 (1.8 - 5.8). Global Perceived Effect (four-point scale, 0 = good, 3 = bad): (I) 1,6 (0.8 - 2.5), 1.1 (0.7 - 1.9), 1.0 (0.6 - 1.5), (R) 1.4 (0.7 - 2.2), 1.2 (0.7 - 2.0), 1.3 (0.7 - 2.9). No differences except extension strength at three months for (R). ROM (sum-score in cm) (I): 12 (-3 - 26), 26 (19 - 41), 27 (8 - 37), (R) 16 (2 - 29), 23 (17 - 30), 26 (15 - 41). Disability (12-point scale with 12 = maximum disability) (I) 3 (0 - 4), 0 (0 - 2), 0 (0 - 3), (R) 2 (0 - 5), 0 (0 - 2), 0 (0 - 2) (NS). Isokentic trunk extension strength: (I) 36 (13 - 48), 45 (23 - 57), 50 (34 - 77), (R) 47 (12 59), 54 (35 - 69), 64 (45 - 73). Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized by minimization and stratified for sex Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? Unclear Incomplete outcome data addressed? No Incomplete outcome data addressed? No Similarity of baseline characteristics? Unclear Unclear from text Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Unclear from text Kjellby-Wendt 1998 Methods Randomized according to a table of random numbers Participants 60 patients (aged 16 to 70), microdiscectomy after not responding to conservative treatment. Patients with re-operation other surgery as microdiscectomy without microscope (e.g. laminectomy). Interventions start immediately after surgery Interventions (I) (N = 29) Total duration is 12 weeks, starting directly after surgery: out of bed from prone position, increase ADL & lumbar support (sitting). First six weeks home training (five to six times per day) with mobilization neural structures and low-back, increase trunk strength (functional positions), correct work posture, pain coping. Second six weeks (five to six times Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 25 Kjellby-Wendt 1998 (Continued ) per day) mainly intensive muscle strength and flexion exercises and cardiovascular exercises (in total: four instruction sessions) (R) Total duration 12 weeks, starting direct after surgery out of bed from side position, no increase of ADL and no lumbar support (sitting). First six weeks abdominal exercises (once a day) lying position. Second six weeks more intensive strength exercises, mobilization spine. No promotion cardiovascular exercises (total: three instruction sessions) Outcomes At two years satisfaction (I) 88%, (R) 67%. Percent positive SLR (three weeks) (I) 0 (R) seven, significant difference On six, 12, 52 weeks no significant differences. Extension (52 weeks): (I) 30 (14.8) and (R) flexion (42 (11.5) significantly increased. (I) eight patients pain-free (R) (4), (six weeks) no differences on 12, 52, 104 weeks. Leg Pain intensity (VAS) (in patients with sciatica) at six,12, 52 weeks (mean, SD): (I) 1.0 (0.6), 1.5 (0.9) 2.7 (0.5), (R) 4.1 (2.9), 3.4 (2.2), 3.0 (1.9) statistically significant at six, 12 weeks, not at 52 weeks. At five to seven years follow-up (I) 52%, (R) 50% pain (leg); (I) 73% (R) 60% pain (back). Patients on sick leave at 12 weeks (I) 10 (R) 15 (NS). At 52 weeks (I) 120 (75) days (R) 153 (107) on sick leave. At two years (I) 88% (R) 67% satisfied with result. (I) 10=40% (R) 8 = 33% no pain. During two to five years after surgery no differences in days of sick leave (I) 146 (SD: 243 days) (C) 157 days (SD:203). On the five to seven years follow-up no differences in number of patients with leg pain (I) 16/30 (C) 15/30, or number of patients with back pain (I) 22/30, (C) 18/30 Notes unpublished data were used Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized according to a table of random numbers Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? No Incomplete outcome data addressed? No Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 26 Manniche 1993a Methods Randomized by drawing of lots Participants 96 patient (49 men, 47 women) who had undergone first time discectomy for lumbar disc protrusion, aged 18 to 70. Interventions start five weeks after surgery Interventions Both groups: (in classes of two to six patients) in total 14 hours including five instruction & ergonomics sessions. (I) Intensive exercises: (start session hot packs & 5 heavy exercises: 1) leg lifting, 2) trunk lifting (one and two from 45O flexion to 0O), 3) abdominal exercise, 4) leg abduction 5) leg adduction (10 repetitions each). End of session: six minutes sub-maximal bicycle training & 5 stretching exercises. Six one-hour sessions, twice a week, next three weeks six 30-minute sessions in water (same principles, no limits to range of motion (including rotatory elements) Pain was no reason for stopping. (R) 15 mild general mobilization exercises, 10 repetitions each, program started with six 30-minute sessions (twice a week) in water. Next three weeks, same principles in gymnasium. If pain occurred: stop. Outcomes Overall improvement at 52 weeks (I) 76% (R) 70% “very satisfactory” or “satisfactory, little discomfort”. Not significantly different. Medians: pre-treatment post-treatment, six, 12, 26, 52 weeks: On low-back pain scale 0 to 30, (I) 5.5, 2.0, 1.8, 5.2, 3.7; (R) 7.1,3.4, 2.4,.5.5,6.5 no significant differences; on leg pain scale (0 to 30), (I) 4.5, 2.2, 3.0, 3.0, 0.8, (R) 4.8, 3.2, 3.0, 5.0, 2.2; no significant differences; on disability scale (0 to 30) (I) 10.8, 4.5, 4.4, 4.0, 4.2, (R) 11.5, 6.1, 4.3, 6.5, 6.0, statistically significant at 26 weeks. Physical impairment scale (0 to 40), pre-treatment, post-treatment and six weeks (I) 16.2, 11.8, 12.5, (R) 16.8, 11.8, 12.3, no significant different. All scales are sub-scales of Low-Back Pain Rating Scale (high scores denote poor outcome) Days of work in (I) significant less on 26 and 52 weeks. Number of patients not returned to work (I) 14.3% (R) 30%: statistically significant Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized by drawing of lots Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? No Incomplete outcome data addressed? Unclear Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Compliance acceptable? Yes Timing outcome assessments similar? Yes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Unclear from text Unclear from text 27 Manniche 1993b Methods Randomized by drawing envelopes Participants 62 patients (30 men, 32 women) with chronic low-back pain occurring 14 to 60 months after first time discectomy for lumbar disc protrusion and patients self reported global assessment of operation outcome was “good”, “fair” or “unchanged” . Interventions start 14 to 60 months post surgery Interventions (I) (N = 31) Intensive dynamic exercise with hyperextension, start session with hot pack (optional) (20 minutes), followed by 1) trunk lifting, 2) leg lifting,: one and two with greatest possible extension, 3) abdominal exercise. All in series of 10; one minute rest in between), 4) pull to neck (50 times). two sessions a week (one session: 60-90 minutes), total of 24 sessions in three months. (R) (N = 31) exactly same procedure, but in one and two movement range back and hip only from 90 degrees flexion to 0 degrees. No hyperextension. Outcomes Overall improvement post treatment, three months and one year (at one year (I) 38%, (R) 61% scored “very satisfactory” or “satisfactory, little discomfort”) not statistically significant.Improvement functional status (low-back pain rating scale 0 - 130) post-treatment, three, 12 months. (Median 10th -90th percentile): (I) 10 (0 - 31), 8 (-15 - 28), 3 (-11 - 23), (R) 7 (-13 - 22), 1 (-14 - 9), 0 (-26 - 9). Statistically significant at three months only. Posttreatment both groups significantly improve Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized by drawing envelopes Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? No Incomplete outcome data addressed? Yes Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Yes Compliance acceptable? Yes Timing outcome assessments similar? Yes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 28 Ostelo 2003 Methods Randomized by a-priori prepared, opaque and sealed envelopes. Participants 105 patients still suffering complaints six weeks post surgery. Interventions (I: N = 52.) Behavioral graded activity (operant therapy) using graded activity and positive reinforcement , time-contingency management . Based on baseline measurements an individually graded exercise training program established, using quota setting. in total 18 sessions (30 minutes a session) over a three months period. (R: N = 53) Physiotherapiy program: ADL instructions, exercise trunk muscles (increase strength and stability). mobilization exercises. Number of sessions (of 30 minutes each) at the discretion of therapists (max 18 sessions) Outcomes Global Perceived Effect: I: 48% recovered versus R: 67% (three short-term) and 75% (I) versus 73% on the one year follow-up. Functional status (24 item RDQ): I: mean improvement (5.2 SD: 5.9) versus (5.6 SD: 5.3) for R on the short term, long-term: I: (7.0 SD: 5.5) versus R: (7.0 SD: 5.3) Pain back (VAS): mean improvement : I: (9.3 SD: 27.8) vs R: (16.0 SD: 25.3) short-term; one year follow-up: I: (17.6 SD: 32.5) vs R: (22.4 SD: 33.0) Cost-effectiveness analysis: the total direct costs in behavioral graded activity are 639 EURO [95% CI: 91; 1368] higher than physiotherapy. Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomized by a-priori prepared, opaque and sealed envelopes. Allocation concealment? Yes A - Adequate Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? No Incomplete outcome data addressed? Yes Similarity of baseline characteristics? Yes Co-interventions avoided or similar? No Compliance acceptable? Yes Timing outcome assessments similar? Yes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 29 Scrimshaw 2001 Methods Randomisation by random numbers table, unclear concealment Participants 81 patients undergoing spinal surgery randomised, 59 of whom underwent laminectomy or discectomy. Others were operated for fusion Interventions (I) (N = 32) standard postoperative care (isometric and dynamic exercises, progress as tolerated) AND active and passive exercises for neural mobilization (six days in hospital, encouraged to continue for at least six weeks) (R) standard postoperative care ONLY (isometric and dynamic exercises, progress as tolerated) Outcomes Overall improvement at 12 months (I) 67.7% vs (R) 68.9%; Pain (VAS) six weeks score (I) 26.6 (SD:29.3) vs (R) 33.4 (SD:30.6); at 12 mos (I) 33.4 (SD:34.2) vs (R) 25.7 (SD:29.18); functional status (QBPQ) at six weeks (I) 34.9 (SD:22.9) vs (R) 30.4 (SD:22.8), at 12 months (I) 29.9 (SD:24.1) vs (R) 27.2 (24.8) Notes Unpublised data used for analyses so that only the 59 patients who underwent laminectomy or discectomy were included. Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes Randomisation by random numbers table Allocation concealment? Unclear B - Unclear Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Yes Incomplete outcome data addressed? Yes Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Yes Compliance acceptable? No Timing outcome assessments similar? Yes Timm 1994 Methods Randomly assigned Participants 250 employers (68 females) in manufacturing segment of automobile industry, aged 34 to 51, with chronic low-back pain for at least six months following a single-level lumbar laminectomy (L5 segment) performed at least one year before start experiment Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 30 Interventions (I1) (N = 50) Physical agents: three sessions/week for eight weeks (24 sessions) hot packs (20 minutes), ultrasound (paravertebral musculature 1.5W/cm2 , six minutes), TENS in non-clinical setting (100-msec pulse, 100 pulses/sec, “to tolerance”)(I2) (N = 50) joint manipulation: large-amplitude low velocity manual therapy procedures (Maitland grades III or IV) combined with oscillations or sustained stretches. (I3) low-tech exercise: McKenzie under supervision (plus spinal stabilization). (I4) (N = 50) high-tech exercise: cardiovascular. (bicycle), isotonic trunk muscle training (DAPRE), isokinetic exercises flexion/extension left/right rotation (Cybex TEF & TORSO) (R) (N = 50) no treatment. Outcomes Functional status (Oswestry) Mean (SD) pretest (I1) (I2) (I3) (I4) (R): 37 (2.6), 36 (4.1), 35 (4.0), 33 (4.7) 37 (1.8) posttest 37 (1.7), 32 (5.1), 14 (4.9), 15 (3.6) 37 (2.4). (I3) and (I4) significantly better (I1), (I2) (R). No significant differences between (I3) and (I4). ROM Flexion (modified-modified Schober in cm) Mean (SD) pretest (I1) (I2) (I3) (I4) (R): 6.4 (1.5), 6.3 (1.4), 6.3 (1.4), 6.3 (1.4) 6.3 (1.5) posttest: 6.3 (1.5), 6.5 (2.2), 8.8 (2.4), 9.1 (2.6), 6.2 (1.5). (I3) and (I4) significantly better (I1), (I2) (R). No significant differences between (I3) and (I4). Lifting force output (in N) Mean (SD) pretest (I1) (I2) (I3) (I4) (R): 374 (107), 387 (80), 352 (98), 356 (111), 360 (102) posttest: 378 (98), 382 (87), 627 (117), 705 (108), 363 (94). (I3) and (I4) significantly better (I1), (I2) (R). No significant differences between (I3) and (I4). Weeks to re-entry into treatment (I1) (I2) (I3) (I4) (R); Mean (SD): 2.0 (0.5), 5.7 (1.3), 91.4 (60.1), 52.8 (3.6), 1.6 (0.2). (I3) significantly better than others. (I3) significantly more cost-effective than other Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear Randomly assigned Allocation concealment? Unclear B - Unclear Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Unclear Unclear from text Incomplete outcome data addressed? Unclear Unclear from text Similarity of baseline characteristics? Yes Co-interventions avoided or similar? No Compliance acceptable? Yes Timing outcome assessments similar? Yes Yilmaz 2003 Methods Randomization or concealment not described Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 31 Yilmaz 2003 (Continued ) Participants 42 patients (22 male, 20 female), age (range: 22-60) included one month after first time Interventions (I1, N = 14) dynamic lumbar stabilization exercise for eight weeks under supervision; (I2, N = 14) Flexion - extension program (Williams-McKenzie) home program for eight weeks; (C) no treatment. Outcomes Pain (VAS scores at post treatment) (I1) 1.14 (0.86) vs (I2) 2.93 (2.02) vs (C) 4.29 (1.90). Functional status (Scores on Modified Oswestry at post treatment) (I1) 8.5 (4.8) vs (I2) 12.93 (4.23) vs (C) 17.71 (6.23) Notes Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear Not described in text Allocation concealment? Unclear B - Unclear Blinding? No Blinding? No Blinding? No Incomplete outcome data addressed? Unclear Unclear from text Incomplete outcome data addressed? Unclear Unclear from text Similarity of baseline characteristics? Yes Co-interventions avoided or similar? Unclear Unclear from text Compliance acceptable? Unclear Unclear from text Timing outcome assessments similar? Yes Yilmaz 2003 (1) Methods Participants Interventions Outcomes Notes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 32 Characteristics of excluded studies [ordered by study ID] Study Reason for exclusion Brennan 1994 not randomised Burke 1994 not randomised Kitteringham 1996 not randomised Lavyne 1992 no active rehabilitation but epidural corticosteroids Le Roux 1999 no active rehabilitation but Ketorolac during wound closure Rotthaupt 1997 no adequate randomisation (date of birth) Woischnek 2000 descriptive pilot study Characteristics of ongoing studies [ordered by study ID] Selkowitz 2006 Trial name or title The immediate and long-term effects of exercise and patient education on physical, functional, and quality-oflife outcome measures after single-level lumbar microdiscectomy: a randomised controlled trial protocol. Methods Participants Patients after single level lumbar microdiscectomy Interventions Excercis versus patient education Outcomes Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, SF-36 quality of life assessment, Subjective Quality of Life Scale, 50-foot Walk, Repeated Sit-to-Stand, and a modified Sorensen test. Starting date Contact information Selkowitz, Department of Physical Therapy Education, Western University of Health Sciences, 309 E. Second St., Pomona, CA 91766, USA Notes Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 33 DATA AND ANALYSES Comparison 1. Treatments that start four to six weeks post-surgery. Exercise versus no treatment No. of studies No. of participants 1 Pain on VAS (post-treatment) 5 122 Mean Difference (IV, Random, 95% CI) 2 Functional status on Modified Oswestry (post-treatment) 4 102 Mean Difference (IV, Random, 95% CI) Outcome or subgroup title Statistical method Effect size -11.13 [-18.44, 3.82] -6.50 [-9.26, -3.74] Comparison 2. Treatments that start four to six weeks post-surgery. High-intensity exercise versus low-intensity exercise programs No. of studies No. of participants 1 Pain (short-term) 2 103 Mean Difference (IV, Random, 95% CI) 2 Function (short-term) 2 103 Std. Mean Difference (IV, Random, 95% CI) Outcome or subgroup title Statistical method Effect size -10.67 [-17.04, 4.30] -0.77 [-1.17, -0.36] Comparison 3. Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises Outcome or subgroup title 1 Functional status (short-term) 2 Pain (short-term) No. of studies No. of participants Statistical method 3 3 95 95 Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Effect size -1.17 [-2.63, 0.28] -1.12 [-2.77, 0.53] 34 Analysis 1.1. Comparison 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment, Outcome 1 Pain on VAS (post-treatment). Review: Rehabilitation after lumbar disc surgery Comparison: 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment Outcome: 1 Pain on VAS (post-treatment) Study or subgroup Treatment N No treatment Mean(SD) Dolan 2000 Mean Difference N Mean(SD) Weight IV,Random,95% CI Mean Difference IV,Random,95% CI 9 18 (7) 11 30 (8) 23.7 % -12.00 [ -18.58, -5.42 ] Filiz 2005 20 4.5 (1.59) 10 13.25 (7.34) 26.2 % -8.75 [ -13.35, -4.15 ] Filiz 2005 (1) 20 12 (3.67) 10 13.25 (7.34) 26.0 % -1.25 [ -6.08, 3.58 ] Yilmaz 2003 14 11.4 (8.6) 7 42.9 (19) 13.3 % -31.50 [ -46.28, -16.72 ] Yilmaz 2003 (1) 14 29.3 (20.2) 7 42.9 (19) 10.8 % -13.60 [ -31.21, 4.01 ] Total (95% CI) 77 45 100.0 % -11.13 [ -18.44, -3.82 ] Heterogeneity: Tau2 = 47.49; Chi2 = 19.10, df = 4 (P = 0.00075); I2 =79% Test for overall effect: Z = 2.98 (P = 0.0028) -50 -25 0 25 Favours treatment 50 Favours control Analysis 1.2. Comparison 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment, Outcome 2 Functional status on Modified Oswestry (post-treatment). Review: Rehabilitation after lumbar disc surgery Comparison: 1 Treatments that start four to six weeks post-surgery. Exercise versus no treatment Outcome: 2 Functional status on Modified Oswestry (post-treatment) Study or subgroup Treatment N No treatment Mean(SD) N Mean Difference Mean(SD) Weight IV,Random,95% CI Mean Difference IV,Random,95% CI Filiz 2005 20 7.05 (4.87) 10 15.1 (8.55) 23.4 % -8.05 [ -13.76, -2.34 ] Filiz 2005 (1) 20 11.65 (7.21) 10 15.1 (8.55) 20.0 % -3.45 [ -9.62, 2.72 ] Yilmaz 2003 14 8.5 (4.83) 7 17.71 (6.23) 27.5 % -9.21 [ -14.47, -3.95 ] Yilmaz 2003 (1) 14 12.93 (4.23) 7 17.71 (6.23) 29.1 % -4.78 [ -9.90, 0.34 ] 100.0 % -6.50 [ -9.26, -3.74 ] Total (95% CI) 68 34 Heterogeneity: Tau2 = 0.0; Chi2 = 2.67, df = 3 (P = 0.44); I2 =0.0% Test for overall effect: Z = 4.61 (P < 0.00001) -20 -10 Favours treatment Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 0 10 20 Favours control 35 Analysis 2.1. Comparison 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus low-intensity exercise programs, Outcome 1 Pain (short-term). Review: Rehabilitation after lumbar disc surgery Comparison: 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus low-intensity exercise programs Outcome: 1 Pain (short-term) Study or subgroup High intensity N Low intensity Mean(SD) N Mean Difference Mean(SD) Weight IV,Random,95% CI Mean Difference IV,Random,95% CI Danielsen 2000 39 23 (4.6) 24 37 (5.6) 48.8 % -14.00 [ -16.67, -11.33 ] Filiz 2005 20 4.5 (1.59) 20 12 (3.67) 51.2 % -7.50 [ -9.25, -5.75 ] Total (95% CI) 59 100.0 % -10.67 [ -17.04, -4.30 ] 44 Heterogeneity: Tau2 = 19.80; Chi2 = 15.95, df = 1 (P = 0.00007); I2 =94% Test for overall effect: Z = 3.28 (P = 0.0010) -20 -10 0 10 Favours treatment 20 Favours control Analysis 2.2. Comparison 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus low-intensity exercise programs, Outcome 2 Function (short-term). Review: Rehabilitation after lumbar disc surgery Comparison: 2 Treatments that start four to six weeks post-surgery. High-intensity exercise versus low-intensity exercise programs Outcome: 2 Function (short-term) Study or subgroup High intensity N Low intensity Mean(SD) N Std. Mean Difference Mean(SD) Weight IV,Random,95% CI Std. Mean Difference IV,Random,95% CI Danielsen 2000 39 5.1 (1.25) 24 6.1 (1.25) 59.7 % -0.79 [ -1.32, -0.26 ] Filiz 2005 20 7.05 (4.87) 20 11.65 (7.21) 40.3 % -0.73 [ -1.38, -0.09 ] Total (95% CI) 59 100.0 % -0.77 [ -1.17, -0.36 ] 44 Heterogeneity: Tau2 = 0.0; Chi2 = 0.02, df = 1 (P = 0.89); I2 =0.0% Test for overall effect: Z = 3.69 (P = 0.00023) -2.09 -1.045 Favours treatment Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 0 1.045 2.09 Favours control 36 Analysis 3.1. Comparison 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises, Outcome 1 Functional status (short-term). Review: Rehabilitation after lumbar disc surgery Comparison: 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises Outcome: 1 Functional status (short-term) Study or subgroup Supervised N Home Mean(SD) N Std. Mean Difference Mean(SD) Weight IV,Random,95% CI Std. Mean Difference IV,Random,95% CI Filiz 2005 20 4.5 (1.59) 20 12 (3.67) 32.9 % -2.60 [ -3.46, -1.74 ] Johannsen 1994 11 0 (0.87) 16 0 (0.87) 33.7 % 0.0 [ -0.77, 0.77 ] Yilmaz 2003 14 8.5 (4.83) 14 12.93 (4.23) 33.5 % -0.95 [ -1.74, -0.16 ] 100.0 % -1.17 [ -2.63, 0.28 ] Total (95% CI) 45 50 Heterogeneity: Tau2 = 1.49; Chi2 = 19.63, df = 2 (P = 0.00005); I2 =90% Test for overall effect: Z = 1.58 (P = 0.11) -4.01 -2.005 0 Favours treatment 2.005 4.01 Favours control Analysis 3.2. Comparison 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises, Outcome 2 Pain (short-term). Review: Rehabilitation after lumbar disc surgery Comparison: 3 Treatments that start four to six weeks post-surgery. Supervised programs versus home exercises Outcome: 2 Pain (short-term) Study or subgroup Supervised N Home Mean(SD) N Std. Mean Difference Mean(SD) Weight IV,Random,95% CI Std. Mean Difference IV,Random,95% CI Filiz 2005 20 4.5 (1.59) 20 12 (3.67) 33.0 % -2.60 [ -3.46, -1.74 ] Johannsen 1994 11 2.8 (1.3) 16 2.4 (1.08) 33.6 % 0.33 [ -0.44, 1.10 ] Yilmaz 2003 14 11.4 (8.6) 14 29.3 (20.2) 33.4 % -1.12 [ -1.92, -0.31 ] 100.0 % -1.12 [ -2.77, 0.53 ] Total (95% CI) 45 50 Heterogeneity: Tau2 = 1.95; Chi2 = 24.65, df = 2 (P<0.00001); I2 =92% Test for overall effect: Z = 1.33 (P = 0.18) -4.01 -2.005 Favours treatment Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 0 2.005 4.01 Favours control 37 APPENDICES Appendix 1. MEDLINE search strategy 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. exp “Clinical Trial [Publication Type]”/ randomized.ab,ti. placebo.ab,ti. dt.fs. randomly.ab,ti. trial.ab,ti. groups.ab,ti. or/1-7 Animals/ Humans/ 9 not (9 and 10) 8 not 11 dorsalgia.ti,ab. exp Back Pain/ backache.ti,ab. (lumbar adj pain).ti,ab. coccyx.ti,ab. coccydynia.ti,ab. sciatica.ti,ab. sciatica/ spondylosis.ti,ab. lumbago.ti,ab. or/13-22 exp Spine/ discitis.ti,ab. exp Spinal Diseases/ (disc adj degeneration).ti,ab. (disc adj prolapse).ti,ab. (disc adj herniation).ti,ab. spinal fusion.sh. spinal neoplasms.sh. (facet adj joints).ti,ab. intervertebral disk.sh. postlaminectomy.ti,ab. arachnoiditis.ti,ab. (failed adj back).ti,ab. or/24-36 Oswestry.tw. Roland-Morris.tw. or/38-39 23 or 37 or 40 exp Physical Therapy Modalities/ physiotherapy.mp. exp Rehabilitation/ rehabilitation.mp. exp Exercise/ exp Exercise Movement Techniques/ exercise.mp. or/42-48 Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 38 50. 12 and 41 and 49 Appendix 2. EMBASE search strategy 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. Clinical article/ clinical study/ Clinical trial/ controlled study/ randomized controlled trial/ major clinical study/ double blind procedure/ multicenter study/ single blind procedure/ phase 3 clinical trial/ phase 4 clinical trial/ crossover procedure/ placebo/ or/1-13 allocat$.mp. assign$.mp. blind$.mp. (clinica$ adj25 (study or trial)).mp. compar$.mp. control$.mp. cross?over.mp. factorial$.mp. follow?up.mp. placebo$.mp. prospectiv$.mp. random$.mp. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).mp. trial.mp. (versus or vs).mp. or/15-29 14 or 30 human/ nonhuman/ animal/ animal experiment/ 33 or 34 or 35 32 not 36 31 not 36 31 and 37 38 not 39 dorsalgia.mp. exp back pain/ backache.mp. (lumbar adj pain).mp. coccyx.mp. coccydynia.mp. sciatica.mp. sciatica/ spondylosis.mp. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 39 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. lumbago.mp. or/41-50 exp spine/ discitis.mp. exp spinal diseases/ (disc adj degeneration).mp. (disc adj prolapse).mp. (disc adj herniation).mp. spinal fusion.mp. spinal neoplasms.mp. (facet adj joints).mp. intervertebral disk.mp. postlaminectomy.mp. arachnoiditis.mp. (failed adj back).mp. or/52-64 Oswestry.mp. roland-morris.mp. 66 or 67 51 or 65 or 68 exp PHYSIOTHERAPY/ exp REHABILITATION/ exp EXERCISE/ physical therapy.mp. exercise.mp. rehabilitation.mp. physiotherapy.mp. or/70-76 40 and 69 and 77 Appendix 3. CINAHL search strategy 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. Randomized Controlled Trials.mp. clinical trial.pt. exp Clinical Trials/ (clin$ adj25 trial$).tw. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw. exp PLACEBOS/ placebo$.tw. random$.tw. exp Study Design/ (latin adj square).tw. exp Comparative Studies/ exp Evaluation Research/ Follow-Up Studies.mp. exp Prospective Studies/ (control$ or prospectiv$ or volunteer$).tw. Animals/ or/1-15 17 not 16 dorsalgia.mp. exp Back Pain/ backache.mp. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 40 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. (lumbar adj pain).mp. [mp=title, subject heading word, abstract, instrumentation] exp COCCYX/ exp SCIATICA/ coccyx.mp. sciatica.mp. exp Low Back Pain/ coccydynia.mp. sciatica.mp. or exp SCIATICA/ exp Lumbar Vertebrae/ or exp Spondylolisthesis/ or exp Spondylolysis/ lumbago.mp. or/19-31 exp SPINE/ exp Intervertebral Disk/ exp Spinal Diseases/ (disc adj degeneration).mp. [mp=title, subject heading word, abstract, instrumentation] (disc adj prolapse).mp. [mp=title, subject heading word, abstract, instrumentation] (disc adj herniation).mp. [mp=title, subject heading word, abstract, instrumentation] exp Spinal Fusion/ (facet adj joint$).mp. [mp=title, subject heading word, abstract, instrumentation] exp Laminectomy/ exp KYPHOSIS/ (failed adj back).mp. [mp=title, subject heading word, abstract, instrumentation] or/33-43 oswestry.mp. roland-morris.mp. or/45-46 32 or 44 or 47 exp Physical Therapy/ physiotherapy.mp. exp REHABILITATION/ rehabilitation.mp. exp EXERCISE/ exercise.mp. or/49-54 18 and 48 and 55 Appendix 4. PsycINFO search strategy (KW=(Randomized controlled trial?) or KW=(clinical trial?) or KW=(clin* within 25 trial*) or kw=(sing* within 25 blind*) or kw=(sing* within 25 mask*) or kw=(doubl* within 25 blind*) or kw=(doubl* within 25 mask*) or kw=(trebl* within 25 blind) or kw=(trebl* within 25 mask*) or kw=(tripl* within 25 blind*) or kw=(tripl* within 25 mask*) or KW=(placebo*) or KW=(random*) or DE=(Research Design) or KW=(Latin square) or KW=(comparative stud*) or KW=(evaluation stud*) or kw=(follow up stud*) or DE=(Prospective studies) or KW= (control*) or KW=(prospective*) or KW=(volunteer*)) and (DE=(back) or DE = (back pain) or DE=(neck)) and (KW=(physiotherapy) or DE=(rehabilitation) or DE=(exercise) or DE=(physical therapy) or KW=(lumbar diskectomy)or KW=(post operative) or KW=(discectomy) or KW=(back surgery) or KW=(lumbar surgery)or KW=(lumbar disk herniation)) Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 41 FEEDBACK Comments on version of review published in The Cochrane Library 2002, issue 2 Summary January 2005 Feedback 1: The results are described almost entirely in terms of whether or not they were statistically significant, and very few numbers are presented. It would be much more informative to state how big the differences between the groups were (a relative risk or mean difference, or other measure of the size of the difference), with a confidence interval to indicate the uncertainty around the estimate. The statistical significance of a result is of little importance, and alone is very uninformative. Feedback 2: Thanks for this - I just wanted to correct a possible misunderstanding. I wasn’t criticising the lack meta-analysis and overall effect estimate - this is a very reasonable position when the trials are heterogeneous. My criticism was about description of the results of the included trials as “statistically significant” or not, which does not give much idea of the size of the differences that they found. It would be much better to quote risk ratios or differences and confidence intervals. Reply Response 1: It is always more informative if one can calculate an overall effect size ... provided there are sufficient data and it makes clinical sense to do so. However, you have identified the challenges facing authors who try to synthesize the data in this field. The authors only found 13 studies that met the inclusion criteria, and felt that for the studies that did include sufficient data, there was too much heterogeneity in the duration and intensity of the interventions and the timing of outcome measures to pool the data. You also comment on the lack of clinical relevance. Our guidelines have now changed, and ask authors to include this parameter in their reviews. Since this review is due for updating, I would anticipate the author including this in the updated review. I will pass on your comments to the authors, so that they can take consider them as they complete the update. Response 2: thanks for clarifying. And the editorial board does agree with you! As I’m sure you are aware, authors often describe their results as ’statistically’ significant because they are, but for a variety of reasons their results really mean little or nothing from a clinical perspective. The rheumatology field is ahead of the back pain field in definitions, calculations and reporting of minimum clinically important differences. At our last international forum on back pain research (Edmonton, Canada, October 2004) there was a lot of discussion on this, but no consensus yet. There has been some consensus on patient-centred outcomes of import, but again, the older trials don’t necessarily follow this. The other really unfortunate thing is that much of the literature just doesn’t give any stats at all! The newer trials are better, but its still an uphill battle, despite the widespread acceptance of the CONSORT and TREND statements. Contributors Dr Simon Gates, Trials Researcher/Statistician Victoria Pennick, Back Group Coordinator WHAT’S NEW Last assessed as up-to-date: 14 November 2007 Date Event Description 23 June 2008 Amended Converted to new review format. 19 March 2008 New citation required and conclusions have changed In contrast to the original review, we only included RCTs in this update. In total, five new RCTs were Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 42 (Continued ) Date Event Description included, yielding a total of 14 included RCTs. Therefore, it was now possible to pool the data in three comparisons. In addition, in this update we used the GRADE approach, as recommended by the Editorial Board of the Cochrane Back Review Group (CBRG), while in the original review the ’levels of evidence’ approach was used. The following ’new’ results were found, none of which are supported by high quality evidence 1) Adding neural mobilization to an exercise program is not effective on pain and functional disability in the short-term and the long-term. 2) Exercise programs that start four to six weeks postsurgery lead to a faster decrease in pain and functional disability as compared to no treatment 3) A behavioural graded activity program is not more effective than a standard physiotherapy program 4) Supervised training does not seem to be more effective than home-based training in the short-term. 19 May 2007 New search has been performed The literature search was updated to May 19, 2007. Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 43 HISTORY Protocol first published: Issue 2, 2001 Review first published: Issue 2, 2002 Date Event Description 1 June 2007 New search has been performed the literature search was updated to June 1st, 2007 CONTRIBUTIONS OF AUTHORS Pairs of review authors (Henrica de Vet & Maurits van Tulder and for the update Raymond Ostelo & Leonardo Costa) identified and selected all studies. Also in pairs, Leonardo Costa, Christopher Maher, Maurits van Tulder and Raymond Ostelo assessed the methodological quality of studies and performed the data extraction. Raymond Ostelo, Henrica de Vet and Maurits van Tulder conducted the data analyses. All review authors were involved in writing the review protocol and the final draft of the review. DECLARATIONS OF INTEREST Raymond Ostelo, first author of this review, is also the first author of one of the included studies. As this is a potential conflict of interest, he was not involved in the methodological quality assessment, data extraction or any other decision regarding this trial. INDEX TERMS Medical Subject Headings (MeSH) ∗ Exercise Therapy; Intervertebral Disk [∗ surgery]; ∗ Lumbar Vertebrae; Postoperative Period; Recovery of Function MeSH check words Humans Rehabilitation after lumbar disc surgery (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. View publication stats 44