To standardize outcome reporting in clinical trials of patients with non-specific low back pain (... more To standardize outcome reporting in clinical trials of patients with non-specific low back pain (LBP), an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of consensus on measurement instruments for these three domains in patients with LBP, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, three for pain intensity, and five for HRQoL were appraised in three systematic reviews following COSMIN methodology. Researchers, clinicians and patients (n = 207) were invited in a two-round Delphi survey to generate consensus ( ≥ 67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In Round 1, consensus was achieved on the Oswestry Disability Index version 2.1a (ODI 2.1a) for physical functioning (78% agreement) and the Numeric ...
Journal of neurology, neurosurgery, and psychiatry, Jan 26, 2017
The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscect... more The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy. The study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randoml...
The spine journal : official journal of the North American Spine Society, Jan 21, 2017
Background context In clinical practice, the diagnosis of cervical radiculopathy is based on info... more Background context In clinical practice, the diagnosis of cervical radiculopathy is based on information from the patient history, physical examination and diagnostic imaging. Various physical tests may be performed, but their diagnostic accuracy is unknown. Purpose To summarize and update the evidence on diagnostic performance of tests carried out during a physical examination for the diagnosis of cervical radiculopathy. Study design Review of the accuracy of diagnostic tests. Study Sample Diagnostic studies comparing results of tests performed during a physical examination in diagnosing cervical radiculopathy with a reference standard of imaging or surgical findings. Outcome measures Sensitivity, specificity, likelihood ratios are presented, together with pooled results for sensitivity and specificity. Methods A literature search up to March 2016 was performed in CENTRAL, PubMed (MEDLINE), EMBASE, CINAHL, Web of Science and Google Scholar. Methodological quality of studies was ass...
Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is ef... more Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. A total of 209 patients underwent randomization, of whom 108 rec...
although back pain is most prevalent in older adults, there is a paucity of studies investigating... more although back pain is most prevalent in older adults, there is a paucity of studies investigating back pain in older people. Our objective was to characterize and compare Brazilian and Dutch older adults presenting to primary care with a new episode of back pain. We also aimed to investigate whether socio-demographic characteristics were associated with pain severity and disability. we sourced data on 602 Brazilian and 675 Dutch participants aged ≥55 years with a new episode of back pain from the Back Complaints in the Elders consortium. We analyzed country differences in participants' characteristics, and associations between socio-demographic/clinical characteristics and pain severity and pain-related disability. the two populations differed in most characteristics. More Dutch participants were smokers, heavy drinkers, and reported back stiffness. More Brazilian participants were less educated, had higher prevalence of comorbidities; higher levels of pain intensity, disability...
Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of... more Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease globally. Strong analgesics, such as opioid analgesics, are recommended by clinical guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. Opioid analgesics are widely and increasingly used, but there are no strong efficacy data supporting the use of opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened by the risks of adverse events, some of which can be serious (eg, dependency, misuse and overdose). OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (controlled release oxycodone plus naloxone up to 20 mg per...
In a small proportion of patients experiencing unspecified back pain a specified underlying patho... more In a small proportion of patients experiencing unspecified back pain a specified underlying pathology is present. To identify the prevalence of physician-specified causes of back pain and to assess associations between red flags and vertebral fractures, as diagnosed by the patients' GP, in older adults presenting with back pain in general practice. The BACE study is a prospective cohort study. Patients (aged >55 years) with back pain were included when consulting their general practitioner (GP). A questionnaire, physical examination, and heel bone densitometry were performed and determined back pain and patient characteristics, including red flags. Patients received an X-ray and reports were send to the patients' GP. The final diagnoses established at 1 year were collected from the GPs patient registry. Of the 669 patients included, 6% were diagnosed during 1 year follow-up with a serious underlying pathology. Most of these patients (n=33, 5%) were diagnosed with a verteb...
Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, a... more Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that sh...
The Cochrane database of systematic reviews, Jan 31, 2013
Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical... more Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. Studies were considered if they compared the results of any aspect of the history or test conducted in the physical exa...
Background Few data are available on the course of and predictors for disability in patients with... more Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on...
The choice of a specific surgical technique should be based on its benefits and harms. Previous r... more The choice of a specific surgical technique should be based on its benefits and harms. Previous reviews have shown that the benefit of surgery over conservative care is not clearly demonstrated in patients with disorders of the cervical spine. Also, no additional benefit of fusion upon anterior decompression techniques could be found. A clear overview of other surgical techniques is lacking. We therefore aimed to assess the benefits and harms of cervical spinal surgery in patients with cervical disorders. We searched MEDLINE, EMBASE, CINAHL, and CENTRAL up to June 2012. Randomized controlled trials (RCTs) were selected which included adults with cervical disorders receiving a surgical intervention and that reported at least 1 clinically relevant outcome measure (eg, pain, function, recovery). Two authors independently assessed the risk of bias using the criteria recommended by the Cochrane Back Review Group and extracted the data. The quality of the evidence was rated using the GRADE method. We included 39 RCTs comparing different surgical interventions. We found low-quality evidence for no difference in effectiveness between various surgical techniques used for anterior discectomy. There is a small, clinically irrelevant benefit on recovery and pain in favour of prosthetic disc surgery when compared with fusion techniques. Unfortunately, in these studies the authors had a clear conflict of interest. The differences in benefits and harms between the various surgical techniques are small. The surgeon, patient, and health care provider can therefore make the choice of any surgical technique based on experience, preferences, or costs.
To standardize outcome reporting in clinical trials of patients with non-specific low back pain (... more To standardize outcome reporting in clinical trials of patients with non-specific low back pain (LBP), an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of consensus on measurement instruments for these three domains in patients with LBP, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, three for pain intensity, and five for HRQoL were appraised in three systematic reviews following COSMIN methodology. Researchers, clinicians and patients (n = 207) were invited in a two-round Delphi survey to generate consensus ( ≥ 67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In Round 1, consensus was achieved on the Oswestry Disability Index version 2.1a (ODI 2.1a) for physical functioning (78% agreement) and the Numeric ...
Journal of neurology, neurosurgery, and psychiatry, Jan 26, 2017
The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscect... more The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy. The study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randoml...
The spine journal : official journal of the North American Spine Society, Jan 21, 2017
Background context In clinical practice, the diagnosis of cervical radiculopathy is based on info... more Background context In clinical practice, the diagnosis of cervical radiculopathy is based on information from the patient history, physical examination and diagnostic imaging. Various physical tests may be performed, but their diagnostic accuracy is unknown. Purpose To summarize and update the evidence on diagnostic performance of tests carried out during a physical examination for the diagnosis of cervical radiculopathy. Study design Review of the accuracy of diagnostic tests. Study Sample Diagnostic studies comparing results of tests performed during a physical examination in diagnosing cervical radiculopathy with a reference standard of imaging or surgical findings. Outcome measures Sensitivity, specificity, likelihood ratios are presented, together with pooled results for sensitivity and specificity. Methods A literature search up to March 2016 was performed in CENTRAL, PubMed (MEDLINE), EMBASE, CINAHL, Web of Science and Google Scholar. Methodological quality of studies was ass...
Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is ef... more Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. A total of 209 patients underwent randomization, of whom 108 rec...
although back pain is most prevalent in older adults, there is a paucity of studies investigating... more although back pain is most prevalent in older adults, there is a paucity of studies investigating back pain in older people. Our objective was to characterize and compare Brazilian and Dutch older adults presenting to primary care with a new episode of back pain. We also aimed to investigate whether socio-demographic characteristics were associated with pain severity and disability. we sourced data on 602 Brazilian and 675 Dutch participants aged ≥55 years with a new episode of back pain from the Back Complaints in the Elders consortium. We analyzed country differences in participants' characteristics, and associations between socio-demographic/clinical characteristics and pain severity and pain-related disability. the two populations differed in most characteristics. More Dutch participants were smokers, heavy drinkers, and reported back stiffness. More Brazilian participants were less educated, had higher prevalence of comorbidities; higher levels of pain intensity, disability...
Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of... more Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease globally. Strong analgesics, such as opioid analgesics, are recommended by clinical guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. Opioid analgesics are widely and increasingly used, but there are no strong efficacy data supporting the use of opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened by the risks of adverse events, some of which can be serious (eg, dependency, misuse and overdose). OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (controlled release oxycodone plus naloxone up to 20 mg per...
In a small proportion of patients experiencing unspecified back pain a specified underlying patho... more In a small proportion of patients experiencing unspecified back pain a specified underlying pathology is present. To identify the prevalence of physician-specified causes of back pain and to assess associations between red flags and vertebral fractures, as diagnosed by the patients' GP, in older adults presenting with back pain in general practice. The BACE study is a prospective cohort study. Patients (aged >55 years) with back pain were included when consulting their general practitioner (GP). A questionnaire, physical examination, and heel bone densitometry were performed and determined back pain and patient characteristics, including red flags. Patients received an X-ray and reports were send to the patients' GP. The final diagnoses established at 1 year were collected from the GPs patient registry. Of the 669 patients included, 6% were diagnosed during 1 year follow-up with a serious underlying pathology. Most of these patients (n=33, 5%) were diagnosed with a verteb...
Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, a... more Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that sh...
The Cochrane database of systematic reviews, Jan 31, 2013
Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical... more Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. Studies were considered if they compared the results of any aspect of the history or test conducted in the physical exa...
Background Few data are available on the course of and predictors for disability in patients with... more Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on...
The choice of a specific surgical technique should be based on its benefits and harms. Previous r... more The choice of a specific surgical technique should be based on its benefits and harms. Previous reviews have shown that the benefit of surgery over conservative care is not clearly demonstrated in patients with disorders of the cervical spine. Also, no additional benefit of fusion upon anterior decompression techniques could be found. A clear overview of other surgical techniques is lacking. We therefore aimed to assess the benefits and harms of cervical spinal surgery in patients with cervical disorders. We searched MEDLINE, EMBASE, CINAHL, and CENTRAL up to June 2012. Randomized controlled trials (RCTs) were selected which included adults with cervical disorders receiving a surgical intervention and that reported at least 1 clinically relevant outcome measure (eg, pain, function, recovery). Two authors independently assessed the risk of bias using the criteria recommended by the Cochrane Back Review Group and extracted the data. The quality of the evidence was rated using the GRADE method. We included 39 RCTs comparing different surgical interventions. We found low-quality evidence for no difference in effectiveness between various surgical techniques used for anterior discectomy. There is a small, clinically irrelevant benefit on recovery and pain in favour of prosthetic disc surgery when compared with fusion techniques. Unfortunately, in these studies the authors had a clear conflict of interest. The differences in benefits and harms between the various surgical techniques are small. The surgeon, patient, and health care provider can therefore make the choice of any surgical technique based on experience, preferences, or costs.
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