Review
How does surgery compare to sham
surgery or physiotherapy as a treatment
for tendinopathy? A systematic review
of randomised trials
Dimitrios Challoumas,1 Christopher Clifford,1,2 Paul Kirwan,3,4 Neal L Millar
To cite: Challoumas D,
Clifford C, Kirwan P, et al. How
does surgery compare to sham
surgery or physiotherapy as a
treatment for tendinopathy?
A systematic review of
randomised trials. BMJ Open
Sport & Exercise Medicine
2019;5:e000528. doi:10.1136/
bmjsem-2019-000528
Accepted 26 March 2019
© Author(s) (or their
employer(s)) 2019. Re-use
permitted under CC BY.
Published by BMJ.
1
Institute of Infection, Immunity
and Inflammation, College of
Medicine,Veterinary and Life
Sciences, University of Glasgow,
Glasgow, UK
2
Department of Physiotherapy,
NHS Greater Glasgow and Clyde,
Glasgow, UK
3
School of Physiotherapy, Royal
College of Surgeons in Ireland,
Dublin, Ireland
4
Physiotherapy
Department, Connolly
Hospital Blanchardstown,
Blanchardstown, Ireland
Correspondence to
Mr Neal L Millar;
neal.millar@glasgow.ac.uk
AbsTrACT
Purpose To assess the effectiveness of surgery on all
tendinopathies by comparing it to no treatment, sham
surgery and exercise-based therapies for both mid-term
(12 months) and long-term (> 12 months) outcomes.
Methods Our literature search included EMBASE,
Medline, CINAHL and Scopus. A combined assessment
of internal validity, external validity and precision of each
eligible study yielded its overall study quality. Results were
considered significant if they were based on strong (Level
1) or moderate (Level 2) evidence.
results 12 studies were eligible. Participants had the
following types of tendinopathy: shoulder in seven studies,
lateral elbow in three, patellar in one and Achilles in one.
Two studies were of good, four of moderate and six of
poor overall quality. Surgery was superior to no treatment
or placebo, for the outcomes of pain, function, range of
movement (ROM) and treatment success in the short and
midterm. Surgery had similar effects to sham surgery
on pain, function and range of motion in the midterm.
Physiotherapy was as effective as surgery both in the
midterm and long term for pain, function, ROM and tendon
force, and pain, treatment success and quality of life,
respectively.
Conclusion We recommend that healthcare
professionals who treat tendinopathy encourage patients
to comply with loading exercise treatment for at least
12 months before the option of surgery is seriously
entertained.
InTroduCTIon
Tendinopathy poses a substantial socioeconomic burden globally comprising 30% of
all general practice musculoskeletal consultations.1 Its aetiology is multifactorial and its
exact pathophysiology remains uncertain;
however, it appears to result from an imbalance between the protective/regenerative
changes and the pathological responses that
result from tendon overuse.2 3 The the most
common exacerbating factor is thought to be
overuse (particularly during sporting activities) causing repetitive microtrauma and
consequent degeneration due to failure of
1
What is already known?
► Much debate surrounds the role of surgical inter-
vention in chronic tendon disease. Sham surgery
trials are the gold standard against which to judge
the effect of surgery on clinical conditions (such as
tendinopathy).
What are the new findings?
► In 12 eligible randomised controlled trials in patients
with various tendinopathies, surgery was not superior to sham surgery in patients with tendinopathy in
the midterm and long term.
► Tendon loading exercises are as effective as surgery
both in the midterm and long term for patients’ pain,
function and quality of life.
► Surgery should be reserved for selected cases and
only after a sufficiently long course (12 months) of
evidence-based loading exercise has failed.
the healing process.4 The net result is tendon
degeneration, weakness, tearing, and pain.5
As the research on the management of
tendinopathy is constantly increasing, new
treatment modalities continuously emerge
making decisions difficult for the treating
healthcare professionals.6 In the absence
of complete tendon tears, loading remains
the mainstay of treatment and it is recommended as first line for all tendinopathies
for 6 months.7 8 The choice of second-line
treatment, which ranges from non-invasive
modalities such as extracorporeal shock wave
therapy (ESWT), glyceryl trinitrate patches9
and injection therapies to invasive surgery
remains controversial.10 11
Surgery, which may be open or
arthroscopic, is usually reserved for patients
whose symptoms persist despite conservative
management and complete tendon tears;
however, its effectiveness has been repeatedly questioned.6 12 While expert opinion,13 14
guidelines15 16 and systematic reviews17 18 have
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
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eligibility
Included studies had a randomised design and compared
surgery to any mode of non-surgical management for
any type of tendinopathy in terms of at least one of the
following outcomes: ‘pain’, ‘function’, ‘ROM’, ‘force/
strength’, ‘patient satisfaction’, ‘treatment success’,
‘QoL’, ‘complications’. Non-randomised observational
studies, case reports, case series and literature reviews
were excluded. Participants had to be over 18 years of age
with a clinical diagnosis of tendinopathy with or without
radiological signs. Studies including patients with full
tendon tears were excluded. Duration of symptoms/
signs was not a criterion, neither was length of conservative treatment and follow-up. Language criterion was
not applied.
Figure 1 PRISMA flow diagram of included studies.
PRISMA, Preferred Reporting Items for Systematic Reviews
and Meta-Analyses.
attempted to provide guidance to the practising clinician on when surgery may be an appropriate next step
the actual evidence from studies comparing surgical
and non-surgical treatments on tendinopathies remains
limited, and therefore definitive conclusions about the
benefits and ideal timing of surgical intervention are yet
to be reached.
Studies assessing the effectiveness of surgery in orthopaedics have had bias due to the inability for blinding.19 20
In recent years, studies have compared some orthopaedic
operations (including surgery for tendinopathy) with
sham surgery21–23 in a double-blinded manner to mirror
the placebo effect of surgery. In those studies, there
were no differences between control and intervention
groups.21–23
The aim of this systematic review was to consider
evidence that derives from studies assessing the effectiveness of surgery for tendinopathy in the general
population. This includes comparisons of surgery (open
or arthroscopic) with either non-surgical treatment
modalities, sham surgery or no treatment in all tendinopathies with respect to the following outcome measures:
pain, function, range of movement (ROM), force/
strength, patient satisfaction, treatment success, quality
of life (QoL) and complications.
MeThods
The present systematic review has been conducted and
authored according to the ‘Preferred Reporting Items
for Systematic Reviews and Meta-Analyses’24 (PRISMA)
guidelines (figure 1).
2
search strategy
A thorough literature search was conducted by two of
the authors (DC and CC) independently via Medline,
EMBASE, Scopus and CINAHL in March 2018, with
the following Boolean operators: ‘(tendinopathy OR
tendinosis OR tendinitis OR tendonitis OR tennis elbow
OR jumper’s knee OR lateral elbow tendinopathy OR
lateral epicondylitis OR rotator cuff disease OR shoulder
impingement OR patellar OR Achilles) AND (surgery
OR surgical management OR surgical treatment OR
tenotomy OR open surgery OR arthroscopic surgery)
AND (conservative management OR conservative treatment OR physiotherapy OR eccentric exercises OR
eccentric strengthening OR stretching OR shock-wave
therapy OR ESWT OR extracorporeal shock wave therapy
OR ultrasound OR iontophoresis OR laser OR LLLT OR
polidocanol OR sclerotherapy OR botox OR botulinum
toxin OR GTN OR glyceryl trinitrate OR nitroglycerin
OR corticosteroid injections OR platelet rich plasma OR
PRP OR autologous blood OR sham surgery)’.
Medical Subject Heading terms were not used to minimise the risk of missing relevant articles. Review articles
were used to identify eligible articles that were missed at
the initial search. Additionally, reference list screening
and citation tracking in Google Scholar were performed
for each relevant article.
screening
From a total of 874 articles that were initially identified,
after exclusion of duplicate and non-eligible articles, title
and abstract screening and addition of missed studies
identified by review articles, reference list screening and
citation tracking, 12 studies were found to fulfil the eligibility criteria. Figure 1 illustrates the article screening
process according to PRISMA guidelines.24
Quality assessment
For a thorough assessment of the studies, internal validity
(freedom from bias), external validity (generalisability/
applicability) and precision (reproducibility/freedom
from random error) were all assessed separately by two
of the authors (DC and CC) independently and a third
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
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independent opinion (PK) was sought where disagreements existed. Quality scales and resulting scores were
not used as these usually combine aspects of study methodology with aspects of reporting; therefore, they are
thought to be inappropriate for assessment of study
quality.25 In addition, score cut-offs classifying studies of
good or poor quality are usually not provided and consequently these are usually made up by the author of the
review article which can be highly variable.
For internal validity, the ‘Cochrane Collaboration’s
tool for assessing risk of bias in randomised trials’ was
used, which includes six questions/criteria assessing the
risk of five specific and one non-specific (‘other’) types of
bias.25 As ‘other’ bias, our preset assessment criteria were
as follows: (a) adequate and appropriate inclusion and
exclusion criteria, (b) differences between treatment and
control groups at baseline (confounding) and (c) appropriateness of statistical tests deployed. External validity
was assessed based on the population, age range and clinical relevance of interventions and outcome measures.
For the assessment of precision, the sample size, performance of statistical power calculation and p values that
were used to define statistical significance were taken
into account.
In the Cochrane Collaboration’s tool, each item is classified as ‘high’, ‘low’ or ‘unclear’ risk of bias. No total
scores are given. External validity and precision of each
study were rated separately as of ‘high’, ‘low’ or ‘unclear’
risk.
Overall, studies were characterised as of ‘good’,
‘moderate’ or ‘poor’ quality based on a combined
assessment of their internal validity, external validity
and precision which was again conducted by two of the
authors independently (DC and CC) and the opinion of
a third author was provided where the two judgements
differed. The criteria used for overall quality assessment
were as follows: ‘Good’-quality studies had ‘high’ risk
of bias in <2 of the internal validity categories, external
validity and precision; ‘Moderate’-quality studies had
‘high’ risk bias in two of the internal validity categories,
external validity and precision; ‘Poor’-quality studies had
‘high’ risk of bias in >2 of the internal validity categories,
external validity and precision.
data extraction: handling
Each of the eligible articles was initially read by the first
author to gain familiarity and subsequently each article
was re-read and their key characteristics were extracted
and inserted in tables in Microsoft Word to facilitate analysis and presentation.
For the presentation of results, outcomes were
divided into midterm (up to 1-year follow-up) and long
term (more than 1-year follow-up). Where results were
reported at more than one time points in the midterm
and in the long term, the longest-term results were used
for each study in the results tables; however, findings at
all follow-up stages are described in text in the results
section. Where studies used tools and questionnaires as
part of outcome measures, their results were tabulated
under the generic outcome category according to the
aim of the questionnaire. Where results of their specific
subcomponents were presented too, additional results
were tabulated under the corresponding outcome category: for example, where the Oxford Shoulder Score was
used, the aim of which is functional assessment, results
of the overall score were used for ‘function’; if the findings of specific questions of the questionnaires that are
related to ‘pain’ were also described, this specific result
was also used for ‘pain’, etc. The outcome category
‘complications’ included all generic and surgery-specific
intraoperative and postoperative complications as well
as progression of disease to full tendon tears and other
debilitating conditions (eg, adhesive capsulitis).
To classify the strength of evidence for each outcome
reported, we used the rating system formulated by Van
Tulder et al,26 which consists of four levels of evidence:
strong evidence (Level 1) is provided by generally
consistent findings in multiple high-quality randomised
controlled trials (RCTs). Moderate evidence (Level 2)
is provided by generally consistent findings in one highquality RCT and one or more low-quality RCTs, or by
generally consistent findings in multiple low-quality RCTs.
Limited or conflicting evidence (Level 3) is provided by
only 1 RCT (either high or low quality), or by inconsistent findings in multiple RCTs. No evidence (Level 4) is
defined by the absence of RCTs.
As our overall quality assessment included a ‘moderate’-quality category, we extended Level 2 to ‘evidence
provided by generally consistent findings in high-quality
RCT and one or more low-quality or moderate-quality
RCTs or multiple-moderate-quality RCTs’. Two of the
authors (DC and CC) jointly decided on the level of
evidence for each outcome based on the aforementioned
system without any disagreements. Results were considered to be significant when they were based on either
strong or moderate evidence.
definitions and acronyms
Physiotherapy (any tendon rehabilitation regime administered regularly aiming to strengthen the affected tendon
includes ‘supervised exercises’ and ‘eccentric training’;
does NOT include standard postoperative rehabilitation); sham surgery (a faked surgical intervention that
omits the step thought to be therapeutically necessary);
ORI-TETS (the Orthopaedic Research Institute Tennis
Elbow Testing System); OSS (Oxford Shoulder Score);
SDQ (Strengths and Difficulties Questionnaire); HADS
(Hospital Anxiety and Depression Score); VAS (Visual
Analogue Scale); EQ VAS (EuroQoL VAS); EQ-5D-3L
(EuroQoL 5 Dimensions 3 Level index); PRIM (Project
on Research and Intervention in Monotonous work);
QoL (Quality of Life); UCLA (University of California
Los Angeles score); VISA (Victorian Institute of Sport
Assessment); ROM: range of movement; 15D (15-dimensional).
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
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resulTs
A total of 12 eligible studies were identified with a total
of n=1051 participants (mean 87.4±80.9) with n=1056
affected tendons (five bilateral); of these, n=459 tendons
had surgery, n=258 tendons received non-surgical treatments (n=178 physiotherapy, n=50 ESWT, n=30 placebo
laser, n=20 botox, n=10 polidocanol), n=116 had sham
surgery (placebo), n=30 had detuned laser (placebo) and
n=104 had observation only (no treatment). Treatment
was considered to be combined (surgery +physiotherapy)
in three studies, wherein it was specifically stated that the
postoperative physiotherapy was the same as or similar
to the regime administered to the physiotherapy only
group.27–29 Patients treated with surgery in all other
studies followed a standard postoperative rehabilitation
programme. Affected tendons had one of shoulder tendinopathy (n=876), lateral elbow tendinopathy (n=122),
patellar tendinopathy (n=40) or Achilles tendinopathy
(n=20). Of the tendons treated surgically (including
sham surgery), n=177 operations were performed open
and n=398 arthroscopically. Surgery in those with lateral
elbow tendinopathy, Achilles and patellar tendinopathy
was open in all cases while that for shoulder tendinopathy was either open (n=45) or arthroscopic (n=398). A
total of eight studies were controlled as at least one of
their treatment groups received either placebo (detuned
laser or sham surgery) or an exercise regime which has
repeatedly been proven to be effective and is currently
recommended as first-line treatment for all tendinopathies. Mean age was 48.0 years (range 18–72). All studies
included patients with chronic tendinopathy (duration
of symptoms >3 months). Length of follow-up varied
from 6 months to >10 years (median 12 months). Publication years ranged from 1993 to 2018.
Table 1 shows the methodological characteristics and
table 2 presents the summary of samples, interventions
and outcome measures of the included studies.
Quality assessment
Table 3 illustrates our assessment of internal validity,
external validity, precision and overall quality of each
study. Six studies were found to be of ‘poor’ overall
quality, four of ‘moderate’ quality and two of ‘good’
quality.
Internal validity
Selection bias
All 12 studies were randomised. Nine (9) studies were
thought to have ‘low’ risk of bias and one study was
labelled as ‘high’ risk as randomisation was based on
whether reimbursement for ESWT was approved by the
insurance company.30 The randomisation method was not
described in sufficient detail in two studies31 32 (‘unclear’
risk). Risk of bias with regard to allocation concealment
was considered ‘low’ in seven studies wherein either
randomisation was performed by an independent statistician, a centralised telephone randomisation centre or
the authors specifically state that sealed/closed/opaque
4
envelopes were used.22 27 29 31 33–35 The remaining five were
classified as ‘unclear’ risk as details were not provided.
Performance bias
Patients were only blinded in the two studies that
compared surgery with sham surgery.22 34 However, in the
study by Beard et al,34 only the two of the three groups
were blinded. As some patients received no treatment,
the part of the study that compared the surgical groups
to the no treatment group was rated as ‘high’ risk of bias;
the part that compared the two surgical treatments was
‘low’ risk. In the remaining 10 studies, blinding of participants was not possible (surgery vs non-surgical treatment;
‘high’ risk).
Detection bias
Blinding of outcome measures was thought to be sufficient (‘low’ risk) in studies wherein attempts were made
to blind the assessors by (a) using independent assessors,
(b) asking the participants not to disclose the nature of
their treatment to assessors and to (c) wear t-shirts to
hide surgical scars were applicable.22 28 29 34 36 37 All other
studies (n=6) were labelled as ‘high risk’.
Attrition bias
Reasons for dropouts/withdrawals of participants were
adequately reported in all studies (‘low’ risk) but one37
(‘high’ risk). Rate of follow-up completion was considered of ‘high’ risk in the study by Farfaras et al,28 where
it was only 63%. In the study by Kroslak & Murrell,22
follow-up completion rate was 85% for the self-rated
outcomes but only 42% for the clinical tests; however,
the study was rated as ‘low’ risk of bias as the primary
outcome measure was self-rated (frequency of elbow pain
during activity at 6 months).
Reporting bias
Reporting of results was found to be inappropriate or
inadequate in five studies (‘high’ risk); Alfredson et al,33
Rahme et al37 and Ketola et al29 only included self-reported parameters in their outcome measures and
additionally the first two studies only included VAS for
pain (Rahme et al37) or VAS for pain and satisfaction
(Alfredson et al33). Keizer et al32 used categorical variables
in their analysis with an inappropriately small number of
categories in some cases; for example, ROM was classified
as either ‘normal’ or ‘limited (>5 degrees)’. Additionally,
Alfredson et al33 did not include any graphical or tabular
representation of their results. Brox et al36 and Alfredson
et al33 did not present details, statistical comparisons or
p values for some of their findings. The remaining six
studies were rated as ‘low’ risk.
Other bias
Inclusion and exclusion criteria were thought to be
adequate for all but two studies: Alfredson et al33 did not
mention any eligibility criteria at all and the exclusion
criteria of Rahme et al37 was limited to ‘glenohumeral
osteoarthritis and those requiring resection of the lateral
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
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Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
Table 1 Methodological characteristics of included studies
First author—
tendinopathy
Study type
Randomisation method
Blinding method
Allocation
concealment
Statistical power Baseline
calculation
comparison
Brox36—
Shoulder
Randomised
controlled trial
Random permuted
blocks
Patients wearing
–
t-shirts at followup to hide scar;
patients asked not
to talk to assessor
about treatment
Yes, 90%
Rahme37
—Shoulder
Randomised
controlled trial
Blocked
randomisation
Independent
assessor
–
Rompe30—
Shoulder
Randomised trial
(non-controlled)
Based on whether
reimbursement for
ESWT was approved
by insurance
company
Not blinded
Haahr35—
Shoulder
Randomised
controlled trial
Computer-generated
random sequence
generation
Not blinded
Follow-up
completion
Inclusion criteria
Exclusion criteria
Less women in
surgery group
Age 18–66 y, shoulder pain for
>3 m, resistant to physio and
drugs, dysfunction/pain on
abduction, normal passive ROM,
pain during two of the three
isometric-eccentric tests, positive
impingement tests
Acromioclavicular joint arthritis,
99%
cervical syndrome, rotator cuff
rupture, glenohumeral instability,
bilateral muscular pain with
tenderness and severely decreased
ability to relax the shoulder/
neck/temporomandibular joint on
examination, reluctant to accept one
or more of the treatment regimens of
the study
No
No comparison
Isolated shoulder disease,
Glenohumeral osteoarthritis, those
working age, shoulder pain >1 y at requiring resection of the lateral end
rest accentuated by movements
of the clavicle
involving elevation, positive
Hawkins (impingement) sign,
positive impingement test (relief
of symptoms within 15 min of
injection of local anaesthetic)
–
–
No differences
Calcareous deposit on standard
AP radiographs of a diameter of
at least 10 mm; the morphological
features of the deposit had to
be homogeneous in appearance
and with well-defined borders, or
inhomogeneous in structure with
sharp outline or homogeneous in
structure with no defined border,
shoulder pain for more than 12
m, clinical signs of subacromial
impingement, unsuccessful
conservative therapy in the
previous 6 m, no evidence of
bone-related anatomic outlet
impingement or functional
outlet impingement as seen on
radiographs or MRI
Cloudy and transparent appearance 75%
of deposit, radiological signs of
spontaneous resorption, evidence
of type III acromial morphological
feature according to Bigliani et al
on the outlet view of the acromion,
evidence of subacute acromial
bursitis, evidence of acromial spur
or acromioclavicular osteophytes
on AP radiographs, evidence of
rotator cuff tears on MRI, evidence
of functional impingement of rotator
cuff on USS or arthroMRI, tears
of the glenohumeral ligaments
of the labrum, hypertrophy of
supraspinatus muscle, dysfunction
in neck or thoracic region, prior
shoulder surgery, local degenerative
disease of shoulder, RA, neurological
abnormalities of the upper limb with
calcifying tendinitis, pregnancy,
infection, tumour
Sealed
envelopes
Yes, 80%
More sick leave
due to more
severe shoulder
pain in surgery
group
Fulfilment of all diagnostic criteria
(shoulder pain, pain on abduction
with painful arc, Hawkins sign,
positive impingement test (relief
of symptoms within 15 min of
injection of local anaesthetic),
symptoms 6 m–-3 y, age 18–55
y, normal passive glenohumeeal
movements
Impaired glenohumeral rotation,
93%
history of acute trauma, previous
surgery of fracture near affected
shoulder, known OA in glenohumeral
or acromioclavicular joint,
clacifications >2 cm in rotator cuff
tendons, rupture of the cuff, cervical
root syndromes
93%
Open access
Continued
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Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
First author—
tendinopathy
Study type
Randomisation method
Blinding method
Allocation
concealment
Statistical power Baseline
calculation
comparison
Ketola29 —
Shoulder
Randomised
controlled trial
Computer-generated
numbers
Independent
physiotherapist
conducted 5-year
assessment;
participants
wearing t-shirts
to cover scars
and asked not to
indicate treatment
group
Randomisation Yes, 80%
by independent
statistician;
sealed
envelopes
Farfaras28—
Shoulder
Randomised
controlled trial
Envelopes divided in
boxes based on sex
and age
Independent
physiotherapist
conducted
assessment;
participants
encouraged to
wear a t-shirt
at follow-up to
conceal their scar
–
Beard34—
Shoulder
Randomised
controlled trial
Automated
computer-generated
minimisation system
Double blinded
except ‘no
treatment’ group;
masked
assessment
Bahr27—
Patella
Randomised
controlled trial
Randomisation
sequence in blocks
of four created
by statistician;
those who had
failed eccentric
strengthening
were allocated to
secondary surgery
group
Alfredson33—
Achilles
Randomised trial
(non-controlled)
Box with envelopes
Follow-up
completion
Inclusion criteria
Exclusion criteria
No difference
in outcome
measures, no
comparison of
demographics
Clinical symptoms of shoulder
impingement, positive Neer’s test,
symptoms for at least 3 m, failed
management with rest, NSAIDs,
steroid injections and regular
physiotherapy, age 18–60 y, no
previous shoulder operations,
willingness and capacity to
comply with study protocol
OA, glenohumeral instability,
penetrating rotator cuff rupture,
cervical radiculopathy, adhesive
capsulitis, shoulder neuropathy
Yes, sample
size not
enough for
80% power
No difference
Positive Neer and Hawkins tests,
failed conservative management,
subacromial pain for more than
6m
Diabetes mellitus, neurological or
63%
spine disorders, radiographic OA,
chronic joint disorders, full-thickness
rotator cuff tear, subacromial
impingement syndrome stage 3
Centralised
telephone
randomisation
centre used
Yes, 90%
No difference
Subacromial pain for at least 3
m, consultant’s clinical diagnosis,
eligible for arthroscopic surgery,
completion of conservative
management programme
including physiotherapy and at
least one steroid injection
Full-thickness rotator cuff tear,
other shoulder pathology identified
on MRI or USS, previous shoulder
surgery on affected side, RA or
other inflammatory joint conditions,
cervical spine pathology, previous
septic arthritis in shoulder,
radiotherapy in same side as
affected shoulder, lacking consent,
cognitive impairment or language
issues, unable to perform clinical
assessments, >75 y of age
81%
Not blinded
Sealed
envelopes;
randomisation
sequence
created by
statistician
Yes, 90%
No differences
History of exercise-related pain
in proximal patellar tendon or
patellar insertion and tenderness
to palpation, pain during and after
activity and unable to participate
in sports at same level as before
onset of pain, thickening and
increased signal intensity on MRI
History of knee/patellar tendon
surgery, inflammatory or
degenerative joint condition,
less than 18 y of age, inability
to understand oral and written
Norwegian
88%
Not blinded
Opaque
envelopes
No
No comparison
as information
not provided
–
–
95%
Open access
Table 1 Continued
78%
Continued
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Yes, 90% but
not enough
participant
recruited
Sealed,
unmarked
envelopes
Double blinded
Computer-generated
code
Randomised
controlled trial
Kroslak22—
Lateral elbow
AP, antero-posterior; ESWT, extracorporeal shock wave therapy; m, months; MRI; magnetic resonance imaging; NSAIDs, non-steroidal anti-inflammatory drugs; OA, osteoarthritis; RA, rheumatoid arthritis; ROM, range of movement; USS,
ultrasound scan; w, weeks; y, years.
Previous surgery or dislocation of
affected elbow, steroid injection in
last 3 m, inadequate skin coverage
over elbow, sensory/motor changes
distal to elbow, unwillingness/
inability to attend follow-up or enter
either treatment arm
>18 y of age, clinical diagnosis
lateral epicondylitis (point
tenderness over lateral epicondyle
and worse pain with chair pickup test and maximal hand grip),
failed conservative therapy for 6
m (including injections)
85%
(42% for
clinical
assessment)
Younger than 18 y, local infection,
89%
malignancy, elbow arthritis,
generalised polyarthritis, ipsilateral
shoulder dysfunction, neurological
abnormalities, radial nerve
entrapment, cardiac arrhythmia,
pacemaker, steroid injection last 6 w,
pregnancy
Established diagnosis of lateral
epicondylitis with failure of
conservative Tx for 6 m (NSAIDs,
steroid injections, physical
therapy, exercise programme,
elbow brace)
Pain induced by >1 of palpation of
lateral epicondyle, resisted wrist
extension, chair test
Characteristics
of two groups
presented but
comparison not
performed
Yes, 80%
Closed
envelopes
Not blinded
Randomised trial
(non-controlled)
Radwan31—
Lateral elbow
Closed envelopes
Follow-up
completion
Exclusion criteria
Inclusion criteria
Statistical power Baseline
calculation
comparison
Allocation
concealment
Blinding method
Randomisation method
Study type
First author—
tendinopathy
Table 1 Continued
end of the clavicle’. Baseline characteristics of the treatment control groups were presented by all but two studies
(‘high’ risk; Alfredson et al33 and Rahme et al37). Of the
remaining 10 studies, one did not perform statistical
analyses comparing the two groups at baseline (‘unclear’
risk; Radwan et al38), one only compared outcome
measures and not demographics (‘unclear’ risk; Ketola
et al29). Eight (8) studies performed adequate baseline
comparisons; five of them reported no differences in
demographics or outcome measures between treatment
groups (‘low’ risk; Bahr et al,27 Beard et al,34 Farfaras et
al,28 Kroslak & Murrell,22 Rompe et al30) and the other
three found trivial differences that were regarded as
introducing ‘low’ risk of bias (Brox et al,36 Haahr et al35
and Keizer et al32 (table 1). The risk of ‘other’ bias in
the study by Keizer et al32 was classified as ‘high’ as some
of the patients in their botox group received a second
injection at 6 weeks follow-up and some others ended up
having surgery. Appropriate statistical tests and comparisons were deployed in all studies except for Rahme et al37
who utilised a ‘as treated’ and not a ‘intention-to-treat’
basis when comparing groups at 12 months, although
the authors themselves acknowledge this limitation in
the manuscript.
external validity
General, non-specific populations were used in all
studies. Age ranges of participants were wide enough
to allow for good generalisability in all studies. Clinically relevant assessment tools and outcome measures
were used in nine studies. Alfredson et al33 and Rahme
et al37 only included self-reported pain and satisfaction,
whereas Ketola et al29 used a much greater number of
measures, all of which were, however, also self-reported
(‘high’ risk). The nature, frequency and intensity of
physiotherapy that were considered appropriate were
used, and no guidelines exist about the best formulation
or dosage of the other non-surgical treatments (botox,
polidocanol and ESWT) in clinical practice; therefore,
all doses and frequencies used were considered clinically
relevant (‘low’ risk).
Precision
Statistical power calculation prior to recruitment was
performed in all but three studies (Alfredson et al,33
Keizer et al32 and Rompe et al30). The studies by Alfredson
et al33 and Keizer et al32 had small sample sizes (n=20 and
n=40, respectively) in addition to their failure to perform
statistical power calculation; therefore, they were rated as
‘high’ risk of bias. The study by Rompe et al30 was classified as ‘unclear’ risk as its much larger sample size (n=79)
is comparable to studies that recruited to a power of at
least 80%. Where a power calculation was performed,
sample sizes were adequate for a power of at least 80%
except for the study by Farfaras et al28 (‘high’ risk). Levels
of significance were set at p=0.05 in all studies except for
that of Alfredson et al33 where the level of significance is
not stated.
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
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Open access
8
Tendon
affected
Sample,
Min
mean/median
duration of age (range),
symptoms %F
Interventions
Supervision?
(physio only) Follow-up
Rotator cuff
3m
N=125; mean Arthroscopic surgery
48 y (18–66 y); (n=45) or
47%
physiotherapy (n=50) or
detuned laser (placebo)
(n=30)
Yes, 3–6 m
Rahme37
Rotator cuff
12 m
N=42; mean
Open surgery (n=21)
42 y (28–63 y); or
55%
physiotherapy (n=21)
Yes, not stated 6 m, 12 m
Rompe30
Rotator cuff
12 m
N=79; mean
50.8 y (31–68
y); 61%
ESWT 3000 impulses, 0.6
mJ/mm2(n=50) or
open surgery (n=29)
Haahr35
Hahr (2009)
Rotator cuff
6m
N=90; mean
44.4 y(; 69%
Arthroscopic surgery
(n=45)
or
physiotherapy (n=45)
Yes, 12 w
Ketola29
Rotator cuff
3m
N=140; mean
47.1 y (23–60
y); 63%
Arthroscopic surgery
+physiotherapy (n=70)
or
physiotherapy (n=70)
Rotator cuff
Farfaras28,
Farfaras (2018)
6m
N=87; mean
Arthroscopic surgery
49.3 y (41–78); +physiotherapy (n=29)
51%
or
open surgery
+physiotherapy (n=24)
or
physiotherapy (n=34)
Yes, mean 6.5 3 m, 6 m,
(a) VAS for pain (0–10; primary measure), (b) VAS
visits
12 m, 24 m, for disability (0–10), (c) VAS for working ability
60 m
(0–10), (d) VAS for pain at night (0–10), (e) SDQ
score, (f) number of painful days in previous 3 m, (g)
proportion of pain-free patients (VAS for pain <4), (h)
health-related QoL (15-day tool) at 5 y
Yes, 3–6 m
2.5 y, >10 y (a) Constant score (0–100; includes VAS for pain,
limitations in ADLs, active ROM of glenohumeral
joint in four directions, isometric shoulder strength
measurement), (b) SF-36 (general health), (c) Watson
& Sonnabend score (0–3, 14 questions), (d) ROM
active elevation and internal rotation, (e) abduction
strength, (f) USS and X-ray both shoulders
First author
Brox
36
3 m, 6 m,
2.5 y
12 m, 24 m
Outcome measures
(a) Neer shoulder score (pain during previous week
0–35, function tests (muscle tests, reaching ability,
stability 0–30 and active ROM 0–25), anatomical/
radiological evaluation 0–10), (b) pain at rest, at
night, during activity during previous week (1–9), (c)
emotional distress with Hopkins symptom checklist
(0–25), (d) costs
(a) VAS for pain at rest plus VAS for pain during
‘pour out of pot’ manoeuvre (treatment success if
>50% improvement compared with baseline)
Open access
Table 2 Description of samples, interventions and outcome measures
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
(a) UCLA rating for pain and function of the shoulder
(Kay and Amstutz): max score 35 points; pain 1–10,
function 1–10, active range forward flexion 0–5,
strength in forward flexion 0–5, patient satisfaction
0–5, (b) Outcomes score (>33 excellent, 29–33
good,<29 poor), (c) radiological evaluation: AP
radiograph 1 day before surgery or ESWT and at 12
m; resorption graded as none, partial or complete
3 m, 6 m, 12 (a) Constant score (primary outcome; 0–100;
m, >4 y
includes VAS for pain, limitations in ADLs, active
ROM of glenohumeral joint in four directions,
isometric shoulder strength measurement), (b) Likert
scale (0–9, numerical box complaint scale), (c)
employment within last 3 m, (d) sick leave, (e) labour
compensation claims
Continued
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Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
Table 2 Continued
Tendon
affected
Sample,
Min
mean/median
duration of age (range),
symptoms %F
Interventions
Rotator cuff
3m
N=313; mean
53 y 50%
Arthroscopic surgery
(n=106)
or
sham surgery (n=103)
or
no treatment (n=104)
Bahr27
Patellar
3m
N=35 (40
tendons);
mean 31 y (19–
49 y); 14%
Open surgery
+physiotherapy (n=20
tendons) or
physiotherapy (n=20
tendons)
Alfredson33
Achilles
6m
Radwan31
Wrist
extensors
Kroslak22
Wrist
extensors
First author
Beard
34
Supervision?
(physio only) Follow-up
Outcome measures
6 m, 12 m
(a) OSS (primary outcome; 0–48), (b) modified
Constant-Murley Shoulder Score (for function
and ROM), (c) Pain DETECT (questionnaire for
neuropathic pain), (d) Quantitative sensory testing,
(e) adverse events, (f) QoL life (EQ-5D-3L), (g)
EQ VAS, (h) treatment expectations, (i) patient
perception or satisfaction, (j) anxiety and depression
(HADS score).
3 m, 6 m,
12 m
(a) VISA score (0–100), (b) global evaluation score
(−5 to +5), (c) treatment satisfaction (4-grade scale),
(d) functional tests (standing jumps, countermovement jumps and leg extension strength), (e)
VAS score for pain after each functional test (0–10)
N=20; mean 46 Open surgery (n=10) or
y ; 55%
polidocanol injection
(n=10)
12 w, 6 m
(a) VAS for pain (0–100) during activity, (b) patient
satisfaction (satisfied or not satisfied)
6m
N=56; mean
ESWT 1800 impulses,
40 y (22–60 y); 0.22 mJ/mm2 (n=29) or
41%
open surgery (n=27)
3 w, 6 w, 12
w, 1 y
6m
N=26 mean
51.5 y (41–77
y); 68%
Open surgery (n=13)
or
sham surgery (n=13)
Yes, 12 w
ADLs, activities of daily living; AP, antero-posterior; EQ-5D-3L, EuroQoL 5 Dimensions 3 Level index; ESWT, extracorporeal shock wave therapy; HADS, Hospital Anxiety and Depression
Score; ORI-TETS, Orthopaedic Research Institute Tennis Elbow Testing System; OSS, Oxford Shoulder Score; QoL, quality of life; ROM, range of movement; SDQ, Strengths and Difficulties
Questionnaire; SF-36, Short Form Health Survey; UCLA, University of California Los Angeles score; USS, ultrasound scan; VAS, Visual Analogue Scale; VISA, Victorian Institute of Sport
Assessment; m, months; w, weeks; y, years.
Open access
(a) Pain (at night, at rest) with VAS score (0–100),
(b) residual pain at 12 m based on criteria by Roles
& Maudsley (excellent, good, acceptable, poor), (c)
tenderness with VAS score (0–100), (d) grip strength
(scale 1–4), (e) treatment success: asymptomatic at
15 days
2 w, 6 w, 12 (a) Pain (frequency and severity) with Likert-based
w, 26 w, >1 y verbal descriptor scale with activity, at rest and
during sleep, (b) Self-rated function (picking up
objects, twisting motions, elbow stiffness, overall
elbow rating), (c) point tenderness (Likert verbal
descriptor pain scale), (d) elbow stiffness and
ROM, (e) Maximal force of wrist extension during
chair pick-up test using ORI-TETS, (f) maximal grip
strength
9
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10
Table 3 Quality assessment of included studies
Internal validity
(Cochrane’s collaboration tool for assessing risk of bias)
Selection bias
Performance
bias
Detection bias
Attrition bias
Reporting
bias
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
Random
sequence
First author generation
Allocation
concealment
Blinding of
patients and
staff
Blinding of
outcome
measures
Completeness Selective
of outcome data reporting
External
Other Validity
Overall
Precision quality
Brox36
Rahme37
Low
Low
?
?
High
High
Low
Low
Low
High
High
High
Low
High
Low
High
Low
Low
Rompe30
High
?
High
High
Low
Low
Low
Low
?
Poor
Keizer32
?
?
High
High
Low
High
High
Low
High
Poor
Haahr35
Low
Low
High
High
Low
Low
Low
Low
Low
Moderate
Bahr27
Low
Low
High
High
Low
Low
Low
Low
Low
Moderate
Low
Low
High
High
Low
High
High
High
High
Poor
Alfredson
Radwan
33
31
Ketola29
28
Moderate
Poor
?
Low
High
High
Low
Low
?
Low
Low
Moderate
Low
Low
High
Low
Low
High
?
High
Low
Poor
Low
?
High
Low
High
Low
Low
Low
High
Poor
Beard34
Low
Low
Low
Low
Low
Low
Low
Low
Good
Kroslak22
Low
Low
Low
High
Low
Low
Low
Low
Low
Low
High
Good
Farfaras
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Findings of included studies
Tables 4a and b provide a summary of midterm (up to
1-year follow-up) and long-term (>1-year follow-up)
results along with levels of evidence for the overall results
of each outcome measure.
Surgery versus no treatment/placebo
One good-quality study compared surgery with no treatment for shoulder tendinopathy. In the study by Beard
et al,34 at 6-month and 12-month follow-up, the two
surgical groups (corrective surgery and sham surgery)
had a higher OSS than the no treatment group at statistical significance. A similar pattern was observed in the
secondary outcomes, all of which had improved at 6
months in the corrective surgery group compared with
the no treatment group. The modified Constant-Murley
and HADS were statistically in favour of the sham surgery
group compared with no treatment. At 12 months, the
only significant difference was observed in the modified Constant-Murley score, which was higher in the two
surgical groups compared with the no treatment group.
Equally, patient satisfaction at 6 months was statistically
higher in the two surgical groups versus the no treatment
group; only some of the parameters were statistically
significant at 12 months in favour of the surgical groups.
Surgery versus placebo (other than sham surgery)
One moderate-quality study compared surgery with
placebo in patients with shoulder tendinopathy. Brox et
al36 found that the detuned laser (placebo) group had
a lower mean improvement in the Neer score and all its
subcomponents compared with the two other treatment
groups at 6 months and at this point the authors decided
not to allocate more patients to the placebo group as it
appeared to be inferior. Treatment success at 2.5-year
follow-up was also in favour of the surgical group versus
no treatment at statistical significance.
Surgery versus sham surgery
Two good-quality studies compared surgery with sham
surgery. Kroslak & Murrell22 reported no statistically
significant differences between the two groups in
perceived pain, function and recovery at 6-month and
>12-month follow-up. Both groups exhibited statistically
significant improvements in self-rated pain frequency
and severity, elbow stiffness and difficulty picking up
objects at 6-month and >12-month follow-up as well as
epicondyle tenderness, pronation-supination range, grip
strength and modified ORI-TETS at 6-month follow-up
compared with baseline. In the study by Beard et al34 at
6-month and 12-month follow-up, the two surgical groups
(corrective surgery and sham surgery) had statistically
higher OSS than the no treatment group.
Surgery versus physiotherapy
A total of six studies compared surgery with physiotherapy
in shoulder tendinopathy (n=5) and patellar tendinopathy (n=1). Three of them were of moderate and three of
poor overall quality. Brox et al36 were the first to compare
surgery and any mode of conservative management with
a randomised study in patients with shoulder tendinopathy. Comparing arthroscopic surgery and physiotherapy,
there was a statistically insignificant difference in the Neer
score improvement and pain reduction from moderate
to mild favouring the surgical group. The latter outcome
measure was found to be statistically significant when
the comparisons were adjusted for sex (fewer females in
the surgical group at baseline) in favour of the surgical
group. At 2.5-year follow-up, success rates (defined as
Neer score >80) were similar between those who received
exercises only and those who received surgery.
In a similar study in patients with shoulder tendinopathy, Haahr et al35 reported no differences in Constant
score (primary outcome) and its sub-scores (pain, function, ROM, force) between their two groups over 1
year. Differences in the secondary outcomes (pain and
dysfunction) were also non-significant at 1-year follow-up.
Six of the patients in the physiotherapy group (14%)
ended up having an operation within the 12 months;
comparisons at 12 months were performed as per ‘intention-to-treat’ which may have resulted in results being
biassed in favour of the physiotherapy group. The same
group38 later found no significant differences between
the two groups in terms of income transfers, obtaining a
disability pension 4 years after inclusion and self-reported
outcomes as measured by the PRIM score 4–8 years after
inclusion.
Rahme et al,37 in their study of shoulder tendinopathy,
investigated surgical patients receiving postoperative
physiotherapy, the nature or further details of which
are not reported; therefore, we do not consider this as
combined treatment. Even though the emphasis of the
study was on predictive factors and pain-generating mechanisms, at 6-month follow-up there was no difference in
the two groups with regard to the proportion who had
achieved at least 50% reduction of the initial total pain
score. After the 6-month time point, more than half of
the physiotherapy group were given the opportunity and
elected to have surgery and results at 12-month follow-up
are presented on an ‘as treated’ and not on an ‘intentionto-treat’ basis.
In their study, Ketola et al29 found no differences
between patients with shoulder tendinopathy receiving
physiotherapy versus those receiving physiotherapy plus
surgery in the primary (self-rated pain) or secondary
(disability, night pain, SDQ score, number of painful
days, proportion of pain-free patients) outcomes at 2- and
5-year follow-up. Both groups demonstrated statistically
significant differences in all outcome measures at 5-year
follow-up compared with baseline.
In another shoulder tendinopathy study by Farfaras
et al,28 both surgical groups (open and arthroscopic)
received the same physiotherapy regime as the physiotherapy only group postoperatively. Compared with
baseline, none of the three treatment groups demonstrated significant differences in the overall SF-36 score
at follow-up (mean 31 months) with no intergroup
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Mid-term results (<1-year follow-up)
Treatment modes
Surgery versus detuned laser or no treatment
Tendon affected
First author (year)
36
Rotator cuff
Brox
Rotator cuff
Beard34
ROM
Strength
Satisfaction
QoL
Complications
↓
↑
↑
–
–
↑
–
↔
↓
↑
↑
–
↑
↑
↑
↔
↔ (2)
↓ (2)
↑ (2)
↑ (2)
– (4)
↑ (3)
↑ (2)
↑ (3)
Beard34
↔
↔
↔
–
↔
↔
↔
↔
Wrist extensors
Kroslak22
↔
↔
↔
↔
–
–
–
↔
↔ (2)
↔ (2)
↔ (2)
↔ (3)
↔ (3)
↔ (3)
↔ (3)
↔ (2)
↔
↔
↔
–
–
–
–
–
–
–
–
–
–
–
–
Overall surgery versus sham surgery (evidence level)
Surgery versus physiotherapy
Function
Rotator cuff
Overall surgery versus detuned laser or no treatment (evidence level)
Surgery versus sham surgery
Treatment
Success
Pain
Rotator cuff
Brox36
Rotator cuff
Rahme37
↔
–
Rotator cuff
Haahr35
↔
↔
↔
↔
–
–
–
Patellar
Bahr27
↔
↔
–
↔
↔
↔
–
–
↔ (2)
↔ (2)
↔ (2)
↔ (2)
↔ (3)
↔ (3)
– (4)
– (4)
Overall surgery versus physiotherapy (evidence level)
Challoumas D, et al. BMJ Open Sport Exerc Med 2019;5:e000528. doi:10.1136/bmjsem-2019-000528
Surgery versus ESWT (evidence level)
Rotator cuff
Rompe30
↔ (3)
– (4)
– (4)
– (4)
– (4)
↔ (3)
– (4)
– (4)
Surgery versus botox (evidence level)
Wrist extensors
Keizer32
↔ (3)
– (4)
↔ (3)
↔ (3)
– (4)
↔ (3)
– (4)
– (4)
Surgery versus polidocanol (evidence level)
Achilles
Alfredson33
↔ (3)
– (4)
– (4)
– (4)
↔ (3)
– (4)
– (4)
– (4)
Open access
12
Table 4a
up arrow = increased; down arrow = decreased; side arrow = no changes
ESWT, extracorporeal shock wave therapy; QoL, quality of life.
Table 4b Long-term results (>1-year follow-up)
Treatment modes
Tendon affected
First author (year)
36
Surgery versus detuned laser or no treatment (evidence
level)
Rotator cuff
Brox
Surgery versus sham surgery (evidence level)
Wrist extensors
Kroslak22
Surgery versus physiotherapy
Rotator cuff
Brox36
29
ROM
Force
Satisfaction
Treatment
Success
QoL
Complications
– (4)
– (4)
– (4)
– (4)
– (4)
↑ (3)
– (4)
– (4)
↔ (3)
↔ (3)
↔ (3)
– (4)
– (4)
– (4)
↔ (3)
–
–
–
–
–
↔
–
–
↔ (3)
Rotator cuff
Ketola
↔
–
–
–
–
↔
↔
Haahr35 ; Haahr38
↔
↔
–
–
–
↔
–
Rotator cuff
Farfaras28
–
↔ (2)
Rotator cuff
Wrist extensors
Rompe30
Radwan
Overall surgery versus ESWT (evidence level)
Surgery versus botox (evidence level)
Function
Rotator cuff
Overall surgery versus physiotherapy (evidence level)
Surgery versus ESWT
Pain
Wrist extensors
Keizer32
31
↔
–
↑
↑
↔
–
↔
↔
↔
↑ (3)
↑ (3)
↔ (3)
- (4)
↔ (2)
↔ (2)
↔ (3)
–
–
–
–
↑
↔
–
–
↔
–
↔
–
–
↔ (2)
– (4)
– (4)
↔ (3)
– (4)
↑ (3)
– (4)
– (4)
↔ (3)
↔ (3)
– (4)
↔ (3)
– (4)
– (4)
↔ (3)
– (4)
Significant results (strong or moderate evidence) are highlighted in bold. Strong evidence (Level 1) is provided by generally consistent findings in multiple high-quality RCTs. Moderate evidence (Level 2) is provided by generally consistent findings
in one high-quality RCT and one or more low-quality RCTs, or by generally consistent findings in multiple low-quality or moderate-quality RCTs. Limited or conflicting evidence (Level 3) is provided by only one RCT (either high or low quality), or by
inconsistent findings in multiple RCTs. No evidence (Level 4) is defined by the absence of RCTs (van Tulder et al26, 2003).
ESWT, extracorporeal shock wave therapy; RCTs, randomised controlled trials.
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differences. All three groups improved significantly in
terms of internal rotation at follow-up versus baseline
with no significant difference between groups. The
Constant score improved at statistical significance from
baseline to follow-up in the two surgical groups but not
in the physiotherapy group; however, no significant
intergroup differences were observed. Active elevation
strength only improved significantly in the open surgery
group at follow-up compared with baseline but, similarly,
the three groups were statistically similar at follow-up.
The same group reported results of the same patients
at >10-year follow-up which favour surgery over physiotherapy. The surgical groups demonstrated significantly
improved active elevation ROM compared with the
physiotherapy group, internal rotation improved within
all groups from baseline to follow-up but not between
groups and muscle strength only improved significantly
at follow-up within the open surgery group without intergroup differences.
In the study by Bahr et al27 in patellar tendinopathy,
VISA score improved significantly in both groups with
time; however, there was no statistically significant differences between the groups at any stage of follow-up.
Similarly, there were improvements in the leg-press
strength test with time in both groups but no intergroup
differences. Jump height did not change in either group
at any stage of follow-up compared with baseline and the
two groups were statistically similar. Compared with baseline, pain scores during functional tests improved at 12
months but not 6 months in both groups and there were
no differences between groups. Equally, there was no
difference in overall treatment satisfaction or return to
sports between groups at 12 months. Finally, with respect
to the global evaluation score, the eccentric group
demonstrated improved outcomes at statistical significance compared with the surgical group at 3 months;
however, the two groups were statistically similar at 6 and
12 months.
Surgery versus ESWT
One poor-quality study and one moderate-quality study
compared the effectiveness of (open) surgery versus
ESWT in chronic tendinopathy. Rompe et al30 tested the
two modalities in patients with shoulder tendinopathy
and reported improved clinical outcome in terms of the
UCLA score in the surgical group versus the ESWT group
at 24 months follow-up. Self-rated pain reduction at
24-month follow-up was similar between the two groups.
Finally, hospital stay and absence from work were significantly shorter in the ESWT group.
In the study by Radwan et al,31 patients with lateral
elbow tendinopathy treated surgically exhibited no
significant differences in any of the outcome measures
compared with those receiving ESWT at any of the
follow-up stages. Significant improvements with time
were observed in all outcome measures in both treatment groups.
Surgery versus botox
One poor-quality study compared surgery with botox injections in chronic lateral elbow tendinopathy.32 In terms of
overall results and pain, the two treatment groups were
statistically comparable at all follow-up stages. Compared
with the botox group, the surgical group exhibited a
greater extension deficit at 3 and 6 months but the difference had disappeared at 12 and 24 months. Sick leave
was significantly shorter in the surgical group versus the
botox group at 3 months; however, no statistically significant longer-term differences were observed.
Surgery versus polidocanol
One poor-quality study allocated patients with Achilles
tendinopathy to either surgery (colour Doppler-guided)
or polidocanol injections.33 At 12-week follow-up, 67%
of the patients in the polidocanol group and 80%
of those in the surgical group were satisfied with the
results and returned to their pre-injury recreational/
sport activity (statistical comparison not presented).
Pain scores reduced at statistical significance in both
groups compared with baseline and even though no
between-group statistical comparisons are presented,
pain improvement at 12 weeks appears to be similar in
the two groups (VAS scores 76 to 24 in polidocanol group
and 75 to 21 in surgical group). At 6 months, 100% of
the surgical group versus 67% of the polidocanol group
were satisfied with treatment and returned back to their
pre-injury recreational/sport activities; again, no statistical comparisons are reported.
dIsCussIon
We found no evidence for superiority of surgery to
exercise-based therapies in patients with tendinopathy.
To our knowledge, this is the first systematic review
comparing surgery with no treatment, sham surgery and
exercise-based therapies modalities in all tendinopathies.
Some studies advocate surgery for tendinopathies after
3–6 months of conservative management.27 36 Our analysis demonstrates that outcomes after tendon loading
exercises both up to 12 months and longer term are as
good as surgery, at least for shoulder tendinopathy. An
interesting finding of our review is that surgery appeared
to be superior to no treatment or placebo but not to sham
surgery. While the placebo group that received detuned
laser in the study by Brox et al36 exhibited no improvement in the Neer shoulder score at 6-months follow-up,
the group of patients that received no treatment in the
study by Beard et al34 had a higher OSS at both 6 and 12
months compared with baseline.
This discrepancy may be a result of different outcome
measures and/or sample sizes in the two studies or
other methodological differences. Regardless of this
discrepancy, surgery was significantly more effective than
detuned laser and no treatment in the two studies but not
to sham surgery in the latter study. This is in accordance
with the findings of Kroslak & Murrell22 who found no
differences in outcomes with the Nirschl procedure versus
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sham surgery in patients with lateral elbow tendinopathy.
According to Beard et al,34 the difference between surgery
and no treatment, taking into account the similar effects
of arthroscopic decompression and sham arthroscopy,
may be attributable to surgical placebo effect, unidentified effects of arthroscopic assessment of the joint and
bursa, and rest and postoperative physiotherapy associated with surgery. Based on their findings, the authors
state that arthroscopy (with or without decompression)
could be used for the treatment of shoulder tendinopathy but at the same time they suggest assessing other
management strategies apart from surgery.
Sham surgery in randomised controlled surgical trials
is gaining increasing popularity despite ethical considerations and studies with sham surgery in orthopaedics
have reported interesting results.23 39 Compared with
using a non-surgical control group, sham surgery equalises the placebo effect of surgery and can give more
realistic insights into the effectiveness of the actual
surgical procedure in question.40 In their recent systematic review of sham surgery in orthopaedics, Louw et al41
included six studies comparing orthopaedic procedures
with sham surgery, one of which was the study by Kroslak
& Murrell22 included in the present review. The authors
concluded that sham surgery appears to be as effective
as corrective surgery in terms of pain and disability for
certain conditions; however, the results are not necessarily generalisable to operations not included in the
review. This is in accordance to our study, which additionally showed similar outcomes of sham and corrective
surgery in function and ROM in shoulder tendinopathy
and lateral elbow tendinopathy. The exact mechanisms
of surgery (corrective or sham) leading to improvement
of outcomes in tendinopathy remain uncertain and the
possibility of this improvement being due to the postoperative tendon rehabilitation cannot be ignored.
Despite the rigour of our review with respect to identifying all the available evidence and the quality assessment
of the included studies, we recognise study limitations.
First, due to the small number of eligible studies and the
different comparisons of surgery with each non-surgical
treatment modality, our conclusions on most outcomes
had a poor level of evidence. Equally, due to the lack of
adequate data, different tendinopathies were clustered
together in some comparisons (surgery vs sham surgery;
surgery vs ESWT; surgery vs physiotherapy) to increase
the strength of evidence. Although we acknowledge this
as a potential drawback of our study, we expect specific
treatments may potentially yield to similar (if not identical) effects on tendinopathies at different sites as they
share the same pathophysiology. However, we did not
generalise conclusions on comparisons of modalities to
include types of tendinopathy that did not contribute
any results for that specific comparison. Additionally,
the wide range of outcome measures used by authors
resulted in lack of homogeneity which made the conduction of a meta-analysis impossible. The different regimes
and intensities of physiotherapy and postoperative
14
rehabilitation used in studies might have affected the
results and, in patients treated surgically, the possibility
of improvement due to the postoperative rehabilitation/
physiotherapy cannot be overlooked. Due to the small
patient numbers in many of the studies, our inability to
calculate a minimal clinically important difference may
mask the fact that statistically significant differences
differ from ultimate meaningful benefit to these patients
with tendinopathy. Finally, as the duration of symptoms
of tendinopathy in some studies27 29 36 was only 3 months,
natural progression of the disease may have improved
patient outcomes.
ConClusIon
In this systematic review of 12 eligible RCTs in patients with
various tendinopathies, surgery was not superior to sham
surgery in patients with tendinopathy in the midterm and
long term. Further well-designed randomised studies with
large populations comparing surgery with both tendon
loading regimes and sham surgery are warranted. In the
meantime, we advocate that healthcare professionals who
treat patients with tendinopathies should reserve surgery
for selected cases and only after a sufficiently long course
(12 months) of evidence-based loading exercise has
failed.
Contributors NLM and DC conceived and designed the study. DC, CC and PK
performed analysis. All authors analysed the data. DC and NLM wrote the paper.
Funding This work was funded by grants from the Medical Research Council UK
(MR/R020515/1) and Versus Arthritis (21346).
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
data sharing statement DC and NLM has access to all the data and data are
available upon request.
open access This is an open access article distributed in accordance with the
Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
and indication of whether changes were made. See: https://creativecommons.org/
licenses/by/4.0/.
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