Nonoperative and Operative Treatments for Rotator Cuff Tears

Review
Annals of Internal Medicine
Systematic Review: Nonoperative and Operative Treatments for
Rotator Cuff Tears
Jennifer C. Seida, MPH; Claire LeBlanc, MD; Janine R. Schouten, BSc; Shima S. Mousavi, MD; Lisa Hartling, PhD; Ben Vandermeer, MSc;
Lisa Tjosvold, MLIS; and David M. Sheps, MD, MSc
Background: Many approaches exist for managing rotator cuff
tears.
Purpose: To compare the benefits and harms of nonoperative and
operative interventions on clinically important outcomes in adults
with rotator cuff tears.
Data Sources: 12 electronic databases (1990 to September 2009),
gray literature, trial registries, and reference lists were searched.
ate quality. Reported functional outcomes did not differ between
open versus mini-open repair, mini-open versus arthroscopic repair,
arthroscopic repair with versus without acromioplasty, or
single-row versus double-row fixation. Earlier return to work
was reported for mini-open repair versus open repair and for
continuous passive motion with physical therapy versus physical therapy alone. Open repairs showed greater improvement
in function than did arthroscopic debridement. Complication
rates were low across all interventions.
Study Selection: Controlled and uncontrolled studies that assessed
nonoperative or operative treatments or postoperative rehabilitation
for adults with confirmed rotator cuff tears were included. Operative studies in English-language publications and nonoperative and
postoperative rehabilitation studies in English, French, or German
were considered. Studies were assessed in duplicate.
Limitations: Limited evidence, which was often of low quality,
precluded conclusions for most comparisons. Language restrictions
may have excluded some relevant studies, and selective outcome
reporting may have introduced bias.
Data Extraction: 2 reviewers assessed risk for bias by using the
Cochrane Risk of Bias tool and the Newcastle–Ottawa Scale. One
reviewer rated the evidence by using a modified GRADE (Grading
of Recommendations Assessment, Development, and Evaluation)
approach. Data were extracted by one reviewer and verified by
another.
Primary Funding Source: Agency for Healthcare Research and
Quality.
Data Synthesis: 137 studies met eligibility criteria. All trials had
high risk for bias. Cohort and uncontrolled studies were of moder-
T
he rotator cuff comprises 4 muscle tendon units that
stabilize the humeral head within the shoulder joint
and aid in moving the upper extremity (1). “Rotator cuff
tear” refers to partial or full discontinuation of 1 or more
of these units due to traumatic injury or degeneration.
Incidence increases with age. Approximately 54% of adults
older than 60 years have a partial or complete rotator cuff
tear, compared with only 4% of those aged 40 to 60 years
(2). Symptoms include pain, weakness, and limitation of
motion (1).
Both nonoperative and operative treatments are used
to relieve pain and restore movement and function of the
shoulder (3). Most patients initially undergo 6 weeks to 3
months of nonoperative treatment, which may consist of
Conclusion: Evidence on the comparative effectiveness and harms
of various operative and nonoperative treatments for rotator cuff
tears is limited and inconclusive.
Ann Intern Med. 2010;153:246-255.
For author affiliations, see end of text.
This article was published at www.annals.org on 6 July 2010.
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combinations of oral medications and injections; rest from
activity; passive and active exercise; and such therapies as
heat, cold, or ultrasonography. Failing nonoperative treatment, the cuff may be surgically repaired by using an open,
mini-open, or arthroscopic approach. Various postoperative rehabilitation programs can help restore range of motion, strength, and function.
Earlier operative repair may result in better patient
outcomes, earlier return to work, and decreased costs (4,
5). Patients and clinicians struggle with when to abort nonoperative treatment in favor of surgery. The relative effectiveness of the various nonoperative and operative treatment options for patients with rotator cuff tears remains
uncertain. Our comparative effectiveness review examines
the relative effectiveness and safety of all nonoperative and
operative treatments for rotator cuff tears in adults.
See also:
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Editors’ Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
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246 © 2010 American College of Physicians
METHODS
We prospectively developed and followed a research protocol. An external panel of content experts provided input in
formulating the key questions and identifying interventions
and outcomes of interest. The full evidence report, including
search strategies and evidence tables, is available at www
.effectivehealthcare.ahrq.gov/reports/final.cfm.
Nonoperative and Operative Treatments for Rotator Cuff Tears
We investigated early versus late surgical repair, operative interventions, nonoperative interventions, postoperative rehabilitation, and operative versus nonoperative treatments. We also examined complications and prognostic
factors in all included studies.
Data Sources and Searches
We systematically searched MEDLINE, EMBASE,
Evidence-Based Medicine Reviews, the Cochrane Library,
AMED, CINAHL, SPORTDiscus with Full Text, Academic Search Elite, Health Source, Science Citation Index
Expanded (via Web of Science), Scopus, BIOSIS Previews,
CRISP, Current Controlled Trials, ClinicalTrials.gov, and
the Nederlands Trial Register from January 1990 to September 2009. Appendix Table 1, available at www.annals
.org, lists our MEDLINE search strategy. We also handsearched abstracts from recent scientific meetings and
reference lists of relevant reviews to identify additional
studies. No language restrictions were applied.
Study Selection
Trials, cohort studies, and prospective uncontrolled
studies that evaluated any nonoperative or operative treatment or postoperative rehabilitation for adults with confirmed rotator cuff tears were eligible for inclusion. We
defined uncontrolled studies as single-group studies that
reported baseline and follow-up data. For the purposes of
this review, we also considered cohort studies that compared the effectiveness of only 1 intervention across 2 patient populations (such as open repair in older versus
younger patients) to be uncontrolled studies. Confirmed
tears were defined as partial- or full-thickness lesions diagnosed by imaging or intraoperative findings. Studies were
required to enroll a minimum of 11 participants and report
at least 1 of the following outcomes: quality of life, function, time to return to work or activity, pain, range of motion, or strength. Operative studies were required to follow participants for at least 12 months; no follow-up
criteria were set for nonoperative or postoperative rehabilitation studies. We included operative studies published in English only because of a lack of translation
resources. We considered English-, German-, and
French-language publications for studies that examined
nonoperative treatments and postoperative rehabilitation, because the literature on these interventions was
sparse. One reviewer screened titles, keywords, and abstracts for broad relevance. Two independent reviewers
assessed the full publication of potentially relevant studies, and discrepancies were resolved by consensus.
Data Extraction and Quality Assessment
One reviewer extracted data by using a standardized
form, and a second reviewer verified the data for accuracy
and completeness. Reviewers resolved discrepancies by
consensus or through a third party.
Two reviewers independently assessed the methodological quality of included studies. We evaluated trials by
using the Cochrane Risk of Bias tool (6) and observational
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Context
Multiple therapies are available to treat rotator cuff tears.
Contribution
This systematic review of 137 studies found evidence that
patients with rotator cuff tears experienced improvements
in function after undergoing any of several operative procedures or nonoperative therapy. Few complications were
seen with the surgical procedures. Sparse comparative
data precluded recommendations for a superior treatment
approach.
Caution
The amount and strength of available evidence was low
for many therapies.
Implication
Several therapies might benefit patients with rotator cuff
tears and are associated with a reasonably low risk for
harm, but we do not yet know the most beneficial
therapy.
—The Editors
analytic studies by using a modified Newcastle–Ottawa
Scale (7). Uncontrolled studies were assessed for consecutive enrollment, complete outcome data, and standardized
or independent approach to outcome assessment. The
funding sources were recorded for all studies.
One reviewer (Dr. Hartling) graded the strength of
evidence according to published guidelines (8, 9) for the 4
key outcomes of quality of life, functional outcomes, time
to return to work, and cuff integrity. Four domains were
assessed: risk for bias (low, medium, or high), consistency
(no inconsistency, inconsistency present, unknown, or not
applicable), directness (direct or indirect), and precision
(precise or imprecise).
Data Synthesis and Analysis
We summarized the included studies qualitatively.
Controlled studies were combined by using meta-analysis
if the study design, study population, interventions being
compared, and outcomes were sufficiently similar. For continuous outcomes measured on different scales across studies, we calculated a standardized mean difference for the
pooled estimate. Results were combined by using randomeffects models, and statistical heterogeneity was quantified
by using the I2 statistic (10, 11).
Role of the Funding Source
The Agency for Healthcare Research and Quality
funded this review and provided feedback on the question
formulation and decision to submit for publication but was
not involved in the searches, selection, data extraction, data
analysis, or interpretation of the findings.
17 August 2010 Annals of Internal Medicine Volume 153 • Number 4 247
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Nonoperative and Operative Treatments for Rotator Cuff Tears
RESULTS
We identified 5677 citations and included 137 studies
in our review (Figure). Appendix Table 2, available at
www.annals.org, lists included and excluded studies, along
with the reasons for exclusion.
Table 1 summarizes general study characteristics.
Number of study participants ranged from 12 to 224 (median, 55; interquartile range [IQR], 33 to 93). Mean age
ranged from 41.2 to 80 years. Appendix Table 3, available
at www.annals.org, provides further study characteristics.
Methodological Quality
All randomized, controlled trials (RCTs) and controlled clinical trials had a high risk for bias. The most
common sources of potential bias were inadequate blinding, inadequate allocation concealment, and incomplete
outcome data. The methodological quality of the cohort
studies was moderate, with a median score of 5 out of 8
stars (IQR, 4 to 6 stars). Limitations in study design included lack of independent, blinded outcome assessment
Figure. Literature search and selection.
Citations retrieved from electronic
literature searches (n = 5677)
References selected for further examination
of titles and abstracts (n = 1008)
Potentially relevant
references identified
by hand searches (n = 2)
Not retrieved (n = 29)
Articles retrieved and evaluated in
full for inclusion (n = 981)
Excluded (n = 844)
Ineligible study design: 182
Not primary research: 153
Not confirmed rotator cuff tear: 107
No baseline data: 89
Non–English-language study: 79
Primary intention not treatment of
rotator cuff tear: 59
Not intervention of interest: 47
No numeric outcome of interest: 39
Enrolled ≤10 participants: 34
Follow-up <12 mo: 23
Not population of interest: 15
Multiple publication: 13
Published before 1990: 4
Included (n = 137)
248 17 August 2010 Annals of Internal Medicine Volume 153 • Number 4
and failure to adequately control for potential confounders.
Uncontrolled studies generally had moderate quality, with
consecutive enrollment, adequate follow-up, and standardized
outcome assessment reported in 63%, 77%, and 44% of studies, respectively. Funding sources were reported for only 49
studies (36%). Appendix Table 4, available at www.annals
.org, details the methodological quality of each study.
Early Versus Late Surgical Repair
One RCT (12), which compared early versus late surgical repair after failed nonoperative treatment, found superior
mean functional outcome scores with early repair but did not
report the statistical significance of this difference. The groups
did not significantly differ in cuff integrity. Overall, the evidence was too limited to make a conclusion. Table 2 summarizes the strength of the evidence for all comparisons.
Operative and Postoperative Rehabilitation Interventions
One hundred thirteen studies examined operative interventions, and 11 examined postoperative rehabilitation.
Studies that assessed surgery were categorized as comparing
an operative approach (such as open, mini-open, or arthroscopic), a technique (such as suture, anchor type, or configuration), or augmentation. Table 2 summarizes the
strength of the evidence for these comparisons.
Operative Approaches
Operative approaches were evaluated in 32 controlled
and 58 uncontrolled studies. The evidence on the specific
comparisons from the trials and cohort studies is examined
here. The uncontrolled studies consistently reported functional improvement from preoperative to postoperative
scores, regardless of the approach (open, mini-open, or arthroscopic), sample size, or outcome measure.
Open Versus Mini-open Repair. One RCT (13) and 2
retrospective cohort studies (14, 15) compared open with
mini-open repair. Quality of life (13), function (13–15),
cuff integrity (14, 15), and range of motion (13, 14) did
not significantly differ between the groups. The cohort
studies demonstrated statistically significant benefit from
mini-open repairs, with patients returning to work or activity approximately 1 month earlier (mean difference,
1.08 months [95% CI, 0.63 to 1.52 months]) and having
greater abduction strength (14).
Mini-open Versus Arthroscopic Repair. Ten studies (1
controlled clinical trial [16], 2 prospective cohort studies
[17, 18], and 7 retrospective cohort studies [19 –25]) compared mini-open with arthroscopic repair. Function did
not significantly differ, either for the controlled clinical
trial or the pooled estimate of 9 cohort studies (standardized mean difference, ⫺0.11 [CI, ⫺0.28 to 0.06]). Cuff
integrity (20, 23), pain (16, 18, 23, 24), range of motion
(16, 18, 20, 23, 24), and strength (16, 24) also did not
differ.
Open Versus Arthroscopic Repair. One prospective cohort study (26) and 2 retrospective cohort studies (27,
28) compared open versus arthroscopic rotator cuff repair.
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Nonoperative and Operative Treatments for Rotator Cuff Tears
A pooled estimate showed no differences in function (standardized mean difference, ⫺0.49 [CI, ⫺1.12 to 0.13]);
however, we found significant statistical heterogeneity
among the 3 studies (I2 ⫽ 83%). Patient age, type of tear,
and tear size did not seem to differ among the studies; the
heterogeneity may be due to differences in the study design
(prospective vs. retrospective) or length of follow-up. One
study (28) found no difference in pain or cuff integrity but
statistically significant differences in favor of arthroscopic
repair for external rotation range of motion and strength
and supraspinatus strength.
Two prospective cohort studies that compared open or
mini-open repair with arthroscopic repair found no difference in function (29, 30) or cuff integrity (29). Arthroscopic repair was favored for pain relief in one study (30),
whereas open or mini-open repair was favored for external
rotation in the other (29).
Open Repair Versus Debridement. Two controlled clinical trials (31, 32) and 2 retrospective cohort studies (33,
34) compared open repair with debridement. Improvement in function was statistically significant for the repair
groups (standardized mean difference for trials, 0.59 [CI,
0.15 to 1.03]; for cohort studies, 1.00 [CI, 0.11 to 1.90]);
however, we found substantial heterogeneity among the
cohort studies (I2 ⫽ 79%). The statistical heterogeneity
among studies may be explained by the different study
designs (prospective vs. retrospective) or tear sizes (small or
medium tears vs. massive tears). The magnitude of the
difference varied across studies from an absolute difference
of 2.2 on a 35-point scale (32) to 11.5 on an 83-point scale
(33). One cohort study (33) showed a statistically significant shorter time to maximum range of motion with arthroscopic debridement (3.2 vs. 6.8 months).
Arthroscopic Repair Versus Acromioplasty. Two RCTs
(35, 36) compared arthroscopic rotator cuff repair with
acromioplasty versus repair without acromioplasty. One
prospective cohort study (37) compared arthroscopic repair
with acromioplasty alone. Function did not differ between
the groups.
Other Approaches. Seven studies compared different
operative approaches: biceps tenotomy versus tenodesis
(38), rotator cuff repair versus palliative treatment (39),
arthroscopic rotator cuff repair plus superior labral
anterior-to-posterior lesion repair versus arthroscopic rotator cuff repair plus biceps tenotomy (40), arthroscopic rotator cuff repair plus tenodesis with versus without proximal biceps detachment (41), arthroscopic debridement
with versus without tenotomy (42), complete open repair
versus partial open repair versus debridement (43), and
open repair plus classic acromioplasty versus repair plus
modified acromioplasty (44). We found few clinically important differences between groups across all studies. No
differences in function were observed for 5 of the comparisons (38, 41– 44). One study (39) found a statistically
significant difference in function that favored rotator cuff
repair more than palliative treatment. Another (40) showed
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Table 1. Descriptive Characteristics of Included Studies
Characteristic
Study design
Controlled
Uncontrolled
Publication type
Peer-reviewed article
Abstract
Country of corresponding author
United States
Europe
Asia
Other
Language of publication
English
German
French
Studies, n
66 (21 RCTs; 6 CCTs; 13 PCs;
26 RCs)
71
133
4
49
56
18
14
130
4
3
Questions*
1. Early vs. late surgical repair
2. Operative interventions
3.
4.
5.
6.
1 RCT†
113 (12 RCTs; 5 CCTs;
11 PCs; 22 RCs‡;
63 uncontrolled)
Postoperative rehabilitation therapy
11 (6 RCTs; 1 CCT; 1 PC;
2 RCs; 1 uncontrolled)
Nonoperative interventions
10 (1 RCT; 2 RCs‡;
7 uncontrolled)
Nonoperative vs. operative interventions 5 (2 RCTs†; 1 PC; 2 RCs‡)
Complications
85
Prognostic factors
72
CCT ⫽ controlled clinical trial; PC ⫽ prospective cohort study; RC ⫽ retrospective cohort study; RCT ⫽ randomized, controlled trial.
* Questions were not mutually exclusive. All studies that examined complications
or prognostic factors also addressed an effectiveness question (questions 1 to 4).
† One study (12) addressed questions 1 and 4.
‡ One study (33) compared 4 treatment groups (2 operative and 2 nonoperative)
and is presented for questions 2, 3, and 4.
greater functional improvement with arthroscopic rotator
cuff repair with biceps tenotomy than with arthroscopic
rotator cuff repair plus superior labral anterior-to-posterior
lesion repair. However, the absolute difference of 4 points
on the 35-point scale is of questionable clinical importance. Range of motion (38, 41, 43) and strength (43) did
not significantly differ.
Operative Techniques
Fifteen controlled studies examined operative techniques. Six studies (4 RCTs [45– 48] and 2 cohort studies
[49, 50]) compared single-row suture anchor repairs with
double-row repairs. For function, the pooled estimate
showed statistically significant improvement that favored
double-row fixation (standardized mean difference for trials, 0.55 [CI, 0.02 to 1.07]; for cohort studies, 0.78 [CI,
0.46 to 1.11]). We found considerable heterogeneity
among the trials (P ⫽ 0.008; I2 ⫽ 75%) but not among
the cohort studies. The studies were similar in design, patient age, and tear type; the heterogeneity may be attributable to tear size, which ranged from small in one study (45)
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Nonoperative and Operative Treatments for Rotator Cuff Tears
Table 2. Summary of Strength of Evidence for Nonoperative and Operative Interventions
Comparison
Studies, n
Strength of
Evidence
Summary
Early vs. late repair
Operative approaches
Open RCR vs. mini-open RCR
1
32
3
Low
The evidence was too limited to make a conclusion.
Moderate
Moderate
Low
Moderate
Low
Moderate
Moderate
No difference for function. Some evidence for earlier return to work or
activity (by approximately 1 month) with mini-open repairs.
The evidence was too limited to make a conclusion for health-related
quality of life or cuff integrity.
No difference in function or cuff integrity.
The evidence was too limited to make a conclusion.
No difference in function.
The evidence was too limited to make a conclusion for cuff integrity.
Some evidence for greater improvement in function for open RCR.
No difference in function.
Low
Low
The evidence was too limited to make a conclusion.
The evidence was too limited to make a conclusion.
Moderate
No clinically important difference for function and no difference for
cuff integrity.
No difference in cuff integrity.
The evidence was too limited to make a conclusion for function.
The evidence was too limited to make a conclusion.
The evidence was too limited to make a conclusion.
Low
Mini-open RCR vs. arthroscopic RCR
Open RCR vs. arthroscopic RCR
Open or mini-open RCR vs. arthroscopic RCR
Open RCR vs. debridement
Arthroscopic RCR with acromioplasty vs.
without acromioplasty
Arthroscopic RCR vs. acromioplasty alone
Other approaches
Operative techniques
Single-row vs. double-row suture anchor
fixation
Mattress locking vs. simple stitch
Other techniques
Operative augmentation
Postoperative rehabilitation
Continuous passive motion with PT vs.
PT alone
Other postoperative rehabilitation
Nonoperative interventions
Nonoperative vs. operative treatment
10
3
2
4
2
1
7
15
6
2
7
3
10
3
7
3
5
Moderate
Low
Low
Low
Moderate
Low
Low
Low
No clinical or statistical difference in function. Some evidence for earlier
return to work with continuous passive motion.
The evidence was too limited to make a conclusion.
The evidence was too limited to make a conclusion.
The evidence was too limited to make a conclusion.
PT ⫽ physical therapy; RCR ⫽ rotator cuff repair.
to massive in another (47). Although the meta-analysis
showed statistical significance, the absolute differences in
the change scores were small (5 points on a 100-point
scale) (50) and therefore of questionable clinical relevance.
For cuff integrity, the pooled risk ratio from 3 trials (45–
47) showed no difference between groups (risk ratio, 1.20
[CI, 0.86 to 1.68]). However, 1 cohort study (50) found a
statistically significant difference that favored double-row
fixation. Measures of health-related quality of life (45), return to work (46), range of motion (47), and strength (45,
48, 49) did not differ across techniques.
Of the 2 studies that compared the effectiveness of
mattress stitch versus simple stitch, 1 controlled clinical
trial (51) favored mattress stitch for functional outcomes.
A prospective cohort study showed no difference between
groups (52). Cuff integrity (51, 52), pain (51, 52), and
range of motion (51) did not differ.
Each of the 7 remaining studies examined different
technique comparisons, including bioabsorbable tacks
versus suture tying (53), side-to-side versus tendon-tobone fixation (54), nonabsorbable versus absorbable suture (55), headed bioabsorbable corkscrew versus metal
suture anchor (56), mattress versus single transosseous
suture (57), ultrasonic suture welding versus hand-tied
knots (58), and staple fixation versus side-to-side suture
(59). The overall level of evidence was low for these
techniques. All studies assessed function; 3 found statis250 17 August 2010 Annals of Internal Medicine Volume 153 • Number 4
tically significant differences (12 to 15 points on a 100point scale) between the groups examined (53, 54, 56).
We noted a statistically significant difference in cuff
integrity in 1 study (55) but could not assess the difference in 2 others because of incomplete data reporting
(57, 59). Individual studies found statistically significant
differences for range of motion (56) and strength (57)
but not for pain (53, 55).
Operative Augmentation
Three small controlled and 5 uncontrolled studies
assessed surgical augmentation. One RCT (60) and 1
retrospective cohort study (61) compared porcine small intestine submucosa xenografts with no augmentation. Function (60) and cuff integrity (60, 61) did not significantly
differ. One study (61) found a slower rate of activityrelated pain resolution, an almost global loss of strength,
and less sport participation in the augmentation group.
One retrospective cohort study (62) compared patch graft
with no augmentation and found no statistically significant
difference in function. Range of motion for abduction was
significantly improved with patch augmentation (40° difference between groups). Five uncontrolled studies evaluated different types of augmentations, and all showed improvement in functional scores.
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Nonoperative and Operative Treatments for Rotator Cuff Tears
Postoperative Rehabilitation
Ten controlled studies and 1 uncontrolled study evaluated postoperative rehabilitation. Three RCTs (63– 65)
studied the addition of continuous passive motion to physical therapy. Overall, moderate evidence showed no difference in function or pain (pooled standardized mean differences, 0.08 [CI, ⫺0.37 to 0.52] and ⫺0.12 [CI, ⫺1.08 to
0.83], respectively). One study (63) found no statistically
significant difference between groups for range of motion
or strength. Another study (64) found that the time to
return to work favored continuous passive motion with
physical therapy over physical therapy alone (absolute difference of 12 and 21 days, respectively). Similarly, time to
90° abduction favored continuous passive motion. Continuous passive motion may improve recovery over the short
term.
Seven additional studies each reported on different
postoperative rehabilitation comparisons: a land-based program with or without aquatic therapy (66), inpatient versus
outpatient rehabilitation (67), individualized physical therapy plus home exercise versus home exercise alone (68),
rehabilitation with progressive loading versus traditional
loading (69), inpatient rehabilitation versus private outpatient rehabilitation with the Concept Global d’Epaule
method (70), standardized versus nonstandardized physical
therapy (71), and videotape-based versus therapist-based
home exercise instruction (72). One study (71) demonstrated that patients who received standardized physical
therapy showed statistically significant improvement in
function compared with those who received nonstandardized treatment. Progressive loading showed a statistically
significant reduction in pain versus traditional loading
(69). Outpatient therapy with the Concept Global
d’Epaule method reduced pain better than inpatient rehabilitation (70). Health-related quality of life (66), function
(68, 70, 72), pain (67, 71), range of motion (66 – 68), and
strength (68, 70) did not significantly differ across the remaining studies. We could not evaluate 1 study because
the investigators did not report levels of significance for
most outcomes (69). One uncontrolled study (73) demonstrated significant improvements in health-related quality
of life and function after rehabilitation.
Nonoperative Interventions
Three controlled and 7 uncontrolled studies examined
nonoperative interventions. One RCT (74) compared sodium hyaluronate with dexamethasone injections; however, no head-to-head comparison regarding the relative
efficacy of these interventions was reported. A retrospective
cohort study (75) compared rehabilitation that focused on
protecting the cuff through reliance on other muscles (deltoid, pectoralis major, and latissimus dorsi) with no rehabilitation. Differences in function that favored the rehabilitation group were statistically significant and clinically
important (absolute difference, 26.9 points on a 100-point
scale). A second retrospective cohort study (33) compared
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administration of steroid injection with no steroid injection among participants undergoing physical therapy
(treatment components not specified) and receiving oral
medications (not specified). Function (absolute difference,
11 on an 83-point scale) and time to maximum range of
motion (absolute difference, 4 months) significantly improved. For the uncontrolled studies, the degree of improvement in functional outcome scores varied considerably. The strength of evidence was too low to make
conclusions for any of the nonoperative interventions
(Table 2).
Operative Versus Nonoperative Interventions
Five studies compared nonoperative with operative
treatments. Four studies (12, 33, 76, 77) included either
physical therapy (treatment components not specified) or
stretching and strengthening exercises, with or without the
addition of steroid injections, oral medications, activity
modification, or manual therapy. One study (78) examined the use of shock-wave therapy. Nonoperative treatments were compared with either open or mini-open repair. One study included a third comparison group that
received arthroscopic debridement (33). All groups showed
statistically significant improvements regardless of the intervention. All but 1 study (76) showed statistically significant differences in function that favored operative repair.
One study (33) showed that patients who had arthroscopic
debridement had a statistically significant shorter time to
maximum range of motion (3.2 months) than did those in
the nonoperative and open repair groups (6.8 months
each). In general, the evidence was too limited to make
conclusions regarding comparative effectiveness (Table 2).
Complications
Sixty-four studies provided data on 34 different complications, and an additional 21 studies reported no complications during follow-up. Five complications were identified a priori to be most clinically relevant. Generally,
complications were uncommon (Appendix Table 5, available at www.annals.org). Recurrent tears occurred in a median of 3% of patients (IQR, 2% to 7%) in operative
studies and 4% (IQR, 0% to 5%) in postoperative rehabilitation studies. In most operative studies, no patients
had infections (IQR, 0% to 2%), whereas a median of
0.5% of patients (IQR, 1.3% to 6%) in postoperative rehabilitation studies reported infections. Stiffness occurred
in a median of 2% of patients (IQR, 0% to 3%) in operative studies, whereas 2 nonoperative studies reported
events in 4% and 7% of patients. Two percent of patients
(IQR, 1.8% to 4.5%) in operative studies developed reflex
sympathetic dystrophy, versus 0% and 7% in 2 postoperative rehabilitation studies. Neurologic injury was very rare
(median, 0% [IQR, 0% to 0.1%]). Because of the low
event rates, the benefit of receiving treatment for rotator
cuff tears seems to outweigh the risk for associated harms.
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Prognostic Factors
Seventy-two of the 137 studies assessed the effect of
known prognostic factors on patient outcomes. The number of prognostic factors examined across many different
outcome measures and the inconsistency among the investigators’ conclusions limited our ability to identify predictors of good outcome for nonoperative and operative treatments of rotator cuff tears. Overall, older age, increased
tear size, and greater preoperative symptoms were repeatedly found to be associated with recurrent tears. Sex, worker’s compensation board status, and duration of symptoms
were not found to be associated with poorer outcomes in
most studies that examined these variables.
DISCUSSION
Our comparative effectiveness review provides a current synthesis of the state of the evidence on nonoperative
and operative interventions for rotator cuff tears. Sparse
data are available for most comparisons, which precludes
firm conclusions for a single approach or the optimal overall management of this condition. Patients experienced
substantial improvements across all interventions. We
found few clinically important differences when comparisons between interventions were available. Complications
were rare, and we considered few to be clinically important. The benefit of receiving treatment for rotator cuff
tears seems to outweigh the risk for associated harms.
The strength of evidence was low for most interventions. This low grade was driven by the high risk for bias
within individual studies and the lack of consistency and
precision across studies. Many studies used weak study designs, failed to control for important sources of bias, and
lacked an independent comparison group. Trials had a
high risk for bias and frequently had inadequate blinding,
insufficient allocation concealment, and incomplete outcome data. Although blinding is not always feasible because of the nature of the intervention, adequate allocation
concealment is always possible in an RCT. Selective outcome reporting may also have introduced bias. The methodological quality was moderate for the cohort and uncontrolled studies. Many studies did not control for important
potential confounders in their design or analysis. We could
not assess the possibility of publication bias because of the
small number of studies for each comparison.
The lack of consistency and precision of results across
the studies was primarily due to varied comparisons made
across this body of literature; relatively few studies compared the same interventions. In addition, variation in the
pathologic presentation of rotator cuff disease contributed
to inconsistency among the studies. Although most patients had full-thickness tears, the size and configuration of
the tears, degree of fatty infiltration, and number and type
of comorbid conditions varied widely across the included
studies. Both outcome measures and timing of measurements varied considerably across studies, which made com252 17 August 2010 Annals of Internal Medicine Volume 153 • Number 4
parisons difficult. The most common outcome was function, but 21 different tools were used for this purpose, and
multiple tools were often used in the same study.
The quality of reporting was poor and inconsistent,
particularly in studies that evaluated nonoperative interventions. Physical therapy was often labeled as an intervention, with no description of treatment components or delivery. Studies rarely described the timing and frequency of
intervention components, the training and experience of
the staff who implemented the interventions, or any cointerventions, which leads to interpretive challenges.
Our review differs from previously published reviews
because it assesses the full range of nonoperative and operative treatment options, includes a broad range of study
designs, and considers only studies that confirmed the presence of rotator cuff tears. One previous review (79), published in 2004, similarly examined all treatment methods
in controlled and uncontrolled studies, but we have included the considerable literature published since then.
One limitation of our review is the language restriction,
which we applied because of a lack of translation resources.
In addition, we could not retrieve 29 potentially relevant
references. It is unlikely that these would have affected our
results, because we identified many of these citations
through searches of gray literature.
Priorities for future research include studies that compare the effectiveness of early versus delayed surgery. Patients generally have surgery after several months of failed
conservative treatment. Evidence is needed to determine
whether surgery should be delayed and, if so, for how long
and for whom. Evidence that compared the relative effectiveness of operative versus nonoperative treatments or
compared the various nonoperative treatment options was
sparse. Although most of the studies we reviewed focused
on the comparative effectiveness of operative treatments,
evidence for most individual treatment comparisons was
sparse, which leaves many unanswered questions. For future research, investigators should use a streamlined approach when evaluating operative treatments that begins
with assessing broad treatment questions before focusing
on detailed procedures. They should use a comparative
design and ensure that the diagnosis of rotator cuff tears is
confirmed appropriately. Consensus on clinically important and patient-important outcomes, as well as choice of
measurement tools, is needed to ensure consistency and
comparability across studies. Detailed reporting of study
methods and interventions is needed to allow appropriate
interpretation of results and replication of treatments. The
CONSORT (Consolidated Standards of Reporting Trials)
(80) and STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) (81) statements provide guidance for minimizing the risk for bias when designing RCTs and cohort studies, respectively.
We found moderate evidence for some interventions,
but the data were too limited to make definite conclusions
for most interventions examined. Few differences of cliniwww.annals.org
Nonoperative and Operative Treatments for Rotator Cuff Tears
cal importance were evident when we compared the relative effectiveness of the various treatments. Future studies,
of high methodological quality, are needed to explore the
relative effectiveness of early versus delayed surgery and of
nonoperative versus operative treatment, as well as among
the various nonoperative and operative interventions.
From the University of Alberta, Edmonton, Alberta, Canada.
Disclaimer: The authors of this report are responsible for its content.
Statements in the report should not be construed as endorsement by the
Agency for Healthcare Research and Quality or the U.S. Department of
Health and Human Services.
Grant Support: By the Agency for Healthcare Research and Quality,
U.S. Department of Health and Human Services (contract 290-020023).
Potential Conflicts of Interest: Ms. Seida, Dr. LeBlanc, Ms. Schouten,
Dr. Mousavi, Mr. Vandermeer, and Dr. Sheps: Grants received (money to
institution): Agency for Healthcare Research and Quality. Dr. LeBlanc:
Consultancy: University of Alberta. Dr. Hartling: Other (money to institution): Agency for Healthcare Research and Quality. Dr. Sheps: Consultancy: Agency for Healthcare Research and Quality. Disclosures can also
be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms
.do?msNum⫽M10-0825.
Corresponding Author: Jennifer C. Seida, MPH, Alberta Research Cen-
tre for Health Evidence, University of Alberta, 11402 University Avenue,
Edmonton, Alberta T6G 2J3, Canada; e-mail, [email protected].
Current author addresses and author contributions are available at
www.annals.org.
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MEDICINE JUNIOR INVESTIGATOR AWARDS
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17 August 2010 Annals of Internal Medicine Volume 153 • Number 4 255
Annals of Internal Medicine
Current Author Addresses: Ms. Seida, Ms. Schouten, Drs. Mousavi and
Hartling, and Mr. Vandermeer: Alberta Research Centre for Health Evidence, University of Alberta, Aberhart Center, 11402 University Avenue, Edmonton, Alberta T6G 2J3, Canada.
Dr. LeBlanc: University of Alberta, Aberhart Center, 11402 University
Avenue, Edmonton, Alberta T6G 2J3, Canada.
Ms. Tjosvold: 2K3.28 Walter C. Mackenzie Health Sciences Center,
University of Alberta, Edmonton, Alberta T6G 2R7, Canada.
Dr. Sheps: 10839 124th Street, Edmonton, Alberta T5M 0H4, Canada.
Author Contributions: Conception and design: J.C. Seida, C. LeBlanc,
L. Hartling, D.M. Sheps.
Analysis and interpretation of the data: J.C. Seida, C. LeBlanc, J.R.
Schouten, L. Hartling, B. Vandermeer, D.M. Sheps.
Drafting of the article: J.C. Seida, J.R. Schouten, S.S. Mousavi, L. Hartling, B. Vandermeer, L. Tjosvold, D.M. Sheps.
Critical revision of the article for important intellectual content: J.C.
Seida, C. LeBlanc, S.S. Mousavi, L. Hartling, B. Vandermeer.
Final approval of the article: J.C. Seida, C. LeBlanc, L. Hartling, L.
Tjosvold.
Statistical expertise: B. Vandermeer.
Obtaining of funding: L. Hartling.
Administrative, technical, or logistic support: J.C. Seida, L. Tjosvold.
Collection and assembly of data: J.C. Seida, J.R. Schouten, S.S. Mousavi,
L. Hartling, L. Tjosvold.
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