Introduction

The rotator cuff (RC) is comprised of four

muscle-tendon units, which stabilize the

humeral head within the shoulder joint and

aid in powering the movement of the upper

extremity. RC tears refer to a partial or full

discontinuation of one or more of the

muscles or tendons and may occur as a

result of traumatic injury or degeneration

over a period of years. The incidence of RC

tears is related to increasing age; 54

percent of patients over the age of 60 years

have a partial or complete RC tear

compared with only 4 percent of adults

under 40 years of age. Although not a lifethreatening condition, RC tears may cause

significant pain, weakness, and limitation

of motion.

Both nonoperative and operative treatments

are used in an attempt to relieve pain and

restore movement and function of the

shoulder. The majority of patients first

undergo 6 weeks to 3 months of

nonoperative treatment, which may consist

of any combination of pain management

(medications and injections), rest from

activity, passive and active exercise, and

treatments with heat, cold or ultrasound.

Failing nonoperative treatment, the cuff

may be surgically repaired using an open,

mini-open, or all-arthroscopic approach.

A variety of postoperative rehabilitation

programs are used to restore range of

motion, muscle strength, and function

following operative treatment.

Comparative Effectiveness of Nonoperative and

Operative Treatments for Rotator Cuff Tears

Executive Summary

Effective Health Care Program

Effective Health Care Program

The Effective Health Care Program

was initiated in 2005 to provide valid

evidence about the comparative

effectiveness of different medical

interventions. The object is to help

consumers, health care providers, and

others in making informed choices

among treatment alternatives. Through

its Comparative Effectiveness Reviews,

the program supports systematic

appraisals of existing scientific

evidence regarding treatments for

high-priority health conditions. It also

promotes and generates new scientific

evidence by identifying gaps in

existing scientific evidence and

supporting new research. The program

puts special emphasis on translating

findings into a variety of useful

formats for different stakeholders,

including consumers.

The full report and this summary are

available at www.effectivehealthcare.

ahrq.gov/reports/final.cfm.

Comparative Effectiveness Review

Number 22

Effective

Health Care
2

Earlier operative treatment has been proposed to

improve patient outcomes, and result in an earlier return

to work, and decreased costs; therefore, patients and

clinicians face the difficult decision of when to forgo

attempts at nonoperative treatment in favor of operative

treatment. Moreover, the comparative effectiveness of

the various nonoperative and operative treatment

options for patients with RC tears remains uncertain.

Key Questions

The following key questions (KQ) were investigated for

a population of adult patients with partial- and fullthickness RC tears:

1. Does early surgical repair compared to late

surgical repair (i.e., nonoperative intervention

followed by surgery) lead to improved healthrelated quality of life, decreased disability, reduced

time to return to work/activities, higher rate of cuff

integrity, less shoulder pain, and increased range

of motion and/or strength?

2. What is the comparative effectiveness of operative

approaches (e.g., open surgery, mini-open surgery,

and arthroscopy) and postoperative rehabilitation

on improved health-related quality of life,

decreased disability, reduced time to return to

work/activities, higher rate of cuff integrity, less

shoulder pain, and increased range of motion

and/or strength?

i. Which operative approach should be used for

different types of tears (e.g., partial-thickness

or full-thickness; small, medium, large, or

massive; with or without fatty infiltration of

muscle tissue)?

3. What is the comparative effectiveness of

nonoperative interventions on improved healthrelated quality of life, decreased disability, reduced

time to return to work/activities, higher rate of cuff

integrity, less shoulder pain, and increased range

of motion and/or strength? Nonoperative

interventions include, but are not limited to,

exercise, manual therapy, cortisone injections,

acupuncture, and treatments and modalities

typically delivered by physical therapists,

osteopaths, and chiropractors.

i. Which nonoperative treatment approach

should be used for different types of tears

(e.g., partial-thickness, full-thickness; small,

medium, large, or massive; with or without

fatty infiltration of muscle tissue)?

4. Does operative repair compared with nonoperative

treatment lead to improved health-related quality

of life, decreased disability, reduced time to return

to work/activities, higher rate of cuff integrity, less

shoulder pain, and increased range of motion

and/or strength?

5. What are the associated risks, adverse effects, and

potential harms of nonoperative and operative

therapies?

6. Which demographic (e.g., age, gender, ethnicity,

comorbidities, workers’ compensation claims) and

clinical (e.g., size/severity of tear, duration of

injury, fatty infiltration of muscle) prognostic

factors predict better outcomes following

nonoperative and operative treatment?

i. Which (if any) demographic and clinical

factors account for potential differences in

surgical outcomes between patients who

undergo early versus delayed surgical

treatment?

Methods

Literature Search

The following bibliographic databases were searched

systematically for studies published between 1990 and

2009: Medline®, Embase, Evidence-Based Medicine

Reviews – The Cochrane Library, AMED, Cumulative

Index to Nursing and Allied Health Literature

(CINAHL), SPORTDiscus with Full Text, Academic

Search Elite, Health Source, Science Citation Index

Expanded (via Web of Science®), Scopus®, BIOSIS

Previews®, and PubMed. Additional searches of the

Grey Literature were conducted in Conference Papers

Index, Computer Retrieval of Information on Scientific

Projects (CRISP), Scopus®, as well as government Web

sites by the U.S. Food and Drug Administration and

Health Canada. Databases that yielded included studies

(Medline®, Embase, Central, and CINAHL®) were

searched again in September 2009 to identify recently

published studies. Hand searches were conducted to
3

identify literature from symposia proceedings from the

following scientific meetings: Arthroscopy Association

of North America (2007-2009), American Academy of

Orthopaedic Surgeons (2007-2009), American Physical

Therapy Association (2006-2008), American Shoulder

and Elbow Surgeons (2005-2008), American Society of

Shoulder and Elbow Therapists (2004-2008), European

Congress of Physical and Rehabilitation Medicine

2008, Congress of the European Society for Surgery of

the Shoulder and the Elbow (2009), and the MidAmerica Orthopaedic Association (2006-2008).

Ongoing studies were identified by searching clinical

trials registers and by contacting experts in the field.

Reference lists of relevant reviews were searched to

identify additional studies. No language restrictions

were applied.

Study Selection

Two reviewers independently screened titles and

abstracts using general inclusion criteria. The full text

publication of all articles identified as “include” or

“unclear” were retrieved for formal review. Each fulltext article was assessed independently by two

reviewers using detailed a priori inclusion criteria and a

standardized form. Disagreements were resolved by

consensus or by third-party adjudication.

Controlled and prospective uncontrolled studies were

included in the review if they were published in 1990 or

later, included a minimum of 11 participants, focused

on adults with a partial or full-thickness tear that was

confirmed by imaging or intraoperative findings, and

examined any operative or nonoperative intervention or

postoperative rehabilitation. In addition, studies were

required to report on at least one outcome of interest

(quality of life, function, time to return to work, cuff

integrity, pain, range of motion, and/or strength) and

have a minimum followup duration of 12 months for

operative studies. For the review update, only controlled

studies were included.

Quality Assessment and Rating of the Body of

Evidence

Two reviewers independently assessed the

methodological quality of included studies. The

Cochrane Collaboration’s “risk of bias” tool was used to

assess randomized controlled trials and controlled

clinical trials. Observational analytic studies were

assessed using modified cohort and case-control

Newcastle-Ottawa Quality Assessment Scales. The

methodological quality of uncontrolled studies was

assessed using a quality checklist developed by the

University of Alberta Evidence-based Practice Center;

the checklist consisted of three items: consecutive

enrollment, incomplete outcome data, and

standardized/independent approach to outcome

assessment. In addition, the source of funding was

recorded for all studies.

The body of evidence was rated by one reviewer using

the EPC GRADE (Grading of Recommendations

Assessment, Development and Evaluation) approach.

The strength of evidence was assessed for four key

outcomes considered by the clinical investigators to be

most clinically relevant: health-related quality of life,

functional outcomes, time to return to work, and cuff

integrity. The following four major domains were

assessed: risk of bias (low, medium, high), consistency

(no inconsistency, inconsistency present, unknown, or

not applicable), directness (direct, indirect), and

precision (precise, imprecise).

Data Extraction

Data were extracted by one reviewer using a

standardized form and verified for accuracy and

completeness by a second reviewer. Extracted data

included study characteristics, inclusion/exclusion

criteria, participant characteristics, interventions, and

outcomes. Reviewers resolved discrepancies by

consensus or in consultation with a third party.

Data Analysis

Evidence tables and qualitative descriptions of results

were presented for all included studies. Comparative

studies were considered appropriate to combine in a

meta-analysis if the study design, study population,

interventions being compared, and outcomes were

deemed sufficiently similar. Results were combined

using random effects models. Statistical heterogeneity

was quantified using the I-squared (I

2

) statistic. Graphs

were created to display the preoperative and

postoperative scores of uncontrolled studies, cohort

studies, and trials over the duration of the study

followup period.
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Results

Description of Included Studies

The search strategy identified 5,677 citations; 137

unique studies met the eligibility criteria and were

included in the review. The studies included 27 trials,

39 cohort studies, and 71 uncontrolled studies. The

number of participants in the studies ranged from 12

to 224 (median=55 [IQR: 33 to 93]). The mean age of

study participants ranged from 41.2 to 80 years.

Methodological Quality of Included Studies

All the randomized controlled trials and controlled

clinical trials were considered to have a high risk of

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 stars on a possible

score of 8 stars (IQR: 4 to 6). Common weaknesses in

the design of the studies included lack of independent

blind outcome assessment and failure to control

adequately for potential confounding factors.

Uncontrolled studies generally had moderate quality,

with consecutive enrollment, adequate followup, and

standardized outcome assessment being reported in 63

percent, 77 percent, and 44 percent of studies,

respectively. Across all studies, a source of funding

was rarely reported (n=49, 36 percent).

Results of Included Studies

The results of the included studies are presented by the

key question(s) they address. A table with the

summary of findings for nonoperative and operative

interventions is presented below.

Key Question 1: Early versus late surgical repair.

One study compared early surgical repair versus late

surgical repair after failed nonoperative treatment.

Patients receiving early surgery had superior function

compared with the delayed surgical group; however,

the level of significance was not reported.

Key Question 2: Comparative effectiveness of

operative interventions and postoperative

rehabilitation. A total of 113 studies examined the

effectiveness of operative interventions, while 11

studies evaluated postoperative rehabilitation protocols

following surgery. A median of 55 patients (IQR: 34 to

95) with a median age of 58.6 years (IQR: 55.5 to

61.7) were included in the operative studies. Males

comprised an average of 64.6 percent of study

participants. For postoperative rehabilitation, studies

included a median of 61 participants (IQR: 36 to 79.5)

with a median age of 58.0 years (IQR: 56.3 to 60.8).

Males comprised an average of 58.9 percent of study

participants.

Studies assessing operative treatments were

categorized as focusing on an operative approach (e.g.,

open, mini-open, arthroscopic, and debridement),

technique (i.e., suture or anchor type or configuration)

or augmentation for RC repair. The majority of

surgical studies (32 comparative studies and 58

uncontrolled studies) evaluated operative approaches.

The comparative studies provided moderate evidence

indicating no statistical or clinically important

differences in function between open and mini-open

repairs; however, there was some evidence suggesting

an earlier return to work by approximately 1 month for

mini-open repairs. Similarly, there was moderate

evidence demonstrating no difference in function

between mini-open and arthroscopic repair and

arthroscopic repair with and without acromioplasty.

There was moderate evidence for greater improvement

in function for open repairs compared with

arthroscopic debridement. The strength of evidence

was low for the remaining comparisons and outcomes

examined in the studies, precluding any conclusions

regarding their comparative effectiveness. The

uncontrolled studies consistently reported functional

improvement from preoperative to postoperative

scores, regardless of the type of approach used (open,

mini-open, or arthroscopic), the study design, the

sample size of the study, or the type of outcome

measure used.

Operative techniques were examined in 15

comparative studies. Six studies compared single-row

versus double-row fixation of repairs, providing

moderate evidence of no clinically significant

difference in function and no difference in cuff

integrity. There was moderate evidence for no

difference in cuff integrity between mattress locking

and simple stitch. The evidence was too limited to

make conclusions about the other techniques.
5

Eight studies, including three comparative and five

uncontrolled studies, assessed augmentations for

operative repair. The three comparative studies were

relatively small and no overall conclusions were

possible. Although the five uncontrolled studies

evaluated different types of augmentation, they all

indicated improvement in functional score from

baseline to final followup.

Of the 11 postoperative rehabilitation studies (10

comparative, 1 uncontrolled), 3 compared continuous

passive motion with physical therapy versus physical

therapy alone. These three studies provided moderate

evidence of no clinically important or statistically

significant difference in function, but some evidence

for earlier return to work with continuous passive

motion. Each of the remaining studies examined

different rehabilitation protocols; therefore, the

evidence was too limited to make any conclusions

regarding their comparative effectiveness.

Key Question 3: Comparative effectiveness of

nonoperative interventions. Nonoperative

interventions were examined in three comparative and

seven uncontrolled studies. The studies included a

median of 42 patients (IQR: 25.3 to 73.3), with a

median age of 61 years (IQR: 60.4 to 61.5). Males

comprised an average of 50 percent of participants.

Each of the comparative studies assessed different

interventions, including: sodium hyaluraonate versus

dexamethasone; rehabilitation versus no rehabilitation

(not otherwise specified); and physical therapy, oral

medications, and steroid injection versus physical

therapy, oral medications, and no steroid injection. The

limited evidence precludes conclusions of comparative

effectiveness. The degree of improvement in functional

outcome scores varied considerably across the

uncontrolled studies.

Key Question 4: Comparative effectiveness of

nonoperative versus operative interventions. Five

studies compared nonoperative to operative treatments,

with a median sample size of 103 (IQR: 40 to 108). The

mean ages in the studies ranged from 46.8 to 64.8

years. Males represented 55 percent of study

participants. The interventions varied across studies, but

generally the nonoperative arms included components

such as steroid injection, stretching, and strengthening

and were compared with open repair or debridement.

The evidence was too limited to make conclusions

regarding the comparative effectiveness of the

interventions.

Key Question 5: Complications. A total of 85 studies

provided data on 34 different complications of

nonoperative, operative, and postoperative rehabilitation

interventions. Complications were poorly reported, with

studies providing limited information on how

complications were defined and assessed. In 21 studies,

it was reported that no complications occurred during

the course of the study. In general, the rates of

complication were low and the majority of

complications were not deemed to be clinically

important or were reported in few studies.

Key Question 6: Prognostic factors. Overall, 72 of the

137 studies examined the impact of prognostic factors

on patient outcomes. General conclusions are limited,

due to the varied methodologies across studies,

particularly the different outcomes for which prognostic

factors were evaluated. There is some evidence that tear

size, age, and extent of preoperative symptoms may

modify outcomes; while, workers’ compensation board

(WCB) status, sex, and duration of symptoms generally

showed no significant impact.
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The following table summarizes the findings of the studies and indicates the overall

strength of the evidence on each topic examined.

Summary of strength of evidence for nonoperative and operative interventions for RC tears

Strength

Comparison (number of studies) of evidence Summary

Early vs. late repair

Early RCR vs. late RCR (n=1) Low The evidence was too limited to make a conclusion.

Operative approaches

Open RCR vs. mini-open RCR (n=3) Moderate No statistically significant or clinically important

difference for function. Some evidence for earlier return

to work or sports (by approximately 1 month) with

mini-open repairs.

Low The evidence was too limited to make a conclusion for

health-related quality of life.

Mini-open RCR vs. arthroscopic RCR (n=10) Moderate No difference in function or cuff integrity.

Open RCR vs. arthroscopic RCR (n=3) Low The evidence was too limited to make a conclusion.

Open or mini-open RCR vs. arthroscopic Moderate No difference in function.

RCR (n=2) Low The evidence was too limited to make a conclusion for

cuff integrity.

Open RCR vs. open or arthroscopic Moderate Some evidence for greater improvement in function for

debridement (n=4) open RCR.

Arthroscopic RCR with acromioplasty vs. Moderate No difference in function.

without acromioplasty (n=3)

Arthroscopic RCR vs. acromioplasty alone Low The evidence was too limited to make a conclusion.

Biceps tenotomy vs. tenodesis (n=1) Low The evidence was too limited to make a conclusion.

RCR vs. palliative treatment (n=1) Low The evidence was too limited to make a conclusion.

Arthroscopic RCR with SLAP repair vs. Low The evidence was too limited to make a conclusion.

arthroscopic RCR with biceps tenotomy (n=1)

Mini-open RCR plus tenodesis with detachment Low The evidence was too limited to make a conclusion.

vs. without detachment (n=1)

Arthroscopic debridement with biceps tenotomy Low The evidence was too limited to make a conclusion.

vs. without tenotomy (n=1)

Complete open RCR vs. partial open RCR vs. Low The evidence was too limited to make a conclusion.

debridement (n=1)

Open RCR with classic open acromioplasty Low The evidence was too limited to make a

vs. open RCR with modified open conclusion.

acromioplasty (n=1)

Operative techniques

Single-row vs. double-row suture anchor Moderate No clinically important difference for function and

fixation (n=6) no difference for cuff integrity.

Bioabsorbable tacs vs. suture tying (n=1) Low The evidence was too limited to make a conclusion.

Side-to-side vs. tendon-to-bone fixation (n=1) Low The evidence was too limited to make a conclusion.

Nonabsorbable vs. absorbable sutures (n=1) Low The evidence was too limited to make a conclusion.

Bioabsorbable corkscrews vs. metal suture Low The evidence was too limited to make a conclusion.

anchor (n=1)
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The following table summarizes the findings of the studies and indicates the overall

strength of the evidence on each topic examined.

Summary of strength of evidence for nonoperative and operative interventions for RC tears

Strength

Comparison (number of studies) of evidence Summary

Operative techniques (continued)

Mattress locking vs. simple stitch (n=2) Moderate No difference in cuff integrity.

Low The evidence was too limited to make a conclusion for

function.

Mattress vs. transosseous suture (n=1) Low The evidence was too limited to make a conclusion.

Ultrasonic welding vs. hand-tied knots (n=1) Low The evidence was too limited to make a conclusion.

Staple fixation vs. side-to-side suture (n=1) Low The evidence was too limited to make a conclusion.

Operative augmentation

Porcine small intestine submucosa vs. no Low The evidence was too limited to make a conclusion.

augmentation (n=2)

Patch graft vs. no augmentation (n=1) Low The evidence was too limited to make a conclusion.

Postoperative rehabilitation

Continuous passive motion with PT treatment Moderate No clinical or statistical difference in function. Some

vs. PT treatment (n=3) evidence for earlier return to work with continuous

passive motion.

Aquatic therapy with land-based therapy vs. Low The evidence was too limited to make a conclusion.

land-based therapy (n=1)

Inpatient vs. day patient rehabilitation (n=1) Low The evidence was too limited to make a conclusion.

Individualized PT program with home exercise Low The evidence was too limited to make a conclusion.

vs. home exercise (n=1)

Progressive vs. traditional loading (n=1) Low The evidence was too limited to make a conclusion.

Inpatient rehabilitation vs. outpatient CGE (n=1) Low The evidence was too limited to make a conclusion.

Standardized vs. non-standardized PT program Low The evidence was too limited to make a conclusion.

(n=1)

Videotape vs. PT home exercise instruction Low The evidence was too limited to make a conclusion.

(n=1)

Nonoperative interventions

Sodium hyaluraonate vs. dexamethasone (n=1) Low The evidence was too limited to make a conclusion.

Rehabilitation vs. no rehabilitation (n=1) Low The evidence was too limited to make a conclusion.

Physical therapy, oral medications and steroid Low The evidence was too limited to make a conclusion.

injection vs. physical therapy, oral medications

and no steroid injection (n=1)

Nonoperative vs. operative treatment

Shock-wave therapy vs. mini-open RCR (n=1) Low The evidence was too limited to make a conclusion.

Steroid injection, physical therapy, and activity Low The evidence was too limited to make a conclusion.

modification vs. open repair (n=1)

Physical therapy vs. open or mini-open RCR Low The evidence was too limited to make a conclusion.

Physical therapy treatment, oral medication, Low The evidence was too limited to make a conclusion.

and steroid injection vs. arthroscopic

debridement vs. open repair (n=1)
The following table summarizes the findings of the studies and indicates the overall

strength of the evidence on each topic examined.

Summary of strength of evidence for nonoperative and operative interventions for RC tears

Strength

Comparison (number of studies) of evidence Summary

Nonoperative vs. operative treatment (continued)

Passive stretching, strengthening, and Low The evidence was too limited to make a conclusion.

corticosteroid injection vs. open repair with

acromioplasty (n=1)

CGE = Concept Global d’Epaule; RCR = rotator cuff repair; SLAP = superior labral from anterior to posterior

Future Research

Recommendations for further research:

• Primary evidence is needed, comparing the

effectiveness of early versus delayed surgery,

nonoperative versus operative interventions, and

among the nonoperative treatment options. Future

research examining the comparative effectiveness

of open, mini-open, or arthroscopic approaches is

also a priority, as arthroscopic procedures are more

costly and technically difficult.

• All future studies should employ a comparison or

control group and should ensure comparability of

treatment groups, optimally through the use of

randomization.

• Future research should seek to minimize bias by

blinding outcome assessors, using validated and

standardized outcome assessment instruments, and

ensuring adequate allocation concealment (where

applicable) and the appropriate handling and

reporting of missing data.

• Studies examining the long-term effectiveness of

treatments over the course of several years are

needed; at the very least, studies should follow

patients for a minimum of 12 months.

• To avoid numerous studies on disparate

interventions, the interventions and comparisons

chosen for study should be guided by consensus

regarding the most promising and/or controversial

interventions.

• To ensure consistency and comparability across

future studies, consensus is needed on outcomes

that are important to both clinicians and patients.

Moreover, consensus on minimal clinically

important differences is needed to guide study

design and interpretation of results.

• To permit the appropriate interpretation of results,

future research needs to be reported in a consistent

and comprehensive manner.

Conclusions

For the majority of interventions, only sparse data are

available, precluding firm conclusions for any single

approach or for the optimal overall management of this

condition. The paucity of evidence related to early

versus delayed surgery is of particular concern, as

patients and providers must decide whether to attempt

initial nonoperative management or proceed

immediately with surgical repair. The majority of the

data is derived from studies of low methodological

quality or from study designs associated with higher

risk of bias (e.g., observational and before-and-after

studies). Overall, the evidence shows that all

interventions result in substantial improvements;

however, few differences of clinical importance are

evident when comparisons between interventions are

available. Complication rates were generally low and

the majority of complications were not deemed to be

clinically important; therefore, the benefit of receiving

treatment for rotator cuff tears appears to outweigh the

risk of associated harms. Future research is needed to

determine the relative effectiveness of rotator cuff

treatment options.

AHRQ Pub. No. 10-EHC050-1

July 2010