Question 1
Does early surgical repair compared to late surgical repair (i.e., non-operative intervention followed by surgery) lead to improved health-related quality of life, decreased disability, reduced time to return to work/activities, less shoulder pain, and increased range of motion and/or strength?

Question 2
What is the comparative effectiveness of operative approaches (e.g., open surgery, mini-open surgery, arthroscopy) on improved health-related quality of life, decreased disability, reduced time to return to work/activities, less shoulder pain, and increased range of motion and/or strength?

a. Which operative approach should be used for different types of injuries (e.g., partial-thickness, full-thickness, small, medium, large or massive size of tear, with or without fatty infiltration of muscle tissue)?

Question 3
What is the comparative effectiveness of non-operative interventions (e.g., physical therapy, exercise, cortisone injections, acupuncture) on improved health-related quality of life, decreased disability, reduced time to return to work/activities, less shoulder pain, and increased range of motion and/or strength?

Question 4
Does operative repair compared to non-operative treatment lead to improved health-related quality of life, decreased disability, reduced time to return to work/activities, less shoulder pain, and increased range of motion and/or strength?

Question 5
What are the associated risks, adverse effects, and potential harms of operative and non-operative therapies?

Question 6
Which demographic (e.g., age, gender, ethnicity, co-morbidities, workers’ compensation claims) and clinical (e.g., size / severity of tear, duration of injury, fatty infiltration of muscle) prognostic factors predict better outcomes following non-operative and operative treatment?

Background

Shoulder pain is the third most common complaint among patients seeking medical attention for musculoskeletal disorders, preceded only by back and neck pain.(1) Disorders of the rotator cuff represent the most common cause of shoulder pain and include a spectrum of pathologic conditions that include bursitis, tendonitis, tendinosis, partial and full-thickness tears.(2) Although not a life-threatening condition, rotator cuff disease may cause significant morbidity from pain, stiffness, and weakness. This morbidity, in turn, may lead to significant disability, including absenteeism from work and lost productivity. The impact of rotator cuff disease on lost productivity is reflected in the high costs associated with shoulder injuries in the workers’ compensation system, and has been found to be the second most common cause after back pain for time away from work in manual laborers.(3-5) In addition, the impact of rotator cuff disease on health related quality of life, as measured by the SF-36, is comparable to the effects of hypertension, myocardial infarction, congestive heart failure, diabetes mellitus, and clinical depression.(6)

Despite the significant morbidity and cost associated with rotator cuff disease, there remains much uncertainty regarding the best non-operative and operative treatment options for this spectrum of disorders. Since the recognition of rotator cuff disease, and specifically rotator cuff tears, as a cause of shoulder pain, there have been thousands of studies evaluating the many treatment options. Over the past ten years, there have also been an increasing number of meta-analyses and systematic reviews published in an attempt to evaluate the existing evidence. The bulk of these reviews have included level one and level two evidence studies only, primarily randomized controlled trials, yet this represents only a small fraction of the existing literature. Although level of evidence and study design are crucial factors in assessing the strength of the “cause and effect” relationship between treatment and outcome, the state of the science on the treatment of rotator cuff tears can only be seen as comprehensive if all aspects of the existing literature are examined.

There is need for a systematic review that examines non-operative and operative treatment options for partial-thickness, full-thickness, and massive rotator cuff tears across all levels of evidence. It is not anticipated that clean, concise answers to the question “what is the best treatment option” will be found. However, a review should help to determine to what extent the existing literature provides evidence to support the various treatment options. By providing a comprehensive evaluation of the literature, a systematic review should assist clinicians in choosing the “best” treatment for their patients and aid researchers in the development of hypotheses for future studies.

Population(s)

• Adult patients (> 18 years of age) who have been diagnosed with partial- or full-thickness (including massive) rotator cuff tears (RCT).

Excluded:

• Patients with impingement syndrome, precursor conditions to tears, rheumatic disorders or a medical predisposition to RCT will not be considered in the evidence report.
• Studies that specifically examine RCT in professional athletes will be excluded, as the intent of the review is to focus on the general population.

Interventions

Common non-operative therapies including:

• physical therapy
• home exercise
• cortisone injections
• acupuncture.

Operative approaches for rotator cuff tear repair, including:

• arthroscopy
• mini-open and open surgery for RCT repair
• Comparators will include any other operative (Key Question 2) or non-operative (Key Question 3) interventions used in the treatment of RCT.

Outcomes

Primary Outcomes

1. Health-related quality of life
2. Disability
3. Time to return to work / activities
4. Shoulder pain
5. Range of motion
6. Strength

Adverse events

Timing

• Both short-term and long-term durations of follow-up will be considered.

Setting

• Patients in all settings (primary, specialty, in-patient, allied health professional clinics) will be considered.

References

1. Gomoll AH, Katz JN, Warner JJP, Millett PJ. Rotator cuff disorders: recognition and management among patients with shoulder pain. Arthritis and Rheumatism 2004;50:3751–61.
2. Iannotti JP. Full-thickness rotator cuff tears: factors affecting surgical outcome. J Am Acad Orthop Surg 1994;2:87-95.
3. Zakaria D, Robertson J, MacDermid JC, Hartford K, Koval J. Estimating the population at risk for Ontario Workplace Safety and Insurance Board-covered injuries or diseases. Chronic Dis Can 2002;23:17–21.
4. Zakaria D. Rates of carpal tunnel syndrome, epicondylitis, and rotator cuff claims in Ontario workers during 1997. Chronic Dis Can 2004;25:32–39.
5. Herberts P, Kadefors R, Hogfors C, Sigholm G. Shoulder pain and heavy manual labor. Clin Orthop Relat Res 1984;166–178.
6. MacDermid JC, Raos J, Drosdowech D, Faber K, Patterson S. The impact of rotator cuff pathology on isometric and isokinetics strength, function, and quality of life. Journal of Shoulder and Elbow Surgery 2004;13:593–8.