Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears (MOON)

Vanderbilt University

Status: Completed

Conditions: Rotator Cuff Tear

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00762580

060109

Details and patient eligibility

About

The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears.

Full description

Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence increasing with age. While most people remain asymptomatic, it is unknown why some develop symptoms. In symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of patients, yet the majority of patients have a significant reduction pain despite failure of the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet it is not known which patient-related features predict success with nonoperative treatment. The general aim of this research effort is to identify patient features (historical information, physical examination findings, and MRI-based pathology) that would predict success (defined by reduction in visual analog pain scale, and patient satisfaction) with the nonoperative treatment of rotator cuff tears. The proposed study design is a prospective cohort study of patients with rotator cuff tears who will follow a standard physical therapy program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level 2 studies.

Study the effect of historical information on predicting success (as determined by pain relief and patient satisfaction) of nonoperative treatment using the EBM based physical therapy program in treating patients with rotator cuff tears.

Study the effect of physical examination findings on predicting success of a nonoperative treatment using the EBM-based physical therapy program in treating patients with rotator cuff tears.

Study the effect of the severity of the rotator cuff pathology (using standardized magnetic resonance imaging protocols) on predicting success of nonoperative treatment for patients with rotator cuff tears using the EBM-based physical therapy program.

Enrollment: 452 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients (18-100 years of age) with MRI findings of a full-thickness rotator cuff tear

Note: Criteria to obtain a shoulder MRI to evaluate for rotator cuff tear [Appendix D]:

1. Significant weakness (≥ 2 points per guidelines above.)
2. ADL pain or night pain >/= 7 on VAS
3. Significant impingement (per guidelines above) + with significant symptoms for ≥ 3 months.

Exclusion criteria

• Acute rotator cuff tears (generally due to a high velocity injury and symptoms of less than one month)

• Associated dislocations

• Associated fractures

• Systemic Rheumatologic disease, i.e. Rheumatoid Arthritis and Systemic Lupus Erythematosis

• Patients being treated for bilateral rotator cuff tears simultaneously

• Patients unable to complete the forms

• Pain from neck or scapula

• Previous shoulder surgery

• Glenohumeral arthritis (meets ≥ 1 of below criteria)

  • osteophytes >2mm on humeral head or glenoid
  • Joint space narrowing with sclerosis or cyst formation seen on true AP or axillary radiographs;
  • humeral head contacting acromion

• Adhesive capsulitis

Trial design

452 participants in 1 patient group

Prospective

Description:

Patients with full thickness rotator cuff tears being treated with physical therapy