Overview

This trial is active, not recruiting.

Condition rotator cuff tear
Sponsor Vanderbilt University
Collaborator University of Colorado, Denver
Start date January 2006
End date January 2020
Trial size 380 participants
Trial identifier NCT00762580, 060109

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with full thickness rotator cuff tears being treated with physical therapy

Primary Outcomes

Measure
Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.
time frame: One year

Secondary Outcomes

Measure
Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)
time frame: One Year

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Principal investigator John E. Kuhn, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.