Skip to main content
Eligibility
for people ages 18 years to 100 years
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Details

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.

Keywords

Rotator Cuff Tear rotator cuff rehabilitation

Eligibility

You can join if…

Open to people ages 18 years to 100 years

• 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.

You CAN'T join if...

  • 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

Locations

  • Colorado University Sports Medicine
    Boulder, Colorado, 80304, USA
  • Universtiy Of Iowa
    Iowa City, Iowa, 52242, USA
  • Department of Orthopaedic Surgery, Washington Universtiy School of Medicine
    St. Louis, Missouri, 63110, USA
  • Hospital for Special Surgery
    New York, New York, 10021, USA
  • Ohio State
    Columbus, Ohio, 43221, USA
  • Sports Medicine & Shoulder Surgery, Orthopedic Institute
    Sioux Falls, South Dakota, 57117, USA
  • Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic
    Knoxville, Tennessee, 37922, USA
  • Vanderbilt Universtiy Medical Center
    Nashville, Tennessee, 37232, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt University
ID
NCT00762580
Study Type
Observational
Last Updated
November 2016