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

NCT ID: NCT00762580

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 452 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2024-01-11

Brief 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.

Detailed 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.

Conditions

Rotator Cuff Tear

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Knoxville Orthopedic Clinic

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Sports Medicine and Shoulder Surgery Orthopedic Institute

UNKNOWN

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Rosemary A. Sanders

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John E. Kuhn, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Colorado University Sports Medicine

Boulder, Colorado, United States

Universtiy Of Iowa

Iowa City, Iowa, United States

University of California at San Francisco

San Francisco, California, United States

Department of Orthopaedic Surgery, Washington Universtiy School of Medicine

St Louis, Missouri, United States

Hospital for Special Surgery

New York, New York, United States

Ohio State

Columbus, Ohio, United States

Sports Medicine & Shoulder Surgery, Orthopedic Institute

Sioux Falls, South Dakota, United States

Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic

Knoxville, Tennessee, United States

Vanderbilt Universtiy Medical Center

Nashville, Tennessee, United States

Countries

United States

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Other Identifiers

060109

Identifier Type: -

Identifier Source: org_study_id