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

Completed

• Conditions: Rotator Cuff Tear

• Registration Number: NCT00762580
• Lead Sponsor: Vanderbilt University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Status Verified: 2024-01
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.	One year

Secondary Outcome Measures

Name	Time	Method
Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)	One Year

Trial Locations

Locations (9)

Universtiy Of Iowa; 🇺🇸 Iowa City, Iowa, United States

Vanderbilt Universtiy Medical Center; 🇺🇸 Nashville, Tennessee, United States

Colorado University Sports Medicine; 🇺🇸 Boulder, Colorado, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Department of Orthopaedic Surgery, Washington Universtiy School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Ohio State; 🇺🇸 Columbus, Ohio, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic; 🇺🇸 Knoxville, Tennessee, United States

Sports Medicine & Shoulder Surgery, Orthopedic Institute; 🇺🇸 Sioux Falls, South Dakota, United States