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

January 11, 2024 updated by: Rosemary A. Sanders, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

452

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Colorado University Sports Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242-1088
        • Universtiy Of Iowa
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Department of Orthopaedic Surgery, Washington Universtiy School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
    • Ohio
      • Columbus, Ohio, United States, 43221-3502
        • Ohio State
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sports Medicine & Shoulder Surgery, Orthopedic Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Universtiy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults between the ages of 18-100 with full thickness rotator cuff tears.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prospective
Patients with full thickness rotator cuff tears being treated with physical therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

University of Colorado, Denver
Washington University School of Medicine
University of Iowa
University of California, San Francisco
Ohio State University
Hospital for Special Surgery, New York
Arthrex, Inc.
Knoxville Orthopedic Clinic
Sports Medicine and Shoulder Surgery Orthopedic Institute

Investigators

  • Principal Investigator: John E. Kuhn, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimated)

September 30, 2008

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De Identified data from this cohort is only available to members of the MOON Shoulder Consortium. The member must provide a description of the use of the data to the research coordinator. The data request is then presented to the MOON consortium. A unanimous agreement of the plan by the consortium must be received prior to receiving the data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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