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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762580
Recruitment Status : Active, not recruiting
First Posted : September 30, 2008
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Ohio State University
University of Iowa
University of California, San Francisco
Arthrex, Inc.
Knoxville Orthopedic Clinic
Washington University School of Medicine
Sports Medicine and Shoulder Surgery Orthopedic Institute
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Rosemary A. Sanders, 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.

Condition or disease
Rotator Cuff Tear

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.

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Study Type : Observational
Actual Enrollment : 452 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Study Start Date : January 2006
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults between the ages of 18-100 with full thickness rotator cuff tears.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762580


Locations
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United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Colorado University Sports Medicine
Boulder, Colorado, United States, 80304
United States, Iowa
Universtiy Of Iowa
Iowa City, Iowa, United States, 52242-1088
United States, Missouri
Department of Orthopaedic Surgery, Washington Universtiy School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Ohio State
Columbus, Ohio, United States, 43221-3502
United States, South Dakota
Sports Medicine & Shoulder Surgery, Orthopedic Institute
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic
Knoxville, Tennessee, United States, 37922
Vanderbilt Universtiy Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
University of Colorado, Denver
Ohio State University
University of Iowa
University of California, San Francisco
Arthrex, Inc.
Knoxville Orthopedic Clinic
Washington University School of Medicine
Sports Medicine and Shoulder Surgery Orthopedic Institute
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: John E. Kuhn, MD Vanderbilt University Medical Center
Publications:
Ciepiela MD, Burkhead WZ. Classification of Rotator Cuff Tears. In: Burkhead WZ, ed. Rotator Cuff Disorders.Lippincott Williams & Wilkins, 1996.
Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement 1960;20:37-46.

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Responsible Party: Rosemary A. Sanders, Research Coordinator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00762580    
Other Study ID Numbers: 060109
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Rosemary A. Sanders, Vanderbilt University:
rotator cuff
rehabilitation
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries