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Completed

NCT Number: NCT00762580

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California at San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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]:

  • Significant weakness (≥ 2 points per guidelines above.)
  • ADL pain or night pain >/= 7 on VAS
  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Acronym: MOON

Important dates

Study start
2006
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2008
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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