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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00762580
Acronym
MOON
Enrollment
452
Registered
2008-09-30
Start date
2006-01-31
Completion date
2024-01-11
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

rotator cuff, rehabilitation

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026