Clinical trial NCT00762580: Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Official title: Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: rotator cuff
rehabilitation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Ohio State University
name: University of Iowa
name: University of California, San Francisco
name: Arthrex, Inc.
name: Knoxville Orthopedic Clinic
name: Washington University School of Medicine
name: Sports Medicine and Shoulder Surgery Orthopedic Institute
name: Hospital for Special Surgery, New York
First posted: 2008-09-30
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults between the ages of 18-100 with full thickness rotator cuff tears.

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.

Eligibility 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

Primary outcomes:
measure: Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.
timeFrame: One year
Secondary outcomes:
measure: Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)
timeFrame: One Year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Boulder
country: United States
facility: Colorado University Sports Medicine
state: Colorado
city: Iowa City
country: United States
facility: Universtiy Of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Department of Orthopaedic Surgery, Washington Universtiy School of Medicine
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Columbus
country: United States
facility: Ohio State
state: Ohio
city: Sioux Falls
country: United States
facility: Sports Medicine & Shoulder Surgery, Orthopedic Institute
state: South Dakota
city: Knoxville
country: United States
facility: Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Universtiy Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: John E. Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
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