Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
- Registration Number
- NCT00261196
- Lead Sponsor
- Stony Brook University
- Brief Summary
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
- Detailed Description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).
Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- diagnosis of frozen shoulder of at least one month duration
Exclusion Criteria
- shoulder arthritis
- rotator cuff tears
- any chronic, serious, uncontrolled medical condition
- inability to conform to study visits (20-30 per year)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Collagenase Collagenase Collagenase Injection Placebo Collagenase Placebo Injection
- Primary Outcome Measures
Name Time Method Active elevation of the affected shoulder 30 days Active Elevation in degrees by goniometer measurement
- Secondary Outcome Measures
Name Time Method Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function. 30 days Active and passive internal/external rotation in degrees by goniometer measure
Trial Locations
- Locations (1)
Dept. Orthopaedics, SUNY@Stony Brook
🇺🇸Stony Brook, New York, United States