- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261196
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Dept. Orthopaedics, SUNY@Stony Brook
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Collagenase
Collagenase Injection
|
Anterior shoulder capsule injection
Other Names:
|
Placebo Comparator: Placebo
Placebo Injection
|
Anterior shoulder capsule injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active elevation of the affected shoulder
Time Frame: 30 days
|
Active Elevation in degrees by goniometer measurement
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Time Frame: 30 days
|
Active and passive internal/external rotation in degrees by goniometer measure
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shoulder 202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Capsulitis
-
University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
-
Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
-
Taif UniversityRecruitingAdhesive Capsulitis of ShoulderSaudi Arabia
-
Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
-
Health Education Research Foundation (HERF)RecruitingAdhesive Capsulitis of ShoulderPakistan
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
-
Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
-
Cairo UniversityRecruitingAdhesive Capsulitis of ShoulderEgypt
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
Clinical Trials on Collagenase
-
Stony Brook UniversityCompletedAdhesion of Flexor Tendon of HandUnited States
-
Azidus BrasilSuspended
-
HealthpointCompleted
-
State University of New YorkCompletedDupuytren's Contracture
-
State University of New YorkCompletedDupuytren's ContractureUnited States
-
Sheba Medical CenterUnknown
-
Endo PharmaceuticalsCompletedEdematous SkinUnited States
-
Zachary GerutAdvance Biofactures CorporationCompleted
-
National Taiwan University HospitalUnknownAlkaline Chemical Burn Of Cornea And Conjunctival Sac | Acid Chemical Burn Of Cornea And Conjunctival Sac | Benign Mucous Membrane Pemphigoid With Ocular InvolvementTaiwan
-
University Hospital, GhentTerminatedEsophageal Stricture | Stricture | Anastomotic | CollagenosisBelgium