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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00261196
Other study ID # Shoulder 202
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date January 2006
Est. completion date January 2009

Study information

Verified date October 2019
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.


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 information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Collagenase
Anterior shoulder capsule injection

Locations

Country Name City State
United States Dept. Orthopaedics, SUNY@Stony Brook Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Active elevation of the affected shoulder Active Elevation in degrees by goniometer measurement 30 days
Secondary Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function. Active and passive internal/external rotation in degrees by goniometer measure 30 days
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