Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Adhesive Capsulitis Clinical Trial

Official title:

Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00261196
• Other study ID #: Shoulder 202
• Status: Withdrawn
• Phase: Phase 2
• 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
• 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Frozen Shoulder

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