Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00261196

Enrollment

Registered

2005-12-02

Start date

2006-01-31

Completion date

2009-01-31

Last updated

2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis, Frozen Shoulder

Keywords

Frozen Shoulder

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.

Interventions

DRUGCollagenase

Anterior shoulder capsule injection

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Active elevation of the affected shoulder	30 days	Active Elevation in degrees by goniometer measurement

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026