Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Stony Brook University

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Adhesive Capsulitis Frozen Shoulder

Interventions

CollagenaseDRUG

Anterior shoulder capsule injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Active elevation of the affected shoulder

Active Elevation in degrees by goniometer measurement

Time frame: 30 days

Secondary Outcomes

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

Time frame: 30 days

Data from ClinicalTrials.gov

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