Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Adhesive Capsulitis Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Collagenase

Collagenase Injection

Group Type EXPERIMENTAL

Collagenase

Intervention Type DRUG

Anterior shoulder capsule injection

Placebo

Placebo Injection

Group Type PLACEBO_COMPARATOR

Collagenase

Intervention Type DRUG

Anterior shoulder capsule injection

Interventions

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Collagenase

Anterior shoulder capsule injection

Intervention Type DRUG

Other Intervention Names

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Xiaflex

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No