Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

October 1, 2019 updated by: Marie Badalamente, Stony Brook University
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Dept. Orthopaedics, SUNY@Stony Brook

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagenase
Collagenase Injection
Drug: Collagenase
Anterior shoulder capsule injection
Other Names:
  • Xiaflex
Placebo Comparator: Placebo
Placebo Injection
Drug: Collagenase
Anterior shoulder capsule injection
Other Names:
  • Xiaflex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Time Frame: 30 days
Active and passive internal/external rotation in degrees by goniometer measure
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shoulder 202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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