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Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Primary Purpose

Adhesive Capsulitis, Frozen Shoulder

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Collagenase
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Frozen Shoulder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Dept. Orthopaedics, SUNY@Stony Brook

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Collagenase

Placebo

Arm Description

Collagenase Injection

Placebo Injection

Outcomes

Primary Outcome Measures

Active elevation of the affected shoulder
Active Elevation in degrees by goniometer measurement

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2005
Last Updated
October 1, 2019
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00261196
Brief Title
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Official Title
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
IND moved to sponsor.
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, Frozen Shoulder
Keywords
Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collagenase
Arm Type
Experimental
Arm Description
Collagenase Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Injection
Intervention Type
Drug
Intervention Name(s)
Collagenase
Other Intervention Name(s)
Xiaflex
Intervention Description
Anterior shoulder capsule injection
Primary Outcome Measure Information:
Title
Active elevation of the affected shoulder
Description
Active Elevation in degrees by goniometer measurement
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Description
Active and passive internal/external rotation in degrees by goniometer measure
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie A Badalamente, PhD
Organizational Affiliation
Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Orthopaedics, SUNY@Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

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