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Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis

NCT ID: NCT00160784

Last Updated: 2012-12-05

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to compare two treatments used for treating frozen shoulder which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to see if one relives pain and improves shoulder motion more quickly. The other purpose is to try and understand what causes frozen shoulder. For this purpose, tissue will be taken from the shoulder during surgery and studied for the presence and level of a protein called cytokine (Connective Tissue Growth Factor)

Detailed Description

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Adhesive capsulitis of the shoulder is a relatively common entity which is poorly understood and produces a significant amount of morbidity in afflicted patients. The natural history of adhesive capsulitis is only just beginning to be understood. It is a self-limiting disease, but may take 18 to 36 months to resolve. During that time, individuals can suffer a significant amount of pain and miss a large amount of work. Many surgeons have treated this process with early manipulation with the outcome never being reported in a prospective manner. Some authors have advocated conservative non-operative treatment, knowing the natural history in most of these shoulders will be near resolution. The primary purpose of this study is to examine in a prospective randomized manner the results of continuous non-operative management versus arthroscopic capsulectomy. This study will determine if operative intervention with an arthroscopic capsulectomy can shorten the natural history of adhesive capsulitis, and give comparable results with non-operative management at final follow-up of 2 years.

A second purpose of the study is to try and identify the mechanism(s) responsible for adhesive capsulitis. Recent research suggests that cytokines and connective tissue growth factor (CTGF) may be involved in the inflammatory and fibrotic processes. The second purpose of this study involves histological and immunohistochemical analysis of capsular and synovial tissue routinely removed during an arthroscopic capsulectomy. Tissue taken from subjects in the surgical treatment group will be compared to tissue from patients undergoing an arthroscopic capsulectomy for reasons other than adhesive capsulitis (control group). Location and concentration of CTGF will be compared between these groups. If levels of CTGF are elevated in the treatment group as hypothesized, development and testing of agents that specifically reduce the action of CTGF may be indicated. A specific agent blocking CTGF has been developed and is nearing clinical trials.

Conditions

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Adhesive Capsulitis of the Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arthroscopic Manipulation

Manipulation of Shoulder performed during arthroscopy

Group Type ACTIVE_COMPARATOR

Arthroscopy

Intervention Type PROCEDURE

Randomized placement into 2 groups; arthroscopic manipulation or home therapy

Arthroscopic manipulation

Intervention Type PROCEDURE

Manipulation of shoulder performed during arthroscopy

Home exercise program

Shoulder exercise program performed at home to increase shoulder function

Group Type ACTIVE_COMPARATOR

Home therapy

Intervention Type OTHER

Shoulder exercise program performed at home that may increase shoulder function

Interventions

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Arthroscopy

Randomized placement into 2 groups; arthroscopic manipulation or home therapy

Intervention Type PROCEDURE

Arthroscopic manipulation

Manipulation of shoulder performed during arthroscopy

Intervention Type PROCEDURE

Home therapy

Shoulder exercise program performed at home that may increase shoulder function

Intervention Type OTHER

Other Intervention Names

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No other names No other names No other names

Eligibility Criteria

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Inclusion Criteria

* frozen shoulder (pain and stiffness) experienced for at least four months and treatment has not helped.

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas W. Wright, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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44-1997

Identifier Type: -

Identifier Source: org_study_id