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Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis
This study is currently recruiting participants.
Verified by University of Florida, May 2008
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00160784
  Purpose

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)


Condition Intervention Phase
Adhesive Capsulitis of the Shoulder
Procedure: Arthroscopy
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis of the Shoulder - A Prospective Randomized Study

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • At the end of two years, the SPADI test, Range of Motion test and Strength test will be used to determine the effect of the intervention.

Secondary Outcome Measures:
  • The SPADI, Range of Motion and Strength test will be taken at six weeks, three months, six months, one year and two years to evaluate the condition of the affected shoulder.

Estimated Enrollment: 70
Study Start Date: March 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160784

Contacts
Contact: Thomas W. Wright, MD 352-273-7002 wrightw@ortho.ufl.edu

Locations
United States, Florida
UF Orthopaedics and Sports Medicine Institute Recruiting
Gainesville, Florida, United States, 32611
Contact: Darlene E. Bailey     352-273-7073     bailede@ortho.ufl.edu    
Principal Investigator: Thomas W. Wright, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Thomas W. Wright, MD University of Florida
  More Information

Study ID Numbers: 44-1997
Study First Received: September 8, 2005
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00160784  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Musculoskeletal Diseases
Joint Diseases
Bursitis

ClinicalTrials.gov processed this record on January 16, 2009