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

Adhesive Capsulitis of the Shoulder Clinical Trial

Official title:

Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis of the Shoulder - A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160784
• Other study ID #: 44-1997
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: December 4, 2012
• Start date: March 1997
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis of the Shoulder
• Bursitis

Intervention

Procedure:
• Arthroscopy
Randomized placement into 2 groups; arthroscopic manipulation or home therapy
• Arthroscopic manipulation
Manipulation of shoulder performed during arthroscopy

Other:
• Home therapy
Shoulder exercise program performed at home that may increase shoulder function

Locations

Country	Name	City	State
United States	UF Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Secondary	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.		6 wk, 3 mo, 6 mo, 1 yr, 2yr	No