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