A Phase 4 interventional study of Arthroscopy and Arthroscopic manipulation in Adhesive Capsulitis of the Shoulder, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-05.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 58 is above the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
Manipulation of Shoulder performed during arthroscopy
Procedure: Arthroscopy · Procedure: Arthroscopic manipulation
Shoulder exercise program performed at home to increase shoulder function
Other: Home therapy
Randomized placement into 2 groups; arthroscopic manipulation or home therapy
Also known as: No other names
Manipulation of shoulder performed during arthroscopy
Also known as: No other names
Shoulder exercise program performed at home that may increase shoulder function
Also known as: No other names
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.
Time frame: 2 years
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.
Time frame: 6 wk, 3 mo, 6 mo, 1 yr, 2yr
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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