Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160784
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2005-09-08
Brief Title:
Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis of the Shoulder - A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mechanisms 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
A second purpose of the study is to try and identify the mechanisms 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None