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Trial record 25 of 51 for:    "Frozen Shoulder"

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

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ClinicalTrials.gov Identifier: NCT00160784
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Florida

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)

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of the Shoulder Procedure: Arthroscopy Procedure: Arthroscopic manipulation Other: Home therapy Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis of the Shoulder - A Prospective Randomized Study
Study Start Date : March 1997
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Active Comparator: Arthroscopic Manipulation
Manipulation of Shoulder performed during arthroscopy
Procedure: Arthroscopy
Randomized placement into 2 groups; arthroscopic manipulation or home therapy
Other Name: No other names

Procedure: Arthroscopic manipulation
Manipulation of shoulder performed during arthroscopy
Other Name: No other names

Active Comparator: Home exercise program
Shoulder exercise program performed at home to increase shoulder function
Other: Home therapy
Shoulder exercise program performed at home that may increase shoulder function
Other Name: No other names




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160784


Locations
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United States, Florida
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Thomas W. Wright, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00160784     History of Changes
Other Study ID Numbers: 44-1997
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases