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Completed

NCT Number: NCT00160784

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

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)

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Key information

Conditions

Adhesive Capsulitis of the Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Arthroscopy

Procedure

Randomized placement into 2 groups; arthroscopic manipulation or home therapy

Other names: No other names

Arthroscopic manipulation

Procedure

Manipulation of shoulder performed during arthroscopy

Other names: No other names

Home Therapy

Other

Shoulder exercise program performed at home that may increase shoulder function

Other names: No other names

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2005
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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