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

NCT00160784 | Completed Phase 4

• 1 other identifier: 44-1997
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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)

Conditions

Adhesive Capsulitis of the Shoulder

Outcome Measures

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.

  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.

  6 wk, 3 mo, 6 mo, 1 yr, 2yr

Study Arms (2)

Arthroscopic Manipulation

ACTIVE COMPARATOR

Manipulation of Shoulder performed during arthroscopy

Procedure: Arthroscopy; Procedure: Arthroscopic manipulation

Home exercise program

ACTIVE COMPARATOR

Shoulder exercise program performed at home to increase shoulder function

Other: Home therapy

Interventions

Arthroscopy PROCEDURE

Randomized placement into 2 groups; arthroscopic manipulation or home therapy

Also known as: No other names

Arthroscopic Manipulation

Arthroscopic manipulation PROCEDURE

Manipulation of shoulder performed during arthroscopy

Also known as: No other names

Arthroscopic Manipulation

Home therapy OTHER

Shoulder exercise program performed at home that may increase shoulder function

Also known as: No other names

Home exercise program

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Arthroscopy; Home Infusion Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Drug Therapy; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Thomas W. Wright, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 1997
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-11

Locations

US (1)