Dynamic Splinting for Patients With Adhesive Capsulitis

Not Applicable

Terminated

• Conditions: Adhesive Capsulitis

• Registration Number: NCT00873158
• Lead Sponsor: Dynasplint Systems, Inc.

Brief Summary

The purpose of this study is to compare two treatments for adhesive capsulitis.

Detailed Description

The purpose of this study is to examine the effects of two treatment regimens for adhesive capsulitis: dynamic splinting and/or manual physical therapy.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosis of idiopathic adhesive capsulitis
• greater than 50% limitation in active flexion, internal rotation, or external rotation
• Tight GHJ capsule in at least 2 directions
• Capsular end-feel primarily limits ROM
• Age 40- 64
• Normal X-Rays

Exclusion Criteria

• Acute adhesive capsulitis
• History of Diabetes Mellitus
• Evidence of a cuff tear
• Recent history of trauma
• Evidence of glenohumeral DJD
• History of shoulder surgery
• Calcification of tendonitis demonstrated on a current X-Ray
• Abnormal X-Ray
• Cervical Radiculopathy/brachial plexus lesions
• Less than 2+/5 muscle strength during mid-line manual muscle testing
• Muscle Atrophy
• Presence of associated systematic conditions
• History of prior therapy for current condition
• Manipulation under anesthesia
• Non compliance
• Shoulder-Hand syndrome, Complex Regional Pain Syndrome
• History of prior injections for the current problem
• Patient receiving worker's compensation
• Shoulder symptoms with cervical provocative testing
• Positive X-ray findings in the acromioclavicular or sternoclavicular joints
• Abnormal physical signs or symptoms in the A-C or S-C joint

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of physical therapy treatments required	throughout trial
Weeks of Dynasplint treatment	throughout trial

Secondary Outcome Measures

Name	Time	Method
Shoulder Range Of Motion	initial consultation, first visit following injection, and monthly following injection
Sharp FAS Neck and Shoulder	initial consultation, immediatly prior to first treatment following injection, and monthly following injection
Disabilities of Arm, Hand, and Shoulder Questionnaire	initial visit, first visit following injection, and weekly until discharge

Trial Locations

Locations (3)

Gaspar Physical Therapy; 🇺🇸 Solana Beach, California, United States

Andrews Research & Education Institute; 🇺🇸 Gulf Breeze, Florida, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States