Dynamic Splinting for Patients With Adhesive Capsulitis
Not Applicable
Terminated
- Conditions
- Adhesive Capsulitis
- Interventions
- Device: Dynasplint
- 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.
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
- Arm && Interventions
Group Intervention Description Dynasplint Group Dynasplint Along with standard manual physical therapy, patients will have a stretching device (Dynasplint) used in rehabilitation to regain ROM in stiff joints. Patients will use this device 20-30 minutes 2 times per day at home.
- 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