Adhesive Capsulitis and Dynamic Splinting

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.

Detailed Description
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This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.

Official Title
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Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Device: Dynasplint
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º Duration from onset less than 12 months. Pain that is worsened by moving the arm in that direction Exclusion Criteria: Any previous shoulder surgery. Brachial plexus injuries Neurologically mediated pain and fibromatosis-like contracture Concomitant neurologic complaints or abnormalities Glenohumeral impingement or mechanical blockage Oncological process affecting the shoulder Previous total mastectomy Glenohumeral arthritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynasplint<br>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. | Device: Dynasplint<br>* Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen<br>* Other names: Shoulder;Other: Standard of Care<br>* The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.<br>|
| Other: Control<br>Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention | Other: Standard of Care<br>* The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint