Dynamic Splinting for Patients With Adhesive Capsulitis

Study Overview
=================
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.

Official Title
-----------------
Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis

Conditions
-----------------
Adhesive Capsulitis

Intervention / Treatment
-----------------
* Device: Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physical Therapy Group<br>Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention | |
| Experimental: Dynasplint Group<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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physical therapy treatments required |  | throughout trial | 
| Weeks of Dynasplint treatment |  | throughout trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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