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

Dynasplint Systems, Inc.3 sites in 1 country10 target enrollmentJanuary 2006

ConditionsAdhesive Capsulitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adhesive Capsulitis
Sponsor: Dynasplint Systems, Inc.
Enrollment: 10
Locations: 3
Primary Endpoint: Number of physical therapy treatments required
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

January 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dynasplint Systems, Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of physical therapy treatments required

Time Frame: throughout trial

Weeks of Dynasplint treatment

Time Frame: throughout trial

Secondary Outcomes

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)