Dynamic Splinting for Patients With Adhesive Capsulitis (DS-SDH)

August 8, 2013 updated by: Dynasplint Systems, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Solana Beach, California, United States, 92075
        • Gaspar Physical Therapy
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education Institute
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Physical Therapy Group
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of physical therapy treatments required
Time Frame: throughout trial
throughout trial
Weeks of Dynasplint treatment
Time Frame: throughout trial
throughout trial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynasplint Systems, Inc.

Collaborators

McMurry University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (ESTIMATE)

April 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shoulder 100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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