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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00873158
Recruitment Status : Terminated (Unrelated to trial)
First Posted : April 1, 2009
Last Update Posted : August 12, 2013
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

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

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Device: Dynasplint Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis
Study Start Date : January 2006
Estimated Primary Completion Date : January 2014

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

Primary Outcome Measures :
  1. Number of physical therapy treatments required [ Time Frame: throughout trial ]
  2. Weeks of Dynasplint treatment [ Time Frame: throughout trial ]

Secondary Outcome Measures :
  1. Shoulder Range Of Motion [ Time Frame: initial consultation, first visit following injection, and monthly following injection ]
  2. Sharp FAS Neck and Shoulder [ Time Frame: initial consultation, immediatly prior to first treatment following injection, and monthly following injection ]
  3. Disabilities of Arm, Hand, and Shoulder Questionnaire [ Time Frame: initial visit, first visit following injection, and weekly until discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00873158

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United States, California
Gaspar Physical Therapy
Solana Beach, California, United States, 92075
United States, Florida
Andrews Research & Education Institute
Gulf Breeze, Florida, United States, 32561
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
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Study Director: Buck Willis, PhD Dynasplint Systems, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dynasplint Systems, Inc. Identifier: NCT00873158    
Other Study ID Numbers: Shoulder 100
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by Dynasplint Systems, Inc.:
Adhesive Capsulitis
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases