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

This study is currently recruiting participants.
Verified May 2013 by Dynasplint Systems, Inc.
Sponsor:
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00873158
First received: March 31, 2009
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Adhesive Capsulitis
 Device: Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Number of physical therapy treatments required [ Time Frame: throughout trial ] [ Designated as safety issue: No ]
  • Weeks of Dynasplint treatment [ Time Frame: throughout trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder Range Of Motion [ Time Frame: initial consultation, first visit following injection, and monthly following injection ] [ Designated as safety issue: No ]
  • Sharp FAS Neck and Shoulder [ Time Frame: initial consultation, immediatly prior to first treatment following injection, and monthly following injection ] [ Designated as safety issue: No ]
  • Disabilities of Arm, Hand, and Shoulder Questionnaire [ Time Frame: initial visit, first visit following injection, and weekly until discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873158

Contacts
Contact: Paul Gaspar, DPT 858.794.995 gasparPT@hotmail.com
Contact: Buck Willis, PhD 512-297-1833 bwillis@dynasplint.com

Locations
United States, California
Gaspar Physical Therapy Recruiting
Solana Beach, California, United States, 92075
Contact: Paul Gaspar, DPT     858-794-9995     gasparpt@hotmail.com    
Principal Investigator: Paul Gaspar, DPT            
United States, Florida
Andrews Research & Education Institute Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Melissa Davis, RN     850-916-8591     MelissaM.Davis@bhcpns.org    
Principal Investigator: Joshua G Hackle, MD            
United States, Pennsylvania
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Rebecca Young     814-272-3691     ryoung@uoc.com    
Principal Investigator: Paul R Sensiba, MD            
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
Investigators
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00873158     History of Changes
Other Study ID Numbers: Shoulder 100
Study First Received: March 31, 2009
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
Adhesive Capsulitis
ROM
Dynasplint

Additional relevant MeSH terms:
Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis

ClinicalTrials.gov processed this record on May 21, 2013