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Trial record 51 of 51 for:    "Frozen Shoulder"

Adhesive Capsulitis and Dynamic Splinting

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ClinicalTrials.gov Identifier: NCT01874821
Recruitment Status : Terminated (Unrelated to trial)
First Posted : June 11, 2013
Last Update Posted : August 12, 2013
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

Brief Summary:
The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Device: Dynasplint Other: Standard of Care Not Applicable

Detailed Description:
This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: Dynasplint
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
Other Name: Shoulder

Other: Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.

Control
Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Other: Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 6 months ]
    The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
  • Duration from onset less than 12 months.
  • Pain that is worsened by moving the arm in that direction

Exclusion Criteria:

  • Any previous shoulder surgery.
  • Brachial plexus injuries
  • Neurologically mediated pain and fibromatosis-like contracture
  • Concomitant neurologic complaints or abnormalities
  • Glenohumeral impingement or mechanical blockage
  • Oncological process affecting the shoulder
  • Previous total mastectomy
  • Glenohumeral arthritis

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 ClinicalTrials.gov identifier (NCT number): NCT01874821


Locations
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United States, New York
New York University
New York, New York, United States, 10003
Sponsors and Collaborators
Dynasplint Systems, Inc.

Publications:
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Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01874821     History of Changes
Other Study ID Numbers: 2010.005
SHD ( Other Identifier: Dynasplint )
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases