MedPath

Adhesive Capsulitis and Dynamic Splinting

Not Applicable
Terminated
Conditions
Adhesive Capsulitis
Registration Number
NCT01874821
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
5
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Efficacy6 months

The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York University

🇺🇸

New York, New York, United States

New York University
🇺🇸New York, New York, United States
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