Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Dynasplint Systems, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Dynasplint (Device)
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.
Intervention: Standard of Care (Other)
Control
Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported