Adhesive Capsulitis and Dynamic Splinting

D

Dynasplint Systems.

Status

Terminated

Conditions

Adhesive Capsulitis

Treatments

Other: Standard of Care
Device: Dynasplint

Study type

Interventional

Funder types

Industry

Identifiers

NCT01874821
2010.005
SHD (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Dynasplint
Experimental group
Description:
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.
Treatment:
Device: Dynasplint
Other: Standard of Care
Control
Other group
Description:
Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Treatment:
Other: Standard of Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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