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

D

Dynasplint Systems.

Status

Terminated

Conditions

Adhesive Capsulitis

Treatments

Device: Dynasplint

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00873158
Shoulder 100

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

40 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Physical Therapy Group
No Intervention 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
Dynasplint Group
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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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