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Dynamic Splinting for Patients With Adhesive Capsulitis

Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00873158
Acronym
DS-SDH
Enrollment
10
Registered
2009-04-01
Start date
2006-01-31
Completion date
Unknown
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis, ROM, Dynasplint

Brief summary

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

Detailed 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.

Interventions

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

Sponsors

McMurry University
CollaboratorOTHER
Dynasplint Systems, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of physical therapy treatments requiredthroughout trial
Weeks of Dynasplint treatmentthroughout trial

Secondary

MeasureTime frame
Shoulder Range Of Motioninitial consultation, first visit following injection, and monthly following injection
Sharp FAS Neck and Shoulderinitial consultation, immediatly prior to first treatment following injection, and monthly following injection
Disabilities of Arm, Hand, and Shoulder Questionnaireinitial visit, first visit following injection, and weekly until discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026