Adhesive Capsulitis and Dynamic Splinting

Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01874821

Enrollment

Registered

2013-06-11

Start date

2013-01-31

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

Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint

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.

Interventions

DEVICEDynasplint

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

OTHERStandard of Care

The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	6 months	The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026