Adhesive Capsulitis and Dynamic Splinting

Dynasplint Systems, Inc.5 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adhesive Capsulitis

Interventions

DynasplintDEVICE

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

Standard of CareOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University

New York, New York, United States

Outcomes

Primary Outcomes

Efficacy

The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).

Time frame: 6 months

Data from ClinicalTrials.gov

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