Adhesive Capsulitis and Dynamic Splinting

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)

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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