NCT07227662NARecruiting

Feasibility, Usability and Preliminary Efficacy of Home-based FES Fro Adhesive Capsulitis

University of Maryland, Baltimore

Start Date

6/1/2026

Completion Date

12/1/2026

Summary

The purpose of this study is to investigate the feasibility, usability and preliminary efficacy of a home-based Functional Electrical Stimulation(FES) in individuals with shoulder adhesive capsulitis. The main question it aims to answer is if combining home-based FES to usual therapy at the clinic will improve pain and improve function of the impaired shoulder.

Detailed Description

Individuals with shoulder adhesive capsulitis will be recruited. All participants will complete clinical assessments at 3 time points(baseline, 2 weeks into the intervention and 4 weeks after). Each participant will be asked to complete either one 60min or 2x30 min duration of FES daily for 4 weeks. The following assessments will be performed:Likert rating scales and open-ended questions,The Disabilities the Arm, Shoulder, and Hand (DASH) questionnaire,Active and passive shoulder range of motion (ROM) will be assessed using goniometric measurements for shoulder flexion, abduction, and external rotation,Pain rating at rest, night, and end range movement using a visual analogue scale (0-10 points)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age \> 18 years 2. Individuals diagnosed with shoulder adhesive capsulitis 3. Shoulder pain, limited shoulder mobility for more than 4 weeks, normal shoulder x-ray findings, and normal neurological exam 4. Can tolerate electrical stimulation Exclusion Criteria: 1. Presence of shoulder tumors or bone lesions 2. History of shoulder fracture or subluxation 3. History of shoulder surgery 4. Severe osteoporosis, 5. Rheumatic disease 6. Radiating pain from cervical radiculopathy 7. Participation in other clinical trial, and/or intraarticular steroid injections within 6 weeks

Interventions

DEVICE

Home based FES in combination with usual therapy

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Conditions

Shoulder Adhesive Capsulitis

Locations

University of Maryland School of Medicine, Baltimore, Maryland

Baltimore, Maryland 21201

United States