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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Maryland, Baltimore • ClinicalTrials.gov ID: NCT07227662

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Home based FES in combination with usual therapy (Device)
    Participants diagnosed with shoulder adhesive capsulitis and being treated at a local physical and occupational therapy outpatient clinic will be deemed eligible for inclusion in the study.The intervention will include home use of Genesis Flex FES device alongside usual rehabilitation care. Usual care therapy may consist of manual therapy, hot packs, transcutaneous electrical nerve stimulation, ultrasound treatments, daily home-based shoulder exercises, and/or acetaminophen for pain, which will be documented.

Eligibility criteria

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

Conditions

Shoulder Adhesive Capsulitis

Locations

  • University of Maryland School of Medicine, Baltimore, Maryland — Baltimore, Maryland, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record