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

NCT07227662 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Shoulder Adhesive Capsulitis

Interventions

DEVICE

Home based FES in combination with usual therapy

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227662 on ClinicalTrials.gov