Recruiting

FES

Sponsor:

University of Maryland, Baltimore

Code:

NCT07227662

Conditions

Shoulder Adhesive Capsulitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home based FES in combination with usual therapy

Study Details

Brief 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

Study ID

NCT07227662

Start date

Jun 1, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: Home-based FES

The intervention will include home use of Genesis Flex FES device alongside usual rehabilitation care. Participant education in Genesis FES use will be conducted during the baseline assessment session. FES parameters will be initially adjusted at the lowest possible current for patient comfort with the constraint that they should not elicit a tetanic contraction. FES will be provided via two self adhesive electrodes attached across shoulder joint.A shoulder harness adjustable neoprene padding will be provided to enable anatomical contouring for patient comfort and support for positioning of stimulator and electrodes to the affected shoulder.

Interventions

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.

Primary outcome measure

  • Participant Acceptability and Satisfaction [ Time Frame: At the end of 4 weeks ]
  • Usability of the FES device for home-based use [ Time Frame: At the end of 4 weeks ]

Central Contacts and Locations

Central contacts

Sanjana Rao, PhD

4438256349sanjana.rao@som.umaryland.edu

Locations

University of Maryland School of Medicine, Baltimore, Maryland

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 25, 2026

Last verified

May, 2026

Keywords

  • Functional Electrical Stimulation
  • Home-based
  • Shoulder Adhesive Capsulitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.