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

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Shoulder Adhesive Capsulitis

Treatments: Device: Home based FES in combination with usual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07227662

HP-00116646

Details and patient eligibility

About

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.

Full 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)

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Home-based FES

Other group

Description:

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.

Treatment:

Device: Home based FES in combination with usual therapy