Feasibility, Usability and Preliminary Efficacy of Home-based FES Fro Adhesive Capsulitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Participant Acceptability and Satisfaction
Study Overview
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.
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •Individuals diagnosed with shoulder adhesive capsulitis
- •Shoulder pain, limited shoulder mobility for more than 4 weeks, normal shoulder x-ray findings, and normal neurological exam
- •Can tolerate electrical stimulation
Exclusion Criteria
- •Presence of shoulder tumors or bone lesions
- •History of shoulder fracture or subluxation
- •History of shoulder surgery
- •Severe osteoporosis,
- •Rheumatic disease
- •Radiating pain from cervical radiculopathy
- •Participation in other clinical trial, and/or intraarticular steroid injections within 6 weeks
Arms & Interventions
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.
Intervention: Home based FES in combination with usual therapy (Device)
Outcomes
Primary Outcomes
Participant Acceptability and Satisfaction
Time Frame: At the end of 4 weeks
Participant-reported satisfaction, comfort, and ease of use assessed using a 5-point Likert scale and open-ended qualitative feedback.A Likert scale is a rating scale used in surveys to measure opinions, attitudes,and perceptions by asking respondents to indicate their level of agreement or disagreement with a statement. It consists of a series of statements with a symmetric range of response options, such as a five-point scale from 0="Strongly Disagree" to 5="Strongly Agree". This method allows for the collection of quantitative data to analyze subjective experiences.
Usability of the FES device for home-based use
Time Frame: At the end of 4 weeks
Percentage of participants able to correctly and independently use the portable FES device for ≥80% of prescribed home sessions, as verified by device logs and participant self-report.
Secondary Outcomes
- Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score(Change from baseline DASH at 4 weeks)
- Change in Active and Passive Shoulder Range of Motion (ROM)(Change from baseline ROM at 4 weeks)
- Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score(Change from baseline DASH at 4 weeks)
- Change in Active and Passive Shoulder Range of Motion (ROM)(Change from baseline ROM at 4 weeks)
- Change in Shoulder Pain using Visual Analog Scale(Change from Baseline VAS at 4 weeks)
Investigators
Kelly Westlake
Professor
University of Maryland, Baltimore