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

Not Applicable

Not yet recruiting

• Conditions: Shoulder Adhesive Capsulitis

• Registration Number: NCT07227662
• Lead Sponsor: University of Maryland, Baltimore

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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-11-10
• Last Update Submitted: 2025-11-10
• Study First Posted: 2025-11-13
• Last Update Posted: 2025-11-13
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participant Acceptability and Satisfaction	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	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 Outcome Measures

Name	Time	Method
Change in Active and Passive Shoulder Range of Motion (ROM)	Change from baseline ROM at 4 weeks	Active and passive shoulder ROM will be assessed using goniometric measurements for shoulder flexion, abduction, and external rotation.
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score	Change from baseline DASH at 4 weeks	The DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. It has two, 4-item, optional modules used to measure symptoms and function. Total and subscale scores will be compared from baseline to 4 weeks.
Change in Shoulder Pain using Visual Analog Scale	Change from Baseline VAS at 4 weeks	Change in shoulder pain intensity assessed using a 10-point Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain imaginable. Pain will be rated at rest, during the night, and at end-range shoulder movement.

Trial Locations

Locations (1)

University of Maryland School of Medicine, Baltimore, Maryland; 🇺🇸 Baltimore, Maryland, United States