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NCT Number: NCT07227662

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

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.

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Key information

Conditions

Shoulder Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Medicine, Baltimore, Maryland

Baltimore, Maryland, 21201, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based FES in combination with usual therapy

Device

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 outcomes

  1. 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.

  2. 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

  1. Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score

    Time frame: Change from baseline DASH at 4 weeks

    The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire is a 30-item self-report measure assessing symptoms and functional limitations related to upper-limb musculoskeletal disorders. It also includes two optional 4-item modules (Work and Sports/Performing Arts). Each item is rated on a 5-point scale and converted to a total score ranging from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability. Changes in DASH total and optional module scores will be compared from baseline to 4 weeks.

  2. Change in Active and Passive Shoulder Range of Motion (ROM)

    Time frame: 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.

  3. Change in Shoulder Pain using Visual Analog Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjana Rao, PhD

CONTACT

[email protected]

4438256349

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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