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.
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
Presence of shoulder tumors or bone lesions
History of shoulder fracture or subluxation
History of shoulder surgery
Severe osteoporosis,
Single group
Home based FES in combination with usual therapy
DeviceParticipants 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.
Participant Acceptability and Satisfaction
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
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.
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score
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.
Change in Active and Passive Shoulder Range of Motion (ROM)
Active and passive shoulder ROM will be assessed using goniometric measurements for shoulder flexion, abduction, and external rotation.
Change in Shoulder Pain using Visual Analog Scale
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.
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