Shoulder Adhesive Capsulitis
Conditions
Keywords
Functional Electrical Stimulation, Home-based, Shoulder Adhesive Capsulitis
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)
Interventions
DEVICEHome based FES in combination with usual therapy
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.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score | 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. |
| 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 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. |
Countries
United States
Contacts
CONTACTSanjana Rao, PhD
Outcome results
None listed