Shoulder Adhesive CapsulitisNCT07227662
Feasibility, Usability and Preliminary Efficacy of Home-based FES Fro Adhesive Capsulitis
A study testing Home based FES in combination with usual therapy in people with Shoulder Adhesive Capsulitis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Adhesive Capsulitis
- What is being tested?
- Home based FES in combination with usual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland School of Medicine, Baltimore, Maryland
Baltimore, Maryland, 21201
About this study
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.
Read the 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)
- Conditions
- Shoulder Adhesive Capsulitis
- Being tested
- Home based FES in combination with usual therapy
- Keywords
- Functional Electrical Stimulation, Home-based, Shoulder Adhesive Capsulitis
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based FES in combination with usual therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based FES | Other | 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. Receives: Device: Home based FES in combination with usual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of 4 weeks
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.
Measured: At the end of 4 weeks
Secondary outcomes (3)
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.
Measured: Change from baseline DASH at 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.
Measured: Change from baseline ROM at 4 weeks
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.
Measured: Change from Baseline VAS at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Westlake, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227662
- Sponsor's protocol ID
- HP-00116646
- Status last verified
- May 2026
- First submitted
- 27 Oct 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rehman ZI, Khan S, Abbas M. Effect of FES with and without Mulligan's technique in adhesive capsulitis. J Health Rehabil Res. 2024;4(3):Article 1408
Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
PubMed 33326025Page MJ, Green S, Kramer S, Johnston RV, McBain B, Buchbinder R. Electrotherapy modalities for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014 Oct 1;2014(10):CD011324. doi: 10.1002/14651858.CD011324.
PubMed 25271097Casarino V, Ciatti P, Martini A. Weighted spectral cluster bounds and a sharp multiplier theorem for ultraspherical Grushin operators. International Mathematics Research Notices. 2022;2022(12):9209-9274. doi:10.1093/imrn/rnab007
Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.
PubMed 23636125Corbacho B, Brealey S, Keding A, Richardson G, Torgerson D, Hewitt C, McDaid C, Rangan A; UK FROST trial team. Cost-effectiveness of surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder : an economic evaluation of the UK FROST trial. Bone Jt Open. 2021 Aug;2(8):685-695. doi: 10.1302/2633-1462.28.BJO-2021-0075.R1.
PubMed 34420365Kim DH, Kim YS, Kim BS, Sung DH, Song KS, Cho CH. Is frozen shoulder completely resolved at 2 years after the onset of disease? J Orthop Sci. 2020 Mar;25(2):224-228. doi: 10.1016/j.jos.2019.03.011. Epub 2019 Apr 2.
PubMed 30952550Page P, Labbe A. Adhesive capsulitis: use the evidence to integrate your interventions. N Am J Sports Phys Ther. 2010 Dec;5(4):266-73.
PubMed 21655385Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.
PubMed 28405218Cao W, Chen J, Pu J, Fan Y, Cao Y. Risk Factors for the Onset of Frozen Shoulder in Middle-Aged and Elderly Subjects Within 1 Year of Discharge From a Hospitalization That Involved Intravenous Infusion: A Prospective Cohort Study. Front Med (Lausanne). 2022 Jun 20;9:911532. doi: 10.3389/fmed.2022.911532. eCollection 2022.
PubMed 35795630Sun G, Li Q, Yin Y, Fu W, He K, Pen X. Risk factors and predictive models for frozen shoulder. Sci Rep. 2024 Jul 3;14(1):15261. doi: 10.1038/s41598-024-66360-y.
PubMed 38956312