Feasibility, Usability and Preliminary Efficacy of Home-based FES Fro Adhesive Capsulitis
NCT ID: NCT07227662
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-12-01
2026-12-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Home-based FES
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.
Home 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.
Interventions
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Home 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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Kelly Westlake
Professor
Locations
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University of Maryland School of Medicine, Baltimore, Maryland
Baltimore, Maryland, United States
Countries
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Central Contacts
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References
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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.
Page 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.
Casarino 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.
Corbacho 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.
Kim 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.
Page P, Labbe A. Adhesive capsulitis: use the evidence to integrate your interventions. N Am J Sports Phys Ther. 2010 Dec;5(4):266-73.
Le 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.
Cao 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.
Sun 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.
Other Identifiers
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HP-00116646
Identifier Type: -
Identifier Source: org_study_id