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

NCT07227662 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HP-00116646
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Adhesive Capsulitis

Keywords

Functional Electrical Stimulation; Home-based; Shoulder Adhesive Capsulitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the end of 4 weeks

Secondary Outcomes (3)

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

  Change from baseline DASH at 4 weeks

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

  Change from baseline ROM at 4 weeks

• Change in Shoulder Pain using Visual Analog Scale

  Change from Baseline VAS at 4 weeks

Study Arms (1)

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.

Device: Home based FES in combination with usual therapy

Interventions

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.

Home-based FES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine, Baltimore, Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (11)

• 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

  BACKGROUND

• 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.

  PMID: 33326025 BACKGROUND

• 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.

  PMID: 25271097 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23636125 BACKGROUND

• 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.

  PMID: 34420365 BACKGROUND

• 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.

  PMID: 30952550 BACKGROUND

• 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.

  PMID: 21655385 BACKGROUND

• 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.

  PMID: 28405218 BACKGROUND

• 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.

  PMID: 35795630 BACKGROUND

• 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.

  PMID: 38956312 BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Sanjana Rao, PhD

CONTACT

4438256349; sanjana.rao@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: November 13, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)