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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Sanjana Rao, PhD contact

4438256349

sanjana.rao@som.umaryland.edu

United States1 site, 1 recruiting

  • University of Maryland School of Medicine, Baltimore, Maryland

    Baltimore, Maryland, 21201

    Recruiting

Other trials in United States

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)

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 groups in NCT07227662
Study groupRoleWhat they receive
Home-based FESOtherThe 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted13 Nov 2025
  2. Study start1 Jun 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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 33326025

  • 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.

    PubMed 25271097

  • 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.

    PubMed 23636125

  • 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.

    PubMed 34420365

  • 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.

    PubMed 30952550

  • 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.

    PubMed 21655385

  • 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.

    PubMed 28405218

  • 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.

    PubMed 35795630

  • 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.

    PubMed 38956312

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sanjana Rao, PhD (4438256349, sanjana.rao@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Acceptability and Satisfaction (time frame: At the end of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07227662, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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