Focal Vibration Therapy in Post-stroke Shoulder Pain
Italy60 participantsStarted 2026-04-01
Plain-language summary
Hemiplegic Shoulder Pain (HSP) is a common and disabling complication after stroke, negatively affecting upper limb function, participation in rehabilitation, and quality of life. Despite the widespread use of conservative and physical therapies, evidence supporting the efficacy of specific non-invasive neuromodulation techniques remains limited.
Focal Vibration Therapy (FVT) is a non-invasive physical modality that delivers localized mechanical vibration to targeted muscles or tendons and may modulate pain, muscle tone, and proprioception through frequency-dependent mechanisms.
This randomized controlled trial aims to evaluate the efficacy of a multimodal FVT protocol, in addition to standard rehabilitation, compared with a sham intervention plus standard rehabilitation, in reducing pain in patients with chronic post-stroke Hemiplegic Shoulder Pain.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Ischemic or hemorrhagic stroke confirmed by CT or MRI
* Chronic post-stroke phase (≥ 6 months from event)
* Presence of hemiplegic shoulder pain (NRS ≥ 4)
* Preserved cognitive function sufficient to provide informed consent
Exclusion Criteria:
* Severe cognitive impairment or language deficits (e.g., severe aphasia) that prevent understanding of study procedures or reliable reporting of pain (e.g., inability to complete NRS or questionnaires).
* Severe neglect, apraxia, or disorders of consciousness that interfere with participation in rehabilitation or outcome assessments.
* Pre-existing shoulder pathology of the affected side unrelated to stroke (e.g., full-thickness rotator cuff tear, advanced glenohumeral osteoarthritis, inflammatory arthritis, prior shoulder surgery).
* Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment.
* Botulinum toxin injections to shoulder upper limb muscles within the last 3-4 months prior to enrollment .
* Current treatment with other experimental or non-conventional physical therapies for shoulder pain during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Assessed by Numerical Rating Scale (NRS)
Timeframe: From baseline (Day 0) to the Day 15 (end of treatment)