NCT07513753Not yet recruiting
Focal Vibration Therapy in Post-stroke Shoulder Pain
Efficacy of Focal Vibrational Therapy in Reducing Post-stroke Shoulder Pain: a Double-blind, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- University of Foggia
- Diseases
- Stroke
- NCT number
- NCT07513753
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2026 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
Other illness
- 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.
Other
- Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università degli Studi di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.