Focal Vibration Therapy in Post-stroke Shoulder Pain
Not yet recruitingNot applicableNCT07513753
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy of Focal Vibrational Therapy in Reducing Post-stroke Shoulder Pain: a Double-blind, Randomized Controlled Trial
- Conditions
- Stroke
- Hemiplegic Shoulder Pain
- Chronic Stroke Survivors
- Interventions
- Device: Multimodal Focal Vibration Therapy (FVT)
- Other: Standard Rehabilitation Program
- Sponsor
- University of Foggia
- Start date
- 2026-04-01
- Primary completion
- 2026-10-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07513753