Focal Vibration Therapy in Post-stroke Shoulder Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Foggia
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Multimodal Focal Vibration Therapy (FVT)
- Standard Rehabilitation Program
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov