[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632443":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":45,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Foggia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Focal Vibration Therapy + Standard Rehabilitation","EXPERIMENTAL","Participants allocated to the experimental group will receive an integrated treatment consisting of a standardized physiokinesitherapy program followed by active multimodal focal vibration therapy applied to shoulder and peri-scapular muscles involved in hemiplegic shoulder pain.",[13,14],"Device: Multimodal Focal Vibration Therapy (FVT)","Other: Standard Rehabilitation Program",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham Focal Vibration Therapy + Standard Rehabilitation","SHAM_COMPARATOR","Participants allocated to the control group will receive the same standardized physiokinesitherapy program followed by a sham focal vibration procedure identical in duration and application setting, but without delivery of effective vibratory stimulation.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Multimodal Focal Vibration Therapy (FVT)","Participants in the experimental group will receive multimodal Focal Vibration Therapy (FVT) delivered using a medical vibration device, in addition to standard post-stroke shoulder rehabilitation. FVT will be applied to selected peri-scapular and shoulder muscles involved in pain generation and motor impairment, according to a standardized protocol. Each treatment session consists of two integrated phases.\n\nPhysiokinesitherapy Phase (30 minutes):\n\nParticipants will undergo a standardized rehabilitation protocol targeting recovery of the hemiplegic shoulder.\n\nFocal Vibration Therapy Phase (25 minutes):\n\nFour dome-shaped transducers will be applied directly to the skin over the muscle bellies of Pectoralis Major, Infraspinatus, Middle Deltoid, and Upper Trapezius. The device will deliver a pre-programmed sequence of vibrations consisting of:\n\n* 5 minutes at 35 Hz for superficial analgesia\n* 10 minutes at 100 Hz for muscle tone reduction\n* 10 minutes at 200 Hz for deep analgesia",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Rehabilitation Program","All participants will undergo a standardized post-stroke shoulder rehabilitation program, including passive, active-assisted, and active exercises aimed at pain reduction, range of motion recovery, and functional improvement of the affected upper limb. Each session will consist of the same two phases as the experimental group.\n\nPhysiokinesitherapy Phase (30 minutes):\n\nIdentical to that administered in the experimental group.\n\nSham Procedure Phase (25 minutes):\n\nFour transducers will be positioned on the same shoulder muscle sites as in the experimental group but connected to inactive outputs of the device, delivering no therapeutic vibration. To maintain participant blinding, an additional active transducer will be applied to a distant site, delivering perceptible vibration. Participants will be informed that the device acts through a systemic reflex stimulation mechanism. Device-related noise and tatactile stimulation on the contralateral limb will function as a sensory distractor.",[9,16],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":26},"Università degli studi di Foggia","Foggia","FG","71121","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],15.55188,41.45845,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Spina Stefania","md phd pmr Specialist","100632443","focal-vibration-therapy-in-post-stroke-shoulder-pain-100632443",false,"NCT07513753","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","VIBRA-HSP","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ischemic or hemorrhagic stroke confirmed by CT or MRI\n* Chronic post-stroke phase (≥ 6 months from event)\n* Presence of hemiplegic shoulder pain (NRS ≥ 4)\n* Preserved cognitive function sufficient to provide informed consent\n\nExclusion Criteria:\n\n* 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).\n* Severe neglect, apraxia, or disorders of consciousness that interfere with participation in rehabilitation or outcome assessments.\n* 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).\n* Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment.\n* Botulinum toxin injections to shoulder upper limb muscles within the last 3-4 months prior to enrollment .\n* Current treatment with other experimental or non-conventional physical therapies for shoulder pain during the study period.","ALL","18 Years","80 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"NA","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.\n\nFocal 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.\n\nThis 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.",[68,69,70],"Stroke","Hemiplegic Shoulder Pain","Chronic Stroke Survivors",[72,73,74,69],"Focal vibration Therapy","stroke","pain","NOT_YET_RECRUITING","2026-03-30",{"date":78,"type":79},"2026-04-07","ACTUAL",{"date":81,"type":62},"2026-04-01",{"date":83,"type":62},"2026-12-01",{"name":5,"class":6},1]