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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Multimodal Focal Vibration Therapy (FVT)
DeviceParticipants 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. Physiokinesitherapy Phase (30 minutes): Participants will undergo a standardized rehabilitation protocol targeting recovery of the hemiplegic shoulder. Focal Vibration Therapy Phase (25 minutes): Four 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: * 5 minutes at 35 Hz for superficial analgesia * 10 minutes at 100 Hz for muscle tone reduction * 10 minutes at 200 Hz for deep analgesia
Standard Rehabilitation Program
Other interventionAll 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. Physiokinesitherapy Phase (30 minutes): Identical to that administered in the experimental group. Sham Procedure Phase (25 minutes): Four 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Focal Vibration Therapy + Standard RehabilitationExperimental treatment 2 interventions
Group B: Sham Focal Vibration Therapy + Standard RehabilitationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity Assessed by Numerical Rating Scale (NRS)
Change from baseline in pain intensity measured using the Numerical Rating Scale (NRS, 0-10) comparing multimodal Focal Vibration Therapy (FVT) plus standard rehabilitation versus standard rehabilitation plus sham procedure in patients with chronic post-stroke hemiplegic shoulder pain. Pain intensity will be assessed under three standardized conditions to reflect the multidimensional nature of hemiplegic shoulder pain: * Pain at rest (spontaneous pain) * Pain during passive range of motion (pROM) in shoulder flexion and abduction * Pain during active or active-assisted range of motion (aROM) The primary endpoint will be expressed as mean change (Δ score) between T0 and T1.
Time frame
From baseline (Day 0) to the Day 15 (end of treatment)Secondary outcomes
1
Change in Shoulder Function and Disability (SPADI)
Change from baseline in total score and subscale scores (Pain and Disability) of the Shoulder Pain and Disability Index (SPADI: range 0-100 where higher scores indicate greater pain and disability), comparing the two study groups across post-treatment and follow-up time points.
Time frame
Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up2
Change in Glenohumeral Range of Motion (ROM) (degrees)
Change from baseline in active and passive glenohumeral joint range of motion (ROM), including flexion, abduction, and external rotation, measured in degrees using a standardized universal goniometer. Higher values indicate improved joint mobility.
Time frame
Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up3
Change in Upper Limb Spasticity (Modified Ashworth Scale)
Change from baseline in muscle tone assessed by the Modified Ashworth Scale (MAS; range 0-4, where higher scores indicate greater spasticity) in shoulder internal rotators/adductors (Pectoralis Major, Subscapularis)
Time frame
Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up4
Change in Health-Related Quality of Life (SF-12)
Change from baseline in physical (PCS) and mental (MCS) health composite scores assessed using the Short Form-12 Health Survey (SF-12; higher scores indicate better health status).
Time frame
Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-upSponsors and contacts
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Source ClinicalTrials.gov
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