Focal Vibration Therapy in Post-stroke Shoulder Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

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. 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: 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. 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.

Study summary

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

Primary outcome measure(s)

• Change in Pain Intensity Assessed by Numerical Rating Scale (NRS) — From baseline (Day 0) to the Day 15 (end of treatment)
  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.

Trial sites (1)

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