Effectiveness of Focal Microvibration in the Management of Chronic Lumbosacral Radicular Pain: a Randomized Controlled Study

PB001

The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\[s\] it aims to answer are: * Can focal microvibration improve pain in this patient population? * Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday. Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.

2024-04-01

2025-10-01

2026-04-01

Not yet recruiting

150

Inclusion Criteria: * Pain duration≥6 months * Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots * Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots * Monolateral pain * Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4. Exclusion Criteria: * Psychiatric patients * Cancer patients * Patients affected by disease characterized by spasticity or muscular stiffness: Parkinson's disease, multiple sclerosis, stroke, spine injuries. * Patients with spinal or dorsal root ganglion stimulators * Patients undergone central of peripheral stimulation in the past 3 months * Patients affected by fibromyalgia. * Patients undergone central nervous system surgery * Patients with reduced renal function eGFR≤60ml/min/1,73m2

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-03-08