UnknownNot Applicable

Focal Microvibration and Chronic Lumbosacral Radicular Pain

150 participantsStarted 2024-04-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain intensity

Timeframe: 12 months

Trial details

NCT IDNCT06301061

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Pain, Chronic trials