NCT06301061

Focal Microvibration and Chronic Lumbosacral Radicular Pain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is the first randomized controlled study aiming to assess the potential use of focal microvibration for the management of chronic lumbosacral radicular pain which is the pain consequent to the compression of a spinal nerve root. Focal microvibration has been so far used to treat gait disorders and instability consequent to diseases such as Parkinson's disease, stroke, ataxia, multiple sclerosis with impressive results and no reported side effects. Our trial involves three arms: one arm treated with a device able to deliver focal microvibration, one arm treated with a sham device, and one arm treated with standard pharmacological therapy according to international guidelines. Patients with the active and with sham devices will attach them on their skin for 6 hours/day except on Thursday and Sunday: this application schedule with two days of treatment suspension has intended to avoid habituation to the sub-perception microvibration stimulation. The follow up will be 12 months and periodic visits will be performed after 7, 15 30, 45, 60, 90, 180, and 360 days of treatment. All the patients enrolled in the study will have access to rescue analgesic drugs such as paracetamol 1g and tramadol 100mg in case on excessive pain. Randomization will be performed by a computer-generated sequence. During the follow up visits, patients will be asked to fill questionnaires to explore and monitor pain intensity and pain interference in daily life: brief pain inventory (BPI) and Oswestry disability index (ODI)

Conditions

• Pain, Chronic
• Lumbosacral Radiculopathy
• Radicular; Neuropathic

Interventions

Type	Name	Description
DEVICE	Equistasi®	Four devices will be attached to the skin according the indication of the investigators for 6 hours/day every day except Thursday and Sunday
DEVICE	Sham	Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients
DRUG	Gabapentin; Pregabalin; Duloxetine; Amitriptyline	Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2024-03-08
• Last updated: 2024-03-08