Focal Microvibration and Chronic Lumbosacral Radicular Pain

Federico II University

Status

Not yet enrolling

Conditions

Pain, Chronic

Radicular; Neuropathic

Lumbosacral Radiculopathy

Treatments

Device: Equistasi®

Drug: Gabapentin; Pregabalin; Duloxetine; Amitriptyline

Device: Sham

Study type

Interventional

Funder types

Other

Identifiers

NCT06301061

PB001

Details and patient eligibility

About

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.

Full 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)

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 3 patient groups

Patients treated with Focal Microvibration

Experimental group

Description:

Patients will be treated with focal microvibration through the application on the skin of four devices for 6 hours/day every day except thursady and Sunday.

Treatment:

Device: Equistasi®

Patients treated with a Sham device

Sham Comparator group

Description:

Patients will be treated with four sham device which will be attached on the skin for 6 hours/day every day except thursady and Sunday.

Treatment:

Device: Sham

Patients treated with standard pharmacological approach

Active Comparator group

Description:

Patients will be treated with standard pharmacological therapy