Focal Microvibration and Chronic Lumbosacral Radicular Pain

NCT ID: NCT06301061

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients treated with Focal Microvibration

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.

Group Type: EXPERIMENTAL

Equistasi®

Intervention Type: DEVICE

Four devices will be attached to the skin according the indication of the investigators for 6 hours/day every day except Thursday and Sunday

Patients treated with a Sham device

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients

Patients treated with standard pharmacological approach

Patients will be treated with standard pharmacological therapy

Group Type: ACTIVE_COMPARATOR

Gabapentin; Pregabalin; Duloxetine; Amitriptyline

Intervention Type: DRUG

Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.

Interventions

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

Intervention Type: DEVICE

Sham

Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients

Intervention Type: DEVICE

Gabapentin; Pregabalin; Duloxetine; Amitriptyline

Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.

Intervention Type: DRUG

Other Intervention Names

No active device; Drugs for neuropathic pain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Maria Vargas

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Buonanno P, Iacovazzo C, Marra A, de Siena AU, Josu T, Zampi M, Sedda D, Servillo G, Vargas M. Potential Role of Focal Microvibration (Equistasi(R)) in the Management of Chronic Pain: A Pilot Study. Pain Ther. 2024 Feb;13(1):185-198. doi: 10.1007/s40122-023-00562-6. Epub 2023 Dec 6.

Reference Type: RESULT

PMID: 38057548 (View on PubMed)

Other Identifiers

PB001

Identifier Type: -

Identifier Source: org_study_id