Focal Microvibration and Chronic Lumbosacral Radicular Pain

March 3, 2024 updated by: Maria Vargas, Federico II University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Sham Comparator: 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.
Device: Sham
Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients
Other Names:
  • No active device
Active Comparator: Patients treated with standard pharmacological approach
Patients will be treated with standard pharmacological therapy
Drug: Gabapentin; Pregabalin; Duloxetine; Amitriptyline
Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.
Other Names:
  • Drugs for neuropathic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 12 months
Change in pain intensity with numeric rating scale (NRS): NRS ranges from 0 (no pain) to 10 (the the worst pain imaginable)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain interference in daily life
Time Frame: 12 months
Pain interference in patient daily life: mood, general activity, social relationship, work ability measured by Brief Pain Inventory (BPI). BPI is a 9 item self-administered questionnaire and every item score ranges from 0 to 10: a higher score indicates a worst outcome.
12 months
Disability
Time Frame: 12 months
Disability related to pain severity measured by and Oswestry Disability Index (ODI). ODI score ranges from 0 to 100; a higher score on the ODI indicates a more severe disability caused by low back pain.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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