MedTrace Logo

Focal Microvibration and Chronic Lumbosacral Radicular Pain

NCT06301061 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Pain, Chronic
  • Lumbosacral Radiculopathy
  • Radicular; Neuropathic

Interventions

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.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-10-01
Completion
2026-04-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301061 on ClinicalTrials.gov