Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06301061 |
Other study ID # |
PB001 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2024 |
Est. completion date |
April 1, 2026 |
Study information
Verified date |
March 2024 |
Source |
Federico II University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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)