Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-28 @ 2:34 PM
Study NCT ID:
NCT06301061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal Microvibration and Chronic Lumbosacral Radicular Pain
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
Effectiveness of Focal Microvibration in the Management of Chronic Lumbosacral Radicular Pain: a Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: