Neuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome

Summary

The aim of this clinical trial is to see if transcranial electrical stimulation (tES) can help reduce pain and improve quality of life in children and adolescents (ages 10-21, both sexes) with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The main questions are whether active tES works better than sham (placebo) stimulation for pain relief and whether it leads to measurable changes in brain activity.Participants will be randomly assigned to receive either active or sham tES for 20 minutes a day over two weeks. They'll complete questionnaires about their pain and quality of life, do some simple physical and motor tests, and undergo non-invasive brain measurements before and after the intervention. The results will help understand if tES is a safe and effective option for managing chronic pain in young people.

Specific Aims:

Aim 1a. transcranial stimulation will be associated with significant improvements in pain and functioning (e.g., 30% or greater symptom relief or 20% or greater improvement in QoL) Aim 1b. For each tES condition, estimate mean changes in motor evoked potential (MEP) amplitudes induced by TMS stimulation.

Aim 2. Compare the tES conditions (Active, Sham) in terms of the mean changes in MEP amplitude.

Aim 3. Obtain statistical estimates of variance components needed for the planning of a future study. Therefore, we hypothesize that anodal tES stimulation decreases MEP amplitudes compared to sham tES condition. We further hypothesize that MEP amplitudes are positively correlated. This study will be the first randomized, double-blind, controlled study of tES technology in children as an adjunctive pain management strategy for MPS.

Data from this trial will likely yield information regarding the feasibility and efficacy of tES as a chronic pain-management approach.

Conditions

• Pain Syndrome
• Fibromyalgia
• CRPS (Complex Regional Pain Syndromes)
• Neuromodulation
• Juvenile
• Physical Disability
• Physical Inactivity

Interventions

OTHER

Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)

Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique used in this study to investigate its effects on central pain processing in pediatric patients with juvenile fibromyalgia and other non-inflammatory musculoskeletal pain syndromes. The intervention is integrated within a multidisciplinary approach that combines behavioral assessments, neurophysiological measurements, and quality of life evaluations. The study aims to assess the impact of tES on pain reduction, functional improvement, and neurophysiological markers, while ensuring safety and tolerability in a young population. The intervention is delivered using CE-certified equipment and follows international safety guidelines

Sponsors & Collaborators

• Istituto Giannina Gaslini

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

10 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2027-03-31

Completion

2028-03-31

Countries

• Italy

Study Locations