Pain SyndromeNMJFP protocolNCT07785362
Neuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome
A study testing Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP) in people with Pain Syndrome and Fibromyalgia, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pain Syndrome, Fibromyalgia, CRPS (Complex Regional Pain Syndromes)
- What is being tested?
- Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects aged between 10 and 21 years.Patients with fibromyalgia according to the 1990 criteria of the American College of Rheumatology or Patients with other types of non-inflammatory musculoskeletal pain syndromes.Patients who reported a mean pain score > 4 on a 10-point visual analog scale (VAS) during the two weeks preceding the clinical trial.Disease duration for more than 6 months, no change in drug treatments during the last month, and lack of response to conventional treatments.
- Exclusion Criteria: iagnosis of epilepsy or at risk of seizuresPresence of a cardiac pacemakerPresence of an implanted infusion pump, metal plates in the skull, or metal objects in the eye and skull (e.g., after neurosurgical interventions)Past or present history of substance abusePast or present history of neuropsychiatric disorders (major depression and schizophrenia)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
Read the detailed description
This clinical trial investigates the efficacy and safety of transcranial electrical stimulation (tES) as a non-pharmacological intervention for pain management in pediatric patients (ages 10-21, both sexes) with juvenile fibromyalgia (JFM) and other non-inflammatory musculoskeletal pain syndromes (MPS). These conditions are characterized by chronic, widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive and psychological symptoms, and significantly reduced quality of life. Current management strategies are multidisciplinary, but there is no gold standard treatment, especially for pediatric patients.The study is a 24-month, open-label, randomized, actively controlled, mono-center, prospective, superiority trial. Forty-six participants will be randomly assigned to one of two arms: Active tES or Sham tES. The primary aim is to determine whether active tES leads to significant improvements in pain (≥30% reduction) and quality of life (≥20% improvement) compared to sham stimulation. Secondary aims include evaluating changes in neurophysiological markers (such as motor evoked potentials, MEPs) and functional outcomes.Participants will undergo a comprehensive assessment including behavioral, neurophysiological, and patient-reported outcome measures. Behavioral assessments include quality of life questionnaires (J-FiMAR), physical and motor function tests (6-Minute Walking Test, Shuttle Run, Sit-up, Long Jump, Flamingo Balance Test, Functional Mobility Scale), and patient-reported outcomes (pain, fatigue, sleep, mood). Neurophysiological assessments involve transcranial magnetic stimulation (TMS) and electromyography (EMG) to measure cortical excitability and MEPs before and after the intervention.The intervention consists of 10 consecutive daily sessions (over 2 weeks) of either active or sham tES. Active tES is delivered for 20 minutes per session, with the anodal electrode placed over the left primary motor cortex (C3, 10-20 EEG system) and the reference electrode over the contralateral supraorbital region. Sham tES mimics the initial sensation of stimulation but does not deliver active current after the first minute. Both protocols use CE-certified, pediatric-appropriate equipment and follow international safety guidelines.Randomization is performed using random permuted blocks via Random.org to ensure balanced group allocation. The study includes interim analysis after 50% enrollment. Data analysis will use appropriate statistical methods (t-tests, ANOVA, non-parametric tests, Bonferroni correction) to compare outcomes between groups and assess effect sizes.Risks associated with tES and TMS are minimal, with the most common adverse effects being mild and transient (e.g., headache, tingling). Strict inclusion/exclusion criteria and continuous monitoring ensure participant safety. Ethical conduct is maintained according to international guidelines, with informed consent/assent required from all participants and their guardians.The results of this trial will provide valuable evidence on the feasibility, safety, and effectiveness of tES as a pain management strategy in young people with JFM and related conditions. The study also aims to identify objective neurophysiological and functional markers that could guide future personalized interventions and improve quality of life for affected patients.
- Conditions
- Pain Syndrome, Fibromyalgia, CRPS (Complex Regional Pain Syndromes), Neuromodulation, Juvenile, Physical Disability
- Being tested
- Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)
- Keywords
- Pain syndrome, Fibromyalgia, Complex regional Pain Syndrome, Neuromodulation, Juvenile, Physical Disability, Physical Inactivity
- Medical subject headings
- Somatoform Disorders, Fibromyalgia, Complex Regional Pain Syndromes, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Active tES | Active comparator | Active tES (transcranial electrical stimulation) is a non-invasive brain stimulation technique that involves applying a low-intensity electrical current (up to 2 mA) to specific areas of the cerebral cortex through electrodes placed on the scalp. In this study, the active tES protocol delivers current for 20 minutes per session, over 10 consecutive days (2 weeks), with the anodal electrode placed over the left primary motor cortex (C3 position, according to the 10-20 EEG system) and the reference electrode over the contralateral supraorbital region. The goal is to modulate cortical excitability and reduce pain in patients with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The procedure is safe, well-tolerated, and monitored for adverse effects Receives: Other: Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP) |
| Sham tES | Sham comparator | Sham tES (transcranial electrical stimulation) is a placebo-controlled procedure designed to mimic the experience of active tES without delivering a sustained electrical current. In this study, for the sham protocol, electrodes are placed in the same positions as for active stimulation. After an initial ramp-up period of 30 seconds, the stimulation fades out over the next 30 seconds, so participants feel the initial tingling sensation but receive no active current for the remainder of the session. At the end of the sham session, stimulation fades in again for 30 seconds and then ends with a final 30-second ramp-down. This method reliably simulates the sensations of active tES and helps reduce expectation bias, while ensuring that no actual neuromodulatory effect is delivered Receives: Other: Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity from Baseline to Post-Intervention in Pediatric Patients with Non-Inflammatory Musculoskeletal Pain Syndromes Treated with Non Invasive Brain Stimulation (NIBS)
The primary purpose of this study is to evaluate whether non-invasive brain stimulation (NIBS), specifically transcranial electrical stimulation (tES), can significantly reduce pain in children and adolescents with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The intervention aims to modulate brain circuits involved in pain perception using safe, non-pharmacological techniques. Changes in pain (30% or greater symptom relief, misured by Visual analogue scale - 0= worse/10= better) will be measured before and after treatment, comparing active and sham stimulation groups.
Measured: Primary outcomes will be assessed at four time points: before the first tES session (baseline), immediately after the last session (post-intervention, after 2 weeks), and at 1 month and 3 months after
Change in Health-Related Quality of Life from Baseline to Post-Intervention in Pediatric Patients with Non-Inflammatory Musculoskeletal Pain Syndromes Treated with Non Invasive Brain Stimulation (NIBS)
The primary purpose of this study is to evaluate whether non-invasive brain stimulation (NIBS), specifically transcranial electrical stimulation (tES), can significantly reduce pain in children and adolescents with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The intervention aims to modulate brain circuits involved in pain perception using safe, non-pharmacological techniques. Changes in QoL quality of life (20% or greater improvement in QoL, misured by Visual analogue scale - 0= worse/10= better) will be measured before and after treatment, comparing active and sham stimulation groups.
Measured: Primary outcomes will be assessed at four time points: before the first tES session (baseline), immediately after the last session (post-intervention, after 2 weeks), and at 1 month and 3 months after
Secondary outcomes (2)
Change in multidimensional patient-reported outcomes from baseline to follow-up.
The secondary outcome measures in this study are designed to provide a comprehensive evaluation of the impact of transcranial electrical stimulation (tES) on multiple aspects of functioning and well-being in children and adolescents with juvenile fibromyalgia and other non-inflammatory musculoskeletal pain syndromes patient-reported outcomes including fatigue, sleep quality, mood, and cognitive function, as well as physical activity and sedentary behavior patterns.
Measured: Secondary outcomes will be assessed at four time points: before the first tES session (baseline), immediately after the last session (post-intervention, after 2 weeks), and at 1 month and 3 months after
Change in functional and motor performance from baseline to follow-up.
The secondary outcome measures in this study are designed to provide a comprehensive evaluation of the impact of transcranial electrical stimulation (tES) on multiple aspects of functioning and well-being in children and adolescents with juvenile fibromyalgia and other non-inflammatory musculoskeletal pain syndromes in functional and motor performance through standardized tests (6-Minute Walking Test= meters; Shuttle Run= Seconds; Sit-up= number, Long Jump= meters, Flamingo Balance= number, FMS= meters).
Measured: Secondary outcomes will be assessed at four time points: before the first tES session (baseline), immediately after the last session (post-intervention, after 2 weeks), and at 1 month and 3 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start31 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 24-month, open-label, randomized, actively controlled, mono-center, prospective, superiority clinical trial.Randomized: Participants are assigned randomly to treatment groups.Controlled: There is a control (sham) group receiving placebo stimulation.Prospective: Data are collected forward in time from enrollment.Superiority: The study aims to show that active stimulation is superior to placebo.Mono-center: Conducted at a single center (IRCCS G. Gaslini).Open-label: Both researchers and participants know the assigned treatment.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785362
- Sponsor's protocol ID
- IRCCS Istituto Giannina Gaslin
- Acronym
- NMJFP protocol
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No