Accelerated protocol of Non-Invasibe Neuromodulation for Pain control

Accelerated protocol of Repetitive Transcranial Magnetic Stimulation for Chronic Musculoskeletal Pain control

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-4mzhbd3

Enrollment

Unknown

Registered

2024-09-19

Start date

2023-01-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Pain

Interventions

This phase 1 clinical trial is randomized, double-blind, and has a two-stage crossover design. It includes 25 adults with chronic musculoskeletal pain, diagnosed for over three months, and pain intens

E02.621.820

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult individuals aged 18 or over; both genders; with musculoskeletal-origin Chronic Pain, diagnosed by a specialist physician for at least three months, and with a pain intensity greater than 4/10 on the Visual Analog Pain Scale (VAS)

Exclusion criteria

Exclusion criteria: Participants with diagnosis of fibromyalgia and migraine; more than 20% of electroencephalogram (EEG) channels requiring rejection due to artifacts; change in their pharmacological or non-pharmacological treatment regimen during the study

Design outcomes

Primary

Measure	Time frame
Assessment of pain intensity using the Numerical Rating Scale (NRS), a reduction of at least two points on the scale is expected after active treatment	—

Secondary

Measure	Time frame
The assessment of the distribution, intensity, and impact of pain will be conducted using a Brief Pain Inventory (BPI) before and after the interventions;The quality of pain will be assessed using the short form of the McGill Pain Questionnaire (SF-McGill) before and after the interventions;The type of pain, classified as nociceptive, neuropathic, or mixed, will be assessed using the Brazilian versions of the neuropathic pain questionnaires DN4;The assessment of central sensitization will be conducted using the Central Sensitization Inventory (CSI) to categorize the sample into individuals with or without central sensitization before the interventions;Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) to categorize the sample into individuals with or without possible anxiety and depression before the interventions;To assess patient satisfaction or their perception of improvement after treatment, the Brazilian version of the Patient Global Impression of Change (PGIC) scale will be used ;The safety of the treatment will be assessed after the interventions using a structured questionnaire developed by the authors to evaluate adverse effects;Intracerebral electrical sources will be evaluated using standardized low-resolution brain electromagnetic tomography (sLORETA) before and after each intervention.;o quantify the phase asymmetry between two signals and functional connectivity before and after each intervention, brain connectivity will be measured using the Phase Lag Index;he efficiency and clustering coefficient of brain connectivity, measured using the Small-World Parameter (SWP), will be evaluated before and after each intervention;The pressure pain threshold will be assessed using a pressure algometer before, during, and immediately after the interventions	—

Measure

Time frame

The assessment of the distribution, intensity, and impact of pain will be conducted using a Brief Pain Inventory (BPI) before and after the interventions;The quality of pain will be assessed using the short form of the McGill Pain Questionnaire (SF-McGill) before and after the interventions;The type of pain, classified as nociceptive, neuropathic, or mixed, will be assessed using the Brazilian versions of the neuropathic pain questionnaires DN4;The assessment of central sensitization will be conducted using the Central Sensitization Inventory (CSI) to categorize the sample into individuals with or without central sensitization before the interventions;Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) to categorize the sample into individuals with or without possible anxiety and depression before the interventions;To assess patient satisfaction or their perception of improvement after treatment, the Brazilian version of the Patient Global Impression of Change (PGIC) scale will be used ;The safety of the treatment will be assessed after the interventions using a structured questionnaire developed by the authors to evaluate adverse effects;Intracerebral electrical sources will be evaluated using standardized low-resolution brain electromagnetic tomography (sLORETA) before and after each intervention.;o quantify the phase asymmetry between two signals and functional connectivity before and after each intervention, brain connectivity will be measured using the Phase Lag Index;he efficiency and clustering coefficient of brain connectivity, measured using the Small-World Parameter (SWP), will be evaluated before and after each intervention;The pressure pain threshold will be assessed using a pressure algometer before, during, and immediately after the interventions

—

Countries

Brazil

Contacts

Public ContactAbrahão Baptista

Fundação Universidade Federal do ABC

a.baptista@ufabc.edu.br+55 24 98882-2040

Outcome results

None listed

Source: REBEC (via WHO ICTRP)