High-Frequency rTMS Over the DLPFC for Chronic Low Back Pain (RTMS-CLBP)

March 9, 2026 updated by: Jumraini Tammasse, Hasanuddin University

High-Frequency Repetitive Transcranial Magnetic Stimulation Over the Dorsolateral Prefrontal Cortex Enhances IL-10 and Reduces Pain in Chronic Low Back Pain: A Randomized Controlled Trial

Neuropathic pain is a chronic condition that significantly affects quality of life and often responds poorly to conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a non-invasive neuromodulation technique with potential analgesic effects.

This study aimed to evaluate the effectiveness of rTMS in reducing neuropathic pain intensity among patients with confirmed neuropathic pain. A clinical study was conducted involving adult patients who met diagnostic criteria for neuropathic pain. Participants received rTMS sessions targeting the motor cortex over a defined treatment period.

Pain intensity was assessed using standardized pain scales before and after treatment. The study examined changes in pain scores following rTMS therapy and evaluated its potential as an adjunctive treatment for neuropathic pain.

The findings of this study may contribute to understanding the therapeutic role of rTMS in the management of neuropathic pain and support its use as a non-invasive treatment option.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neuropathic pain is caused by lesions or diseases affecting the somatosensory nervous system and is often difficult to manage with conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that modulates cortical excitability and has been investigated as a potential treatment for neuropathic pain.

This study was conducted to evaluate the effectiveness of rTMS therapy in patients diagnosed with neuropathic pain. Eligible patients who met the diagnostic criteria for neuropathic pain were enrolled and received rTMS stimulation targeting the primary motor cortex (M1). The stimulation protocol followed standard clinical parameters used for pain modulation.

Participants underwent multiple rTMS sessions during the treatment period. Pain intensity was evaluated using validated pain assessment scales before treatment and after completion of the rTMS sessions. The primary objective was to determine whether rTMS therapy could significantly reduce pain intensity in patients with neuropathic pain.

Secondary observations included the tolerability of the intervention and clinical responses among participants following the stimulation protocol. Data were analyzed to compare pain scores before and after treatment.

The study was conducted in accordance with ethical standards and approved by the institutional ethics committee. The results aim to provide evidence regarding the role of rTMS as a therapeutic option for neuropathic pain management.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Hasanuddin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • Diagnosed with schizophrenia according to DSM-5 criteria
  • Experiencing neuropathic pain or chronic pain symptoms
  • Stable psychiatric medication for at least 4 weeks prior to enrollment
  • Able to provide written informed consent

Exclusion Criteria:

  • History of epilepsy or seizure disorders
  • Presence of metallic implants in the head
  • Severe neurological disorders
  • Substance abuse within the past 6 months
  • Pregnancy or breastfeeding
  • Contraindications to rTMS therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS Treatment
Participants receive repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex as a therapeutic intervention for neuropathic pain. Clinical outcomes including pain severity and inflammatory biomarkers are assessed before and after the intervention.
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) delivered over the primary motor cortex using a magnetic coil to generate repeated magnetic pulses. The stimulation sessions are administered to modulate cortical excitability and reduce neuropathic pain symptoms. Participants receive multiple treatment sessions according to the study protocol, and clinical outcomes are evaluated before and after the intervention.
Other Names:
  • rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity score
Time Frame: Baseline and immediately after completion of the rTMS treatment sessions
Change in neuropathic pain intensity measured using the Visual Analog Scale (VAS). Pain scores are assessed before the rTMS intervention and after completion of the treatment sessions.
Baseline and immediately after completion of the rTMS treatment sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNHAS-RTMS-CLBP-2024
  • 012/UNHAS/LPPM/2025 (Other Grant/Funding Number: LPPM UNHAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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