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OpenTrials
Completed

NCT Number: NCT07468799

High-Frequency rTMS Over the DLPFC for Chronic Low Back Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Acronym: RTMS-CLBP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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