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临床试验/NCT07468799
NCT07468799已完成不适用

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

Hasanuddin University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Pain intensity score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

rTMS Treatment

Experimental

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.

干预措施: Repetitive Transcranial Magnetic Stimulation (Device)

结局指标

主要结局

Pain intensity score

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hasanuddin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jumraini Tammasse

Neurologist

Hasanuddin University

研究点 (1)

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