Study of the Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Analog Visual Scale
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a non-invasive therapy increasingly used in facilities treating patients with chronic pain. This complementary therapy has the advantage of being non-pharmacological, with transient and mild side effects, an excellent safety profile, and good efficacy in the contexts where it has been the subject of dedicated research: neuropathic pain, fibromyalgia, and visceral pain. Few studies have focused on the application of tDCS in the context of complex regional pain syndrome (CRPS), which is a common condition.
详细描述
This protocol aims to compare a group receiving a tDCS protocol with a sham control group. The hypothesis of this study is that tDCS is effective in treating CRPS in terms of reducing pain and the functional and emotional consequences of pain.
The primary objective of the study is to evaluate the effectiveness of tDCS on pain in patients with CRPS (complex regional pain syndrome), measured by the numerical pain scale (EN), after one month of treatment and one month after the end of treatment, compared to the sham arm.
The secondary objectives are:
- To assess anxiety and depression symptoms (HAD)
- To assess the functional impact of pain (Concise Pain Questionnaire - QCD)
- To assess central sensitization (Central Sensitization Inventory - CSI)
- To identify adverse effects related to tDCS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically active or active complex regional pain syndrome (CRPS) with positive Budapest criteria
- •Scintigraphy showing signs consistent with CRPS
- •Being affiliated with or a beneficiary of a social security scheme
排除标准
- •Algodystrophy no longer meeting the Budapest criteria
- •Relative contraindication to tDCS: psychosis (including treated psychosis), uncontrolled epilepsy, large scalp scar, intracerebral/intracranial metallic body
- •Pregnant or breastfeeding women
- •Persons under legal protection (guardianship, conservatorship, and protective supervision)
- •Persons deprived of their liberty by judicial or administrative order
- •Unwilling individuals who cannot give their consent or cannot return for scheduled visits according to the protocol
研究组 & 干预措施
Patient group receiving tDCS stimulation
Progressive increase in stimulation intensity up to 2 mA, then continuation at a plateau for a total of 20 minutes, then a decrease in stimulation intensity for 30 seconds at the end of the session before an automatic stop.
干预措施: transcranial direct current stimulation (Other)
Patient group receiving tDCS placebo stimulation
Control group : The stimulation intensity is gradually increased up to 2 mA for 1 minute, then decreased to zero stimulation. A further increase in stimulation is programmed 10 minutes after the start of stimulation.
干预措施: Placebo (Other)
结局指标
主要结局
Analog Visual Scale
时间窗: one month post treatment
次要结局
未报告次要终点