Does Transcranial Direct Current Stimulation (tDCS) Improve the Effect of Mirror Therapy? A Double-blind Randomized Controlled Study in Patients With Phantom Limb Pain.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The Visual Analog Scale (VAS)
研究概览
简要总结
In this study we will examine assess if treatment with transcranial Direct Current Stimulation (tDCS) improve the analgesic effects of mirror therapy for patients with phantom pain of lower extremity. The study will include 3 arms: only mirror therapy, mirror therapy + sham tDCS, and mirror therapy + active tDCS.
详细描述
Phantom pain following amputation is difficult to treat, resulting in many patients who suffer. One of the mechanisms suspected to contribute to phantom pain is abnormal plasticity and reorganization of the cortex.
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
It was hypothesize that combination of mirror therapy and tDCS treatment could result in additive effects. According to this hypothesis, the effects of the mirror therapy could be enhanced by the tDCS treatment. The aim of the current study is to investigate this hypothesis.
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
- •Age 18 or older
- •Underwent unilateral lower limb amputation in the past 3 months. A
- •Reported average phantom pain of 4 or more in the past week.
- •No change in other medications 1 week prior to enrollment, not including SOS.
- •Able understand the purpose of the study and to provide informed consent.
排除标准
- •Ferromagnetic metal in the head or neck.
- •Epilepsy or prior seizures within the last 1 year.
- •Suffering from severe depression
- •History of unexplained fainting or loss of consciousness
研究组 & 干预措施
Mirror therapy
Subjects will be asked to perform specific movements (using the unaffected limb while watching its mirrored reflection for 20 minutes per day, for 10 treatment days, completed during two weeks (every weekday, excluding weekends)
干预措施: Mirror therapy (Other)
Mirror therapy + sham tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, a sham tDCS treatment will be applied.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
Mirror therapy + sham tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, a sham tDCS treatment will be applied.
干预措施: Mirror therapy (Other)
Mirror therapy + active tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, an active tDCS treatment will be applied.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
Mirror therapy + active tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, an active tDCS treatment will be applied.
干预措施: Mirror therapy (Other)
结局指标
主要结局
The Visual Analog Scale (VAS)
时间窗: between baseline week and 4 weeks after the end of the treatment
The Visual Analog Scale (VAS) of the average Phantom Limb Pain in the past week will serve as primary measure. The primary outcome is the changes in the VAS score between baseline week and 4 weeks after the end of the treatment. VAS is a widely used, continuous measure of pain intensity, with scores ranging between 0-10, higher scores reflecting higher pain intensity.
次要结局
- McGill total score(between baseline week and 4 weeks after the end of the treatment)
- McGill sensory sub-score(between baseline week and 4 weeks after the end of the treatment)
- Changes in the worst pain(between baseline week and 12 weeks after the end of the treatment)
- Changes in the average pain(between baseline week and 12 weeks after the end of the treatment)
- Changes in the VAS score(between baseline week and 12 weeks after the end of the treatment)
- Changes in short-form McGill total score(between baseline week and 12 weeks after the end of the treatment)
- Changes in short-form McGill sensory sub-score(between baseline week and 12 weeks after the end of the treatment)
研究者
Hagay Amir
Medical Diractor
Loewenstein Hospital