Transcranial Direct Current Stimulation and Mirror Therapy in Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
Traumatic injuries of the brachial plexus cause sufficient weakness to affect the individual in its various aspects, limiting the execution of Activities of Daily Living, leading to highly disabling, and often definitive, clinical conditions with serious socioeconomic consequences. It causes motor, sensory and autonomic deficits, directly compromising the quality of life and functional performance of these individuals. It is a complex condition, whose recovery is usually slow and costly, in addition to often requiring surgery and rehabilitation. Among the therapeutic possibilities, the non-invasive neuromodulation techniques stand out, especially the Transcranial Direct Current Stimulation (ETCC) and the Mirror Therapy (ET). In this context, the present study aims to analyze the effectiveness of the ETCC technique combined with ET in the treatment of patients with pain due to trauma to the brachial plexus, investigating the degree of improvement in pain intensity, functionality, quality of life and mood of these patients, comparing the onset with immediately after applying the techniques.
详细描述
For this, a pilot clinical trial, placebo-controlled, blind and randomized, will be carried out, involving patients with traumatic brachial plexus injury, submitted to sessions of ETCC and mirror therapy. Participants will be randomly allocated to 1 of 2 groups: the first will receive active ETCC associated with TE and the second will receive simulated ETCC in conjunction with TE. The study will consist of 12 sessions, conducted over a period of 1 month, with 3 sessions weekly on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Assessments will be performed before the beginning of the protocol (baseline) and immediately after the end of the 12 sessions. The TCT-Research device, developed by Trans Cranial Technologies Ltda for ETCC and a rectangular platform with the dimensions of 40x70 cm, with a mirror sagittally coupled to the TE will be used. To assess the outcomes, EVA, McGill's Questionnaire, BPI, BDI, IDATE, SF-36 and CIF will be applied. For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, version 20.0, will be used and considered significant, an alpha value of 5% (p <0.05).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 over 18 years;
- •Score of 4 to 10 points on the Visual Analogue Scale;
- •Persistent pain and refractory to clinical treatment for at least 3 months;
- •Appropriate pharmacological treatment for pain for at least 1 month before the start of the study.
排除标准
- •Patients with other neurological diseases;
- •Past history of substance abuse;
- •Contraindications for ETCC.
研究组 & 干预措施
ETCC Active associated with Mirror Therapy (TE)
The study will consist of 12 sessions, being carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).
干预措施: TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY (Device)
ETCC simulated associated with Mirror Therapy (TE)
The study will consist of 12 sessions, being carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).
干预措施: TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY (Device)
结局指标
主要结局
Change in pain intensity
时间窗: Baseline and after 4 weeks
Visual analog scale (VAS) - One-dimensional instrument for assessing pain intensity. It is a line with the ends numbered 0-10. At one end line is marked "no pain" and on the other "worse pain imaginable".
Changes in pain interference in activities of daily living
时间窗: Baseline and after 4 weeks
1 - Brief Pain Inventory - reduced form (Brief Pain Inventory - BPI): Multidimensional instrument, which makes use of a scale of 0-10 to graduate the following items: intensity, pain interference on ability for walking, daily activities of the patient, at work, social activities, mood and sleep.
Change in pain characteristics
时间窗: Baseline and after 4 weeks
2 - McGill Pain Questionnaire - MPQ): The descriptors are divided into four groups: sensory discriminative, motivational affective, cognitive evaluative, and miscellaneous. The numerical index of descriptors is the number of words chosen by the patient to characterize your pain, being at most a word of each subgroup with a maximum value of 20. The pain index is calculated by adding the values of intensity of each descriptor (0-5), having this maximum 78.
次要结局
- Quality of life (SF-36)(Baseline and after 4 weeks)
- Anxiety(Baseline and after 4 weeks)
- Depression(Baseline and after 4 weeks)
- Functionality(Baseline and after 4 weeks)
研究者
Suellen Marinho Andrade
Principal Investigator and Professor
Federal University of Paraíba