Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- pain intensity by VAS
研究概览
简要总结
This project protocol investigates the efficacy of transcranial direct current stimulation (tDCS) in treating neuropathic pain and improving sleep quality among Brazilian military personnel. Given the high prevalence of chronic pain and sleep disturbances in this population, and the limitations of current pharmacological treatments, our randomized, triple-blinded, sham-controlled trial explores the potential of tDCS as a non-invasive therapeutic intervention. The results of this study could have a significant impact on improving the well-being and performance of military personnel, while also reducing healthcare costs associated with long-term medication use.
详细描述
The intervention will be carried out into two-weeks daily consecutive sessions of 20 minutes each, with 1 session per day, and a weekend interval. Direct current stimulation will be administered through an electrical stimulator model MicroEstim Genius (NKL), Brusque, Brazil. During the session, the participants will be awake and seated in a comfortable seat. The environment will be air-conditioned, free of visual and auditory stimuli.
The sessions will be conducted by a trained health professional. The groups will receive single-phase direct current with an intensity of 2 mA up, according to data presented by Pacheco-Barrios et al. (2021). Electrodes with a size of 35cm² (5 x 7 centimeters) will be used. Electrodes will be placed on the scalp, fixed with elastic bands, and immersed in 10 to 12 mL of saline solution.
The electrode montage will be performed for one of two possible targets: anodal stimulation over DLPFC or anodal stimulation over M1, and also sham in both targets according to the participants' designations after randomization to one of the three groups.
The device displays will be identical across active and sham groups, and to ensure blinding, an active current will be applied for 30 seconds at the beginning and end of the sham stimulation to mimic the sensation of the current ramp experienced in active stimulation. Stimulations of less than 3 minutes of tDCS do not induce cortical excitability effects, according to Nitsche and Paulus (2000), being safely inactive for the expected results.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A triple-blinding strategy will be implemented, including participants and outcome assessors, as well as staff responsible for recruitment and statistical analysis. To ensure proper intervention, only the health professional administering the treatment will know each participant's assigned group.
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
- •Military personnel (active and veterans) with chronic pain due to central or peripheral neuropathy and poor sleep quality;
- •Age over 18 years old;
- •Defined chronic NeP according to current guidelines (ICD-10 codes OR DN-4);
- •Pain with an average intensity score above 40/100 mm on a visual analogue scale (VAS);
- •Medication stability (chronic pain, depression, anxiety, sleep) for at least six weeks;
- •Patients with bad sleep quality identified by the Pittsburgh Sleep Quality Index (PSQI) of 5 or more who do not improve under conventional treatment.
排除标准
- •General contraindications for tDCS: past head trauma, current epilepsy, intracranial ferromagnetic components, pacemaker, implanted microprocessors (i.e., cochlear implants);
- •Pregnancy;
- •Known major psychiatric disorders (as assessed by the DSM-5, e.g., psychosis), history of substance abuse, or work litigation issues;
- •History of chronic refractory migraines;
- •Non-treated moderate to severe sleep apnea defined as apnea/hypopnea index greater than 15 events per hour in baseline polysomnography;
- •Skin conditions such as psoriasis or eczema that involve the scalp (Thair et al, 2017);
- •Cancer-related pain;
- •BMI >35, due to increased reports of pain associated with increased BMI (Basem, et al., 2021; Stokes et al., 2020);
- •Patients who do not sign informed consent or do not want to participate in the study.
结局指标
主要结局
pain intensity by VAS
时间窗: at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.
The primary outcome is a reduction in pain intensity by at least 30% (Dworkim et al., 2004; Farrar et al 2001). It will be assessed using the 100 mm Visual Analogue Scale (VAS), which consists of straight lines 100 mm long indicating "no pain" on one end and "worst possible pain or most intense pain possible" on the other (Huskisson, 1974). The VAS is scored by measuring the distance from the "no pain" end of the line. Pain intensity will be assessed daily during the 10day intervention.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(It will be measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.)
- Epworth Sleepiness Scale (ESS)(at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.)
- the Visual Analogue Scale for Fatigue Severity (VAS-F)(measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.)
- Polysomnographic evaluation - time(PSG will be measured at baseline and at the end of the ten-day treatment.)
- Polysomnographic evaluation - arousal index(PSG will be measured at baseline and at the end of the ten-day treatment.)
- Polysomnographic evaluation - sleep efficiency(PSG will be measured at baseline, at the end of the ten-day treatment.)
- Polysomnographic evaluation- sleep stages(at baseline, at the end of the ten-day treatment.)
- Polysomnographic evaluation- PLMI(PSG will be measured at baseline, at the end of the ten-day treatment.)
研究者
Eline Rozária Ferreira Barbosa
Principal Investigator
Hospital da Polícia Militar de Goiás