Effects of tDCS and Physical Therapy on Pain in Women With Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Analogic Scale
研究概览
简要总结
The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model.
详细描述
A factorial, randomized clinical trial will be conducted to evaluate pain control, the number of migraine attacks, quality of life, emotional dysfunctions, and attentional processing of migraine patients.
Clinical outcomes will be evaluated through (I) a Visual Analog Scale (VAS); (II) pressure pain threshold; (III) a Headache Impact Test (HIT-6); (IV) a Migraine Disability Assessment (MIDAS); (V) Short-Form Health Survey Questionnaire de 36 items (SF-36); (VI) Patients' Global Impression of Change Scale (PGICS); (VII) Beck Depression Inventory (BDI); (VIII) State-Trait Anxiety Inventory (S-TAI); (IX) Perceived Stress Scale (PSS); and (X) Facial Expression Database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-50 years old;
- •with Chronic Migraine according to ICHD-3 beta;
- •literate;
- •stable on routine medications specific for MC for at least 2 months, who were not undergoing other types of non-pharmacological interventions for MC, not lactating or pregnant, without neurological diseases or serious neuropsychiatric diseases, without other types of associated headaches, without signs and/or symptoms of spinal radiculopathy, without metal implants located in the head and/or cochlear implants.
排除标准
- •who perhaps become pregnant during the execution of the clinical trial
- •present some disease that disables their continuity in the treatment
- •start another type of treatment
- •show changes in physical activity and/or eating routine during the research
- •has severe depression (BDI > 35).
结局指标
主要结局
Visual Analogic Scale
时间窗: baseline, one month, two month
This scale will be used to measure the patients' pain intensity. The scale consists of a 100 mm line within the limits of no pain and worst possible pain. The patient is instructed to trace the intensity of his pain within the limits of the line. Changes of 1.1 to 1.2 cm indicate minimal clinical improvement.
pressure pain threshold
时间窗: baseline, one month, two month
We analyzed the following points with the pressure algometer: anterior and posterior fibers of the temporal muscle, frontal region, insertion of the sternocleidomastoid muscle, insertion and middle fibers of the upper trapezius muscle, thenar region of the right upper limb.
次要结局
- Headache Impact Test(baseline, one month, two month)
- Migraine Disability Assessment(baseline, one month, two month)
- Short-Form Health Survey Questionnaire(baseline, one month, two month)
- Patients' Global Impression of Change Scale(baseline, one month, two month)
- Beck Depression Inventory(baseline, one month, two month)
- State-Trait Anxiety Inventory(baseline, one month, two month)
- Perceived Stress Scale(baseline, one month, two month)
- Facial Expression Database(baseline, one month, two month)
研究者
Renata Emanuela Lyra de Brito Aranha
principal investigator, master's degree in cognitive and behavioral neuroscience
Federal University of Paraíba