Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether electroacupuncture is effective in the treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue Scale and biomarkers.
详细描述
Tension-type headache can be defined as a constant sensation of pressure or heaviness, and is a highly-prevalent condition in the health services. The objective of the present study is to investigate the function of the immuno-pineal axis in chronic tension headache, focussed on the neuro-immune regulatory dysfunction. In addition, the effect of neuro-stimulation (electroacupuncture) on the function of this axis will also be studied.
This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control.
The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol.
Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. Evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years old,
- •Providing informed consent to participate in the study,
- •Literate,
- •Clinical diagnosis of Chronic Tension-Type Headache according to the International Headache Society.
排除标准
- •Psychiatric or neurologic disorder that unable patient to consent and follow study protocol,
- •De-compensated systemic disease,
- •Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
结局指标
主要结局
Pain Visual Analogue Scale (VAS)
时间窗: An expected average of 3 months. (At baseline and at the end of each intervention period).
The intensity of pain was measured by a 10 cm VAS. The scores range from no pain (zero) to the worst possible pain (10 cm).
次要结局
- Headache Impact Test (HIT-6)(An expected average of 3 months. (At baseline and at the end of each intervention period).)
研究者
Wolnei Caumo
MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab
Hospital de Clinicas de Porto Alegre