Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment: Study Protocol of a Randomized, Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Peak alpha frequency (Electroencephalography)
研究概览
简要总结
Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue mobility/ motility dysfunctions in general, using different approaches (depending on the target tissue) known as osteopathic manipulative treatment.
Among all the available techniques those ones addressed to the cranial field are most questioned because of the lack of scientific evidence; but the compression of the 4th ventricle technique has been largely studied in clinical trials. Studies have shown that the technique may affect both central and autonomous nervous system, modulating some reflexes (Traube-Hering baro signal), and modifying brain cortex electrical activity through central sensitization in subjects with chronic low back pain.
Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak alpha frequency (electroencephalographic assessment) and promote physical relaxation in subjects in vigil.
详细描述
A randomized controlled crossover trial with blinded assessor was designed to test the hypothesis. A total of 81 participants will be assigned to three treatment conditions, with seven days of washout: compression of the 4th ventricle group; sham compression of the 4th ventricle group; control group (no intervention).
All participants will be recruited at the Outpatient Rehabilitation Service of the University Hospital of Brasília - University of Brasília (Brazil).
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 (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
- •Participants over 18 years old with self-reported nonspecific chronic low back pain will be recruited
排除标准
- •Participants suffering from secondary chronic low back pain,
- •fever, chills, sweating, weight loss, asthenia, anorexia;
- •cardiovascular and respiratory symptoms such as chest pain, dyspnea and cough;
- •headache, dizziness, lightheadedness, fainting, tremors, dysarthria and aphasia;
- •participants who underwent surgery on the spine;
- •diagnosis of any neurological, cardiac, respiratory and rheumatic disease;
- •regular use of drugs with effects on the central nervous system.
结局指标
主要结局
Peak alpha frequency (Electroencephalography)
时间窗: Baseline, 10 minutes.
Baseline: before intervention. 10 minutes: 10 minutes after intervention.
次要结局
- Pain intensity(Baseline, 10 minutes)
研究者
Wagner Rodrigues Martins
Professor, PhD
University of Brasilia