Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement of dizziness
研究概览
简要总结
Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular contraction.
详细描述
The selected patients should have neck pain arising from muscle contraction with loss of balance or instability lasting more than 90 days and normal electrooculography. Treatment consisted of placing 10 Helical patches, placebo or active, distributed as follows: two in the upper cervical area, two in the lower cervical area (near the 5th and 6th vertebrae), two in the upper trapezius muscle area (between neck and shoulder), and four in the tender point area (as reported by the patient). Using a Visual Analogue Scale (VAS) and specific questionnaires, the investigators will match pain, muscle tension and dizziness scores from Day 1 to those from Day 15 and Day 30.
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, Care Provider, Outcomes Assessor)
盲法说明
Randomization will be done by lottery. In a container, papers will be placed in the same number of study subjects and, then, the arm in which the subject will be allocated will be drawn. The team physiotherapist is blinded to the individual's allocation 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
- •Cervicogenic Dizziness diagnosis
- •Normal otoneurological examination
- •Signed the informed consent form
- •Neck without other radiological changes, which are not solely attributable to aging (osteophytosis, rectification, disc space reduction).
排除标准
- •Active vestibular disease
- •Traumatic neck injury
- •Neurological
- •Rheumatic or orthopedic diseases not attributable to aging (fractures, tumors) and/or that have surgical indication
- •Somatoform diseases; cognitive limitations.
结局指标
主要结局
Improvement of dizziness
时间窗: 60 days
Improvement of dizziness indices provided by the visual analogue scale. Technically speaking, Visual Analog for Dizziness consists of a horizontal (or vertical) line, usually 100mm in length. The left end of the line signifies no dizziness which is depicted by a smiling face while the right end signifies the worst possible dizziness with a frowning face.
次要结局
- Improvement of cervical neck pain(60 days)
研究者
Roseli Saraiva Moreira Bittar
Clinical Professor
University of Sao Paulo General Hospital