The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)
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
- Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
研究概览
简要总结
A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction.
Main outcome measures are balance parameters (force platform).
详细描述
A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant is treated with the same traction devise in the two interventions with just a traction intensity difference.
The care provider who manipulate the traction device can't be blinded to allocation The investigator (performing balance tests) is blinded to the intervention type The outcome assessor is blinded to allocation
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral cervical radiculopathy of greater than three months
排除标准
- •History of surgery or bone-ligament damage to the cervical spine
- •Neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance
- •Inner ear and vestibular pathology
- •Worsening of pain or intolerance in the manual cervical traction test
结局指标
主要结局
Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
时间窗: The CoP sway area assessment is done just before the intervention and 5 minutes after.
The CoP sway area (cm2) correspond to the the area which encloses the data points of the trajectory in relation with the body movement. The CoP sway area is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The Romberg quotient
时间窗: The Romberg quotient assessment is done just before the intervention and 5 minutes after.
The Romberg quotient correpond to the Ratio between Closed and Open Eyes Values of the previous parameters.
Change in static posturographic parameters: CoP position
时间窗: The CoP position assessment is done just before the intervention and 5 minutes after.
The CoP position correspond to the location side in the frontal plan (left or right) and in the sagittal plan (anterior or posterior). The CoP position is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The CoP displacement amplitude
时间窗: The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after.
The CoP displacement amplitude (cm) in the anterior-posterior and medial-lateral trajectory correspond to the amount of body movement during a certain time interval in both trajectories. The CoP displacement amplitude is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The Cop velocity
时间窗: The Cop velocity assessment is done just before the intervention and 5 minutes after.
The Cop velocity (cm/s) correspond to the velocity of movement of the body. The CoP velocity is assessed in two conditions (with open then closed eyes)
次要结局
- Change in grip strength (Kg)(The measure is done just before the intervention and 5 minutes after)
- Change in pain intensity(The pain assessement is done just before the intervention and 5 minutes after)
研究者
Anis Jellad
Professor
University of Monastir