Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
研究概览
简要总结
The purpose of this study is to evaluate the effects of provoking pain with manual therapy on pain processing in university students with recurrent or chronic neck pain.
详细描述
The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism generated by the pain that manual therapy techniques may elicit in the patient.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •University students
- •Chronic neck pain (persistent pain > 3 months almost every day of the week) or recurrent neck pain (repeated episodes of neck pain starting > 3 months ago with pain-free periods)
- •Non-specific neck pain (pain in the neck region that is not attributable to a known specific such as herniated disc, myelopathy, fractures, spinal stenosis, neoplasm etc. nor is it associated with traumatic causes such as whiplash)
- •Mean NRS score the last week > 2/10 and presence of pain on the day of assesment and treatment
排除标准
- •Signs of radiculopathy or neuropathic pain
- •Neck surgeries
- •Inflammatory rheumatic
- •Neurological, cardiorespiratory, oncological or psychiatric disease
- •Pregnancy
- •Not being able to read Spanish in order to fill in the questionnaires
结局指标
主要结局
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
时间窗: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the tibialis anterior muscle (remote pain-free area) using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in extensor carpi ulnaris PPT to immediate post-intervention
时间窗: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor carpi ulnaris muscle (remote pain-free area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in upper trapezius PPT to immediate post-intervention
时间窗: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor upper trapezius muscle (symptomatic area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in spinous process of C7 PPT to immediate post-intervention
时间窗: At baseline and immediately after the intervention
PPT will be assessed over the spinous process of C7 (cervical innervated-related area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
次要结局
- Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention(At baseline and immediately after the intervention)
- Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention(At baseline and 4 hours after the intervention)
- Change from Baseline in Pain Intensity by NRS to 5 days post-intervention(At baseline and 5 days after the intervention)
- Change from Baseline in Pain Intensity by NRS to 6 days post-intervention(At baseline and 6 days after the intervention)
- Change from Baseline in Pain Intensity by NRS to 3 days post-intervention(At baseline and 3 days after the intervention)
- Change from Baseline in Pain Intensity by NRS to 4 days post-intervention(At baseline and 4 days after the intervention)
- Change from Baseline in Pain Intensity by NRS to 1 day post-intervention(At baseline and 1 day after the intervention)
- Change from Baseline in Pain Intensity by NRS to 2 days post-intervention(At baseline and 2 days after the intervention)
- Change from Baseline in Pain Intensity by NRS to 7 days post-intervention(At baseline and 7 days after the intervention)
- Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention(Immediately after the intervention)
- Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention(7 days after the intervention)
- Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention(At baseline and immediately after the intervention)
- Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention(At baseline and immediately after the intervention)
- Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention(At baseline and immediately after the intervention)
- Change from Baseline in Cold Pain Intensity to immediate post-intervention(At baseline and immediately after the intervention)
研究者
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos