Randomized Trial of Cardiovascular Response to Two Manual Techniques Non-thrust Joint Manipulation of the Cervical Spine in Patients With Non-traumatic Mechanical Neck Pain.
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in heart rate
研究概览
简要总结
The aim of the investigators study is to investigate whether posteriorly directed (AP) pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation or lowering in patients with neck pain. The answer will advance the investigators understanding of why manual therapy works.
详细描述
To be included in the study, these subjects with unilateral non-traumatic, non-chronic neck pain (operationally defined as neck pain with mobility deficits lasting less than 3 months) shall have numeric pain rating scale (NPRS) of between 0 and 5 out of 10 as the most painful neck movement even with passive scapular elevation, neck disability index (NDI) of between 16 and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88, and resting heart rate between 60 and 90. Subjects are excluded if they are current smoker, over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood thinners, is taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or associated with headache, radiating pain, and movement coordination impairments. A convenience sample of subjects will be randomly allocated to 1 of 2 groups. Both Group 1: AP and Group 2: LAT will receive posterior pressures and lateral glides respectively to one hypomobile segment. Baseline NPRS, and NDI will be collected at the initial visit. Systolic blood pressure (SBP) and heart rate (HR) will be measured with a OMRON automatic monitor recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the 1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4 minutes after time point #4. After time point #6, a global rating of change (GROC) will immediately be collected based on the most painful neck movement. A finger pulse oximeter will be placed on the subjects' index finger to constantly monitor their pulse rate for slowing heart rate or asystole. The primary author will perform one of the techniques on all subjects. After one visit, a follow-up NPRS, and NDI will be collected again.
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
- Double (Participant, Investigator)
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, non-traumatic, non-chronic mechanical neck pain
- •Numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation)
- •Neck Disability Index between 16-50/100 percent
- •Resting blood pressure between 90/60 and 138/88 mmHg
- •Resting heart rate between 60 and 90 beats per minute
排除标准
- •Current smoker
- •Under 18 years and over 50 years of age
- •History of fainting spells or loss of consciousness
- •Currently on blood thinners
- •Taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease
- •History of spinal surgery
- •Has neck pain classified or associated headache, arm pain, trauma/whiplash
结局指标
主要结局
Change in heart rate
时间窗: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
次要结局
- Change in blood pressure(7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4)
- Global rating of change(Immediately after intervention)
- Change in Numeric Pain Rating Scale(Baseline and within 7 days after the intervention)
- Change in Neck Disability Index(Baseline and 7 days after the intervention)