Cardiovascular Response to Two Manual Techniques for Neck Pain
2016年1月5日 更新者:Azusa Pacific University
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.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
34
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Azusa、California、美国、91784
- 招聘中
- Physical Therapy Department
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接触:
- Michael Wong, DPT
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首席研究员:
- Michael Wong, DPT
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:AP
Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set
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Anterior to posterior pressures
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实验性的:Lateral glides
Lateral glides 5x10 seconds per set with 10 seconds rest between each set
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Lateral glide
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in heart rate
大体时间:7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
|
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in blood pressure
大体时间:7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
|
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
|
|
Change in Numeric Pain Rating Scale
大体时间:Baseline and within 7 days after the intervention
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Baseline and within 7 days after the intervention
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Change in Neck Disability Index
大体时间:Baseline and 7 days after the intervention
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Baseline and 7 days after the intervention
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Global rating of change
大体时间:Immediately after intervention
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Immediately after intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michael Wong, DPT、Azusa Pacific University
- 首席研究员:Emmanuel Yung, DPT、Sacred Heart University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297.
- Bruehl S, Dengler-Crish CM, Smith CA, Walker LS. Hypoalgesia related to elevated resting blood pressure is absent in adolescents and young adults with a history of functional abdominal pain. Pain. 2010 Apr;149(1):57-63. doi: 10.1016/j.pain.2010.01.009. Epub 2010 Feb 1.
- Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Frequency and clinical predictors of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1477-84. doi: 10.1097/01.brs.0000167821.39373.c1.
- Knutson GA. Significant changes in systolic blood pressure post vectored upper cervical adjustment vs resting control groups: a possible effect of the cervicosympathetic and/or pressor reflex. J Manipulative Physiol Ther. 2001 Feb;24(2):101-9. doi: 10.1067/mmt.2001.112564.
- Krediet CT, Jardine DL, Wieling W. Dissection of carotid sinus hypersensitivity: the timing of vagal and vasodepressor effects and the effect of body position. Clin Sci (Lond). 2011 Nov;121(9):389-96. doi: 10.1042/CS20100607.
- Lidegaard O, Lokkegaard E, Jensen A, Skovlund CW, Keiding N. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med. 2012 Jun 14;366(24):2257-66. doi: 10.1056/NEJMoa1111840.
- Lidegaard O, Nielsen LH, Skovlund CW, Skjeldestad FE, Lokkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011 Oct 25;343:d6423. doi: 10.1136/bmj.d6423.
- McGuiness J, Vicenzino B, Wright A. Influence of a cervical mobilization technique on respiratory and cardiovascular function. Man Ther. 1997 Nov;2(4):216-220. doi: 10.1054/math.1997.0302.
- Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernandez-de-Las-Penas C. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from thrust joint manipulation to the cervical spine. J Orthop Sports Phys Ther. 2012 Jul;42(7):577-92. doi: 10.2519/jospt.2012.4243. Epub 2012 May 14.
- Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.
- Egwu MO. Relative therapeutic efficacy of some vertebral mobilization techniques in the management of unilateral cervical spondylosis: a comparative study. Journal of Physical Therapy and Science. 2008;20:103-8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (预期的)
2016年7月1日
研究完成 (预期的)
2016年7月1日
研究注册日期
首次提交
2014年7月15日
首先提交符合 QC 标准的
2014年7月23日
首次发布 (估计)
2014年7月24日
研究记录更新
最后更新发布 (估计)
2016年1月7日
上次提交的符合 QC 标准的更新
2016年1月5日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.