Exercise and Manipulative Therapy for Older Persons With Headache
2016年1月26日 更新者:Sureeporn Uthaikhup、Chiang Mai University
A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache but other various frequent intermittent headache types (i.e.
migraine and tension-type headache) in the elderly population.
There has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment.
Thus, the purpose of study investigate the efficacy of physiotherapy treatment for older persons who have headache concomitant with neck pain and musculoskeletal impairment
研究概览
详细说明
Headache is a common health problem that affects quality of life in an older population and imposes substantial economic costs.
Headache changes with age.
Features of headache become less typical and neck pain is more frequently associated with headache in older persons.
We recently demonstrated that the presence of cervical musculoskeletal impairment is not specific to cervicogenic headache (headache caused by the neck).
Rather it was present in various frequent intermittent headache types in elders when compared to elders without headache.
Changes in headache characteristics with age play an important role not only in diagnosis but also in treatment choice.
Impairment in cervical musculoskeletal function found in older persons with headache has implications for headache management choices as the evidence indicates that physiotherapy management methods such as manual therapy and therapeutic exercise are an effective management approach for headache associated with the neck.
Physiotherapy treatment would be a safe therapeutic option and may have a beneficial effect for elders with headache who have neck pain and concomitant cervical musculoskeletal dysfunction.
This is particularly relevant as there are widespread concerns about medication overuse, adverse drug events and drug interactions in older persons.
The effective management of older persons with headache in particular of those with atypical features of headache remains a challenge.
Physiotherapy is indicated in those older persons diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headache.
At present, there has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment.
A clinical trial of treatment of cervical musculoskeletal impairment in older persons with various headache types may help guide management of headache in attempts to lesson medication use and cost in this population.
Physiotherapy management may be a worthy treatment option particularly in older persons with headache who do not respond well to medication.
研究类型
介入性
注册 (实际的)
65
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
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Chiang Mai、泰国
- Department of Physical Therapy, Faculty of Associated Medical Sciences
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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
50年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Volunteers suffering from frequent intermittent headache (either migraine, tension-type headache or cervicogenic headache) at least one per month over a period of 3 months or longer
- Aged 50 years or older, female or male
- A score of ≥ 3/10 on visual analogue scale (VAS) of neck pain
- Evidence of cervical musculoskeletal impairment: restriction in active range of cervical motion in extension and rotation and join tenderness in at least one of the upper joint as detected by manual palpation
Exclusion Criteria:
- Headache diagnosed as following: temporal arteritis, trigeminal neuralgia, cluster headache, chronic paroxysmal hemicrania/hemicranias continua, temporomandibular joint dysfunction
- Other diagnosed disorders: cerebrovascular disease, Parkinson disease, cognitive disturbance
- Previous history of head or neck surgery
- Lack of willingness to receive either pragmatic treatment or usual care
- Physiotherapy or chiropractic treatment for headache in previous 6 months
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 |
|---|---|
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实验性的:Usual care intervention
Primary care as required including medication
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The usual care intervention will include appropriate primary care as required including medication
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实验性的:Physiotherapy treatment
Exercise and manipulative therapy
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Exercise and manipulative therapy treatment for 10 weeks:The treatment intervention consists of two visits per week for the first four weeks (8 treatments) and one visit per week for the last six weeks (6 treatments)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Headache frequency
大体时间:Change from baseline in headache frequency at week 11 and 6 months after intervention
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The number of headache frequency in the past week
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Change from baseline in headache frequency at week 11 and 6 months after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Headache intensity
大体时间:Change from baseline in headache intensity at week 11 and 6 months after intervention
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An average intensity in the past week will be rated on a 1-10 VAS
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Change from baseline in headache intensity at week 11 and 6 months after intervention
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Headache duration
大体时间:Change from baseline in headache duration at week 11 and 6 months after intervention
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The number of hours of headache in the past week
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Change from baseline in headache duration at week 11 and 6 months after intervention
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Neck pain intensity
大体时间:Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Intensity of neck pain will be measured using a 1-10 VAS
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Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Neck pain and disability
大体时间:Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Neck pain and disability will be measured using neck disability index (NDI-Thai version)
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Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Quality of life
大体时间:Change from baseline in quality of life at week 11 and 6 months after intervention
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The Quality of life will be measured using SF-36 (Thai version)
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Change from baseline in quality of life at week 11 and 6 months after intervention
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Medication intake
大体时间:Change from baseline in medication intake at week 11 and 6 months after intervention
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type and dose of all medications taken by subjects will be recorded one week at baseline and prior to follow-up points on a medication diary
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Change from baseline in medication intake at week 11 and 6 months after intervention
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Global assessment of treatment benefit
大体时间:Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
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Changes from baseline in global assessment of treatment benefit at week 11 and 6 months 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:Sureeporn Uthaikhup, Ph.D.、Department of Physical Therapy, Faculty of Associated Medical Sciences
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
2012年12月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2012年11月22日
首先提交符合 QC 标准的
2012年11月26日
首次发布 (估计)
2012年11月29日
研究记录更新
最后更新发布 (估计)
2016年1月28日
上次提交的符合 QC 标准的更新
2016年1月26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.