Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
2018年11月6日 更新者：In-Hyuk Ha, KMD、Jaseng Medical Foundation
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone.
研究概览
详细说明
A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed by pain and functional disability scales, monitor its safety, and assess the feasibility of and serve as the basis for a full-scale, multicenter trial.
研究类型
介入性
注册 (实际的)
30
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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Seoul、大韩民国
- Jaseng Medical Foundation
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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
19年 至 70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:
- Onset of at least 6 months previous for neck area pain
- Current neck area pain of Numeric Rating Scale (NRS) 5 or higher
- Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent
Exclusion Criteria:
- Pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout)
- Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
- Other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy)
- Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results
- Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases)
- Patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
- History of cervical surgery within the past 3 months
- Pregnancy or plans of pregnancy
- Severe psychopathy
- Participation in other clinical studies
- Inability to give written informed consent
- Other reasons rendering trial participation inappropriate as judged by the researchers
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Doin with Acupuncture
An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).
Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed.
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Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability.
Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.
其他名称：
Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation.
Acupuncture sessions will be conducted 2 times a week for 5 weeks.
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有源比较器：Acupuncture
An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).
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Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation.
Acupuncture sessions will be conducted 2 times a week for 5 weeks.
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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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Change in Northwick Park Neck Pain Questionnaire (NPQ)
大体时间：6 weeks from baseline
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Change in pain and functional disability questionnaire
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6 weeks from baseline
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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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Northwick Park Neck Pain Questionnaire (NPQ)
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Pain and functional disability questionnaire
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Numeric rating scale (NRS) of neck and arm pain
大体时间：Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
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Pain scale
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Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
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Visual analogue scale (VAS) of neck and arm pain
大体时间：Baseline (Week 1), Week 2, 3, 4, 5, 6
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Pain scale
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Baseline (Week 1), Week 2, 3, 4, 5, 6
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Neck Disability Index (NDI)
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Functional disability questionnaire
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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EuroQol-5 Dimension (EQ-5D)
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Health-related quality of life questionnaire
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Patient Global Impression of Change (PGIC)
大体时间：Week 4, 6, 9, 17, 29, 53
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Global, patient-reported outcome
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Week 4, 6, 9, 17, 29, 53
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Short Form Health Survey 12 (SF-12)
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Health-related quality of life questionnaire
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Cost per QALY (quality-adjusted life year)
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Economic evaluation
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Cost per NRS
大体时间：Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Economic evaluation
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Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Drug Consumption
大体时间：Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
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Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g.
physical therapy, injection therapy)
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Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
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Adverse events
大体时间：Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
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Safety outcome
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Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
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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。
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 (实际的)
2017年2月27日
初级完成 (实际的)
2017年8月23日
研究完成 (实际的)
2018年8月22日
研究注册日期
首次提交
2016年12月28日
首先提交符合 QC 标准的
2016年12月30日
首次发布 (估计)
2017年1月4日
研究记录更新
最后更新发布 (实际的)
2018年11月7日
上次提交的符合 QC 标准的更新
2018年11月6日
最后验证
2018年11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.
Doin (conduction exercise)的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的