Acupuncture or MBSR for Patients With Fatigue and MS (MS-Fatigue)
2016年1月27日 更新者：Claudia M. Witt、Charite University, Berlin, Germany
Randomized Controlled Trial on the Efficacy of Acupuncture and the Efficacy of Mindfulness-Based Stress Reduction (MBSR) in Patients With Multiple Sclerosis Suffering From Fatigue
The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.
研究概览
详细说明
In multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of patients.
No successful evidence-based therapy exists so far.
The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.
We want to include 141 patients with multiple sclerosis and fatigue.
Participants will be randomised into three groups to compare 1) usual care, 2) usual care plus standardised acupuncture, and 3) usual care plus mindfulness-based stress reduction.
Treatment duration will be 12 weeks.
The primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks, follow-up measurement will be performed after 26 weeks.
Secondary outcomes include other fatigue specific parameters, other MS specific parameters, cost, and physiological, immunological and functional magnetic resonance imaging parameters.
研究类型
介入性
注册 (实际的)
104
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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Berlin、德国、10117
- The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
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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
18年 至 65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:
- female or male
- 18 to 65 years of age
- able to give oral and signed written informed consent
- clinical diagnosis of multiple sclerosis
- fatigue in "multiple sclerosis" for at least 3 months
- other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion
- stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion
- fatigue score of ≥4 on the Fatigue Severity Scale at inclusion
- patient's mental and physical ability to participate in the trial
- willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements
Exclusion Criteria:
- fatigue because of a malignant disease
- acute relapse or cortisone therapy therapy in the last 30 days before inclusion
- EDSS (Extended disability status scale) > 6
- fatigue specific acupuncture in the last 12 months
- during the last 12 months performing of MBSR exercises learnt in the past
- change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion
- other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy)
- for female patients: pregnancy or anticipated pregnancy during the intervention period
- severe acute and or chronic disease which does not allow participation in the therapy
- other limitations which do not allow participation in the therapy
- alcohol or substance abuse
- parallel participation in another clinical trial
- BDI > 29
- contra indications for fMRI session (e.g. metal clips)
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：usual care + acupuncture
standardized acupuncture treatment in addition to usual care
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Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
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实验性的：usual care+mbsr
mindfulness based stress reduction in addition to usual care not recruiting anymore
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Patients of this group receive mindfulness based stress reduction in addition to usual care
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有源比较器：usual care
usual care without additional treatment
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Patients in this group will follow the same treatment for fatigue they received at study entry
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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 |
|---|---|
|
fatigue severity scale
大体时间：12 weeks
|
12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
fatigue severity scale
大体时间：26 weeks
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26 weeks
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modified fatigue impact scale
大体时间：baseline, 8 weeks, 26 weeks
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baseline, 8 weeks, 26 weeks
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therapy response rates
大体时间：12 weeks
|
12 weeks
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expanded disability status scale
大体时间：baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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multipe sclerosis functional composite scale
大体时间：baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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beck depression inventory II
大体时间：baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Body efficacy expectation
大体时间：baseline, 12 weeks, 26 weeks
|
Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself.
It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics and not published, yet.
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baseline, 12 weeks, 26 weeks
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SF-12
大体时间：baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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HAQUAMS
大体时间：baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Costs
大体时间：baseline, 12 weeks, 26 weeks
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Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
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baseline, 12 weeks, 26 weeks
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overall treatment effect
大体时间：12 weeks, 26 weeks
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12 weeks, 26 weeks
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immune parameters
大体时间：baseline, 12 weeks, 26 weeks
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PBMC and proliferationsassays, pro- and antiinflamatory cytokines, axonal damage marker such as neurofilaments and neurotrophic factors like BDNF possible influences on the immune system will be evaluated in an exploratory way. |
baseline, 12 weeks, 26 weeks
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number of serious adverse events
大体时间：12 weeks, 26 weeks
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12 weeks, 26 weeks
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number of suspected adverse reactions
大体时间：12 weeks, 26 weeks
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12 weeks, 26 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
fMRI
大体时间：baseline, 12 weeks, 26 weeks
|
e.g.
functional connectivity in a subgroup of 20 subjects in each group
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baseline, 12 weeks, 26 weeks
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Dynamics of saccade parameters
大体时间：baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
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Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)
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baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
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Qualitative interviews regarding therapy
大体时间：26 weeks
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Part of the patients will be interviewed about the therapies.
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26 weeks
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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：Claudia M Witt, MD、Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
- 首席研究员：Friedemann Paul, MD、The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
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
2013年4月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2013年4月2日
首先提交符合 QC 标准的
2013年5月24日
首次发布 (估计)
2013年5月30日
研究记录更新
最后更新发布 (估计)
2016年1月29日
上次提交的符合 QC 标准的更新
2016年1月27日
最后验证
2016年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MS-Fatigue-13
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.