Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
2019年9月18日 更新者：Pablo Herrero Gallego、Universidad San Jorge
Study hypothesis:
The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days.
General aims
To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:
- Spasticity
- Muscle stiffness
- Upper limb function
- Patient perceived quality of life
Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.
研究概览
研究类型
介入性
注册 (实际的)
23
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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Zaragoza、西班牙、50830
- Universidad San Jorge
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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
40年 至 90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:
- Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
- Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
- Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
- Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
- Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).
Exclusion Criteria:
- Concomitance of degenerative illnesses which can alter the results.
- Presence of fixed contractures: 4 according to the MMAS score
- Suffering from epileptic fits that are not medically controlled.
- Fear of needles.
- No tolerance to pain caused by needling.
- Those unable to commit to attendance.
- Patients who have received treatment with Botulinum Toxin (BTX A) in the 6 months prior to their inclusion in this study, or those who received said medication or another during the study with the aim of decreasing spasticity.
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：Intervention with DNHS technique
Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
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Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
其他名称：
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假比较器：Sham Dry Needling
Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
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Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
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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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Fugl-Meyer Scale
大体时间：Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Scale measuring Upper Limb Function in stroke patients.
The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results.
The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66).
The sensory assessment measures limb sensation.
Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24.
Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99).
The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .
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Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks 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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Modified Modified Ashworth Scale
大体时间：Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Scale measuring Spasticity/Hypertonia.
This scale ranges from 0 to 4 points for each muscle assessed, where 0 is no hypertonia/spasticity and 4 is the highest hypertonia/spasticity.
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Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Electromyography (EMG)
大体时间：Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Neurophysiological measurements (electromyographic measurements).
The amount of electrical activity will be measured quantitatively, from 0 to an undefined value (depending on every muscle´s activity)
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Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Tonometry (measurement of muscle tone with a device)
大体时间：Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Muscle stiffness or muscle tone.
This device register different parameters like frequency, oscillation, etc that are related to tone, and start from 0 to an undefined number (depending on every muscle).
It is a quantitative measurement.
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Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Quality of Life (Euro QoL5D)
大体时间：Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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Quality of Life.
This scale measures quality of life.
Description: This is a measure of self-reported health outcomes.
It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II).
Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has a 3 point response scale, ranging from worst imaginable health state to best imaginable health state.
Scoring/Interpretation: Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject.
Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).
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Change between baseline (immediately before intervention) and follow-up at 2 weeks 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。
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。
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)
2018年6月19日
初级完成 (实际的)
2018年7月30日
研究完成 (实际的)
2018年9月4日
研究注册日期
首次提交
2018年4月20日
首先提交符合 QC 标准的
2018年6月1日
首次发布 (实际的)
2018年6月6日
研究记录更新
最后更新发布 (实际的)
2019年9月20日
上次提交的符合 QC 标准的更新
2019年9月18日
最后验证
2019年9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.
Dry Needling的临床试验
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Karl Landsteiner Institute for Clinical Epilepsy...AIT Austrian Institute of Technology GmbH; Brainhero GmbH招聘中