Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.
2021年11月20日 更新者：Sebastián Rodríguez PosadaSebastián Rodríguez Posada、University of Alcala
Association Between Tissue Changes in Lumbar Multifidae and Improvement in Pain and Disability After Dry Needling in Subjects With Nonspecific Low Back Pain. Randomized Clinical Trial.
Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.
研究概览
详细说明
Lower back pain in regarded as the main cause of disability in the world, which has a significant socio-economic impact. Deep dry needling is effective in handling such pain and is one of the techniques of choice by physiotherapists. In this area, the use of ultrasound provides information of interest such as length, thickness, diameter, cross-sectional area or muscle volume, among others.
Objective: Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.
It's a double-blind randomized clinical trial in parallel groups. Patients will be randomly divided into 2 groups. One of them will receive dry needling and the other dry needling placebo. The initial, post-needling and a week after evaluations will be performed by a blinded to the intervention therapist.
研究类型
介入性
注册 (实际的)
70
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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Madrid
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Torrejón De Ardoz、Madrid、西班牙、28850
- Sebastian
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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:
- Age between 18 and 65 years.
- Nonspecific pain in the lumbar region.
Exclusion Criteria:
- Previous surgery in the lumbosacral spine.
- Osteoporosis.
- Needle phobia.
- Neurogenic pain with positive tests or negative symptoms.
- Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases.
- Pregnancy.
- Physiotherapy intervention in the 4 weeks prior to the intervention.
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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安慰剂比较：Control group
Placebo dry needling
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Placebo dry needling will be performed with DongBang DB100 Acupuncture Needles which, upon contact with the patient, retract, hiding in the needle handle.
The patient will be in the prone position with a pillow in the abdominal region.
The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes.
At the point indicated by the evaluator, the placebo needle will be placed initially and the introduction of the needle and its location will be simulated with the ultrasound system.
10 repetitions will be performed.
The needle will be removed by depositing it in a needle container and a compression will be made in the treated area.
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实验性的：Experimental group
Dry needling
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The dry needling will be performed using disposable stainless steel needles (AGU-PUNT needles of size 0.30x50mm or 0.30x60mm depending on the patient) that will be inserted perpendicularly at the point of major hyperalgesia using the Hong technique.
The patient will be in the prone position with a pillow placed in the abdominal region.
The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes.
After this time, the needle will be inserted at the point indicated by the evaluator before reaching the lumbar multifidus by means of echolocation.
Once it is assured that it is in the right place, a total of 10 repetitions are performed.
The needle will be removed by depositing it in a needle container and a compression will be removed in the treated area until hemostasis is achieved.
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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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Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
大体时间：Baseline, immediately post-needling and a week after.
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This scale shows concurrent and predictive validity in the assessment of pain.
A difference of 2 points represents a clinically significant change that exceeds the limits of measurement error.
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Baseline, immediately post-needling and a week after.
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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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Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters
大体时间：Baseline, immediately post-needling and a week after.
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Baseline, immediately post-needling and a week after.
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Histograms using image analysis
大体时间：Baseline, immediately post-needling and a week after.
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Baseline, immediately post-needling and a week after.
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Pressure Pain threshold
大体时间：Baseline, immediately post-needling and a week after.
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It will be measured by using a pressure algometer.
Lumbar multifidus algometry is performed approximately 1.5 cm from the spinous process of the level to be evaluated.
The measurement will be taken 3 times to avoid variability by instructing patients to say verbally when they begin to feel pain.
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Baseline, immediately post-needling and a week after.
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Disability
大体时间：Baseline, immediately post-needling and a week after.
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it will be measured using the Roland-Morris questionnaire.
Values range from 0 (absence of disability) to 24 (maximum level of disability).
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Baseline, immediately post-needling and a week after.
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Contraction time measured in milliseconds with M-mode
大体时间：Baseline, immediately post-needling and a week after.
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The patient performs a hip extension in the prone position
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Baseline, immediately post-needling and a week after.
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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)
2021年10月1日
初级完成 (实际的)
2021年10月8日
研究完成 (实际的)
2021年10月8日
研究注册日期
首次提交
2021年9月14日
首先提交符合 QC 标准的
2021年9月23日
首次发布 (实际的)
2021年10月5日
研究记录更新
最后更新发布 (实际的)
2021年11月23日
上次提交的符合 QC 标准的更新
2021年11月20日
最后验证
2021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.
腰背疼痛的临床试验
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University尚未招聘
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Daiichi Sankyo招聘中
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的
Placebo dry needling的临床试验
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Mila (bMotion Technologies)完全的