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临床试验/NCT02876432
NCT02876432已完成不适用

Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway

Universidad Autónoma Benito Juárez de Oaxaca0 个研究点目标入组 30 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Levels of catecholamines in serum

研究概览

简要总结

Activation of the sympathetic nervous system attenuates inflammation via catecholamines, recent advances in electroacupuncture allow activating critical neuronal networks with the release of catecholamines the aim of this research was to evaluate de effect of electroacupuncture in the activation of sympathetic nervous system and the control of low back pain in athletes

详细描述

Activation of the sympathetic nervous system attenuates inflammation via activation of β2-adrenoreceptors by catecholamines, Electrical stimulation of vagus nerve limits the inflammatory response in several animal models of inflammatory diseases, In addition, voluntary activation of the sympathetic nervous system by meditation, training or breathing techniques limits production of proinflammatory cytokines in vivo during experimental endotoxemia in healthy human volunteers.

Currently there are therapies that effectively antagonize proinflammatory cytokines and control pain, as non-steroidal anti-inflammatory drugs and opioid analgesics, but had serious side effects if used chronically. Therefore, alternative therapies as electroacupuncture, which may limit inflammatory cytokine production more physiologically, are warranted. The aim of this study was to evaluate de effect of electroacupuncture used for attenuation of low back pain in the activation of sympathetic nervous system and leukocyte inflammatory potential.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Non Smokers
  • Acute Low Back Pain (less than 1 month)
  • Non Smokers

排除标准

  • Sciatic Pain
  • Chronic Low Back Pain

研究组 & 干预措施

Device: Electroacupuncture

Experimental

The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation.

Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes

干预措施: Electroacupuncture (Device)

Device: Electroacupuncture

Experimental

The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation.

Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes

干预措施: Sham electroacupuncture (Other)

Device: Sham Electroacupuncture

Sham Comparator

In sham electroacupuncture (Sham) the investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions

干预措施: Electroacupuncture (Device)

Device: Sham Electroacupuncture

Sham Comparator

In sham electroacupuncture (Sham) the investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions

干预措施: Sham electroacupuncture (Other)

Drug: Diclofenac sodium

Active Comparator

100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.

干预措施: Diclofenac sodium (Drug)

结局指标

主要结局

Levels of catecholamines in serum

时间窗: five minutes before Electroacupuncture

Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)

Visual analogue scale

时间窗: before Electroacupuncture Time "0"

in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks

次要结局

  • Levels of catecholamines in serum(five minutes after Electroacupuncture)
  • Visual analogue scale(Five days after Electroacupuncture)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafael Torres Rosas

Full Time Professor Researcher

Universidad Autónoma Benito Juárez de Oaxaca

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