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临床试验/NCT04662229
NCT04662229已完成不适用

Efficacy of Low Frequency Eco-guided Percutaneous Electric Stimulation on Handgrip Strength: A Single-blinded Pilot Study

University of Castilla-La Mancha2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Hand-grip Strength

研究概览

简要总结

Low-frequency percutaneous electrical stimulation is the application of an electrical current of <1000Hz through acupuncture needles located on the epineurium of the peripheral nervous system.

The hypothesis is that by placing the electrode, needle, closer to the nerve, a greater stimulation of the same will be achieved, thus being able to obtain greater effects. The goal is to determine if this technique has any effect on grip strength in the short term.

详细描述

Single-blind randomized clinical trial of n = 12 healthy subjects. 4 assessments of the grip strength of the non-dominant hand will be made using a digital dynamometer, by a blinded investigator. A V0-pre-intervention, a V1-post-intervention, a V2 at 24 hours and a V3 at 10 days after the intervention. Subjects will be randomly assigned by EPIDAT 3.1, to an experimental group or a control group, with n = 6 each group. In the experimental group, an ultrasound-guided percutaneous electrical stimulation will be performed. With a pointer, a symmetrical biphasic low-frequency current of 10 Hz and 240 microseconds will be applied to the median nerve and ulnar nerve, until reaching the excitomotor threshold, with applications of 10 seconds and rests of 5 seconds until reaching a stimulation of 1 minute. total over each nerve. In the control group, the same invasive procedure will be performed, but no type of electrical stimulation will be applied.

Statistical analysis will be performed by another blinded assessor, using IBM SPSS Statistics 24. A two-factor ANOVA (intervention-time) with Bonferroni correction will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers
  • Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
  • Tolerance to the application of electrotherapy.
  • That they have not diagnosed any pathology.
  • They do not present a contraindication to puncture and / or the application of electric currents.

排除标准

  • Neuromuscular disease.
  • Epilepsy.
  • Trauma, surgery or pain affecting the upper limb.
  • Osteosynthesis material in the upper limb.
  • Diabetes.
  • Cardiovascular disease.
  • Pacemaker or other implanted electrical device.
  • Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
  • Presence of tattoos or other external agent introduced into the treatment or assessment area.
  • Pregnancy

结局指标

主要结局

Hand-grip Strength

时间窗: Time Frame: 10 days after intervention

Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

次要结局

未报告次要终点

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (2)

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