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Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.

2022年7月18日 更新者:Francisco Selva

The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension.

The possible variation in the range of motion in hip flexion is measured with the KInovea program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.

研究概览

详细说明

A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) or placebo Tape. Likewise, the evaluator who puts the Magnetic Tape® does not know what material he is using, as it is supplied by another researcher. The patient does not know what tape will be placed on him.

The recommendations of the "Consolidated Standards of Reporting Trials" (CONSORT) will be followed. All participants will receive a participant information sheet and sign informed consent. Patients aged 18 to 65 years with low back pain will be recruited from different private clinics in the city of Valencia, Spain.

The hypothesis is that when Magnetic Tape® comes into contact with electromagnetic fields such as those generated by living beings, due to the movement of electrical charges (ions), as defined by Ampere's Law, the domains of the tape are oriented or aligned in parallel with the external magnetic field creating a magnetic flux with a north pole and a south pole. This generated field in turn produces a magnetic induction proportional to the variation of the magnetic flux, as defined by the Faraday Law.

This electric potential produces a redistribution of the electric charge (ions) generating a magnetic field due to the orientation of the tape domains, then exerting a force on the moving charges within the electrolyte.

Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields.

The protocol for data collection will be as follows:

After signing the informed consent and data protection, the groups with low back pain will be formed that will receive the application of both Magnetic Tape® and the intervention of a placebo tape. To avoid that the order of the intervention influences the results of the study, the subjects will be randomized into two different groups, Group A and Group B. Group A will receive Magnetic tape® and Group B will do the opposite. The next day the other tape will be applied Passive joint flexion of both hips is assessed by placing the patient in a supine position. The video camera is located paralelar to the hip to make recordings and measurements.

The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.

Subsequently, both hips are assessed again, performing hip flexion again and recording the degrees of range of motion.

Each subject will be your control since one day a tape will be placed and the next day the other.

研究类型

介入性

阶段

  • 不适用

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

16年 至 65年 (孩子、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:

  • Subjects with low back pain.
  • Subjects aged 18-65 years.

Exclusion Criteria:

  • Tape allergies
  • Adhesive allergies
  • Pregnant
  • People with pacemakers
  • People who have any contraindication of electromagnetic fields
  • People with neurological diseases
  • Taking any medication that may interact with magnetic fields.

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:交叉作业
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
无干预:No Intervention:hip flexion
hip flexion pre measurement with extension knee will be performed
实验性的:Experimental: hip flexion
hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed
Magnetic tape® 的应用不会在腰部产生任何张力
安慰剂比较:Placebo Comparator: hip flexion
hip flexion post placebo application measurement with kinesiology tape Application with extension knee will be performed
Kinesiology Tape 的应用不会在腰部产生任何张力

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
Hip flexion
大体时间:Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.
Maximum degrees of hip flexion measured with the Kinovea® program. Validated Video Program
Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.

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 (预期的)

2021年6月22日

初级完成 (预期的)

2021年6月22日

研究完成 (预期的)

2021年6月22日

研究注册日期

首次提交

2021年5月6日

首先提交符合 QC 标准的

2021年5月6日

首次发布 (实际的)

2021年5月10日

研究记录更新

最后更新发布 (实际的)

2022年7月20日

上次提交的符合 QC 标准的更新

2022年7月18日

最后验证

2021年5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

  • 3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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