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临床试验/NCT04845477
NCT04845477已完成不适用

Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain

Francisco Selva2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Temperature

研究概览

简要总结

A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. When returning to the initial temperature, you should improve the degrees of mobility again demonstrating that Magnetic tape only acts on the dermal receptors.

The possible variation of the range in movement is measured with the validated program for the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.

详细描述

Detailed Description:

A double-blind randomized clinical trial is designed where subjects with low back pain will be selected and blinded to recieve the Magnetic Tape® 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 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, 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

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

排除标准

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

结局指标

主要结局

Temperature

时间窗: first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.

an infrared thermometer will measure the temperature of the groin area in degrees centigrade

range on motion

时间窗: first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.

Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program

次要结局

未报告次要终点

研究者

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

Francisco Selva

Principal Investigator

Clínica Dr. Francisco Selva

研究点 (2)

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