Changes in Blood Flow in the Lower Limb With the Application of Magnetic Tape in Patients With Low Back Pain. Double-blinded Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- peak diastolic velocity (PDV)
研究概览
简要总结
A tape is applied over the lumbar 4th and lumbar 5th levels crosswise in people with low back pain. The possible variation of the arterial flow of the femoral artery is measured with ultrasound. A kinesiology tape was used as placebo tape and Magnetic Tape was used as experimental randomly.
详细描述
A double-blind randomized clinical trial is designed where subjects with low back pain will be selected and blinded to recieve 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 sonographer also does not know if the patient has low back pain or not or 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.
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
- 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
- 否
入选标准
- •The inclusion criteria will be subjects with low back pain aged 18-65 years residing in Valencia who wish to participate in the study.
排除标准
- •not meeting the age requirement, having conditions that would be a contraindication to placing an adhesive bandage on the skin such as allergies, also being pregnant, having a pacemaker or people who have any contraindication of electromagnetic fields, neurological diseases or taking any medication that may interact with magnetic fields.
结局指标
主要结局
peak diastolic velocity (PDV)
时间窗: 1 minute
femoral artery peak diastolic velocity in (cm / s)
resistance index (RI)
时间窗: 1 minute
reflects resistance to arterial flow
peak systolic velocity (PSV)
时间窗: 1 minute
maximum systolic velocity of the femoral artery in (cm / s)
difference between systolic and diastolic (S / D)
时间窗: 1 minute
difference between systolic and diastolic in the femoral artery
pulsatility index (PI)
时间窗: 1 minute
assesses the peripheral resistance of blood vessels
diameter
时间窗: 1 minute
diameter of each artery
次要结局
- Algometria(2 minutes)
研究者
Francisco Selva
PhD physiotherapy
Clínica Dr. Francisco Selva