Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04893967 |
| Other study ID # |
1622496 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 11, 2021 |
| Est. completion date |
March 1, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Clínica Dr. Francisco Selva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The tape will be applied on the lumbar area bilaterally to the spine without creating any
tension.
The possible variation in the isometric hip strength is measured with the mDurance®, surface
electromyography and the Lafayette® dynamometer. A kinesiology tape was used as a placebo
tape and the magnetic tape was used in a randomized experimental way.
Description:
A doble-blind clinical trial study, is designed where subjects with low back pain will be
selected and blinded to receive 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 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.
To evaluate the isometric force of hip abduction or Hip Stability Isometric Test (HipSIT). A
surface electromyogram and a force dynamometer are used. The electrodes of the surface
electromyogram will be placed on the Tensor Fascia Lata and Gluteus Medius muscles
bilaterally. The patient will be placed in lateral decubitus with 45 ° hip flexion and 90 °
knees. Both lower limbs will be cinched over the distal third of the thigh where the center
of the Lafayette dynamometer will be positioned laterally 5 cm above the knee joint. The
subject will perform the separation of the upper hip while keeping the heels in contact so
that the hip is in 20 ° of abduction, using its maximum force for 5 seconds performing it 4
times resting between tests for 30 seconds and recording the electromyographic activity.
The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.
Subsequently, both hips are assessed again, performing hip abduction again and recording the
strength.
Each subject will be your control since one day a tape will be placed and the next day the
other.
