Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04836468 |
| Other study ID # |
4 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2021 |
| Est. completion date |
August 6, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Clínica Dr. Francisco Selva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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® (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.
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.
To standardize the location of the tape application, the patient will be placed in the prone
position and the L4 spinous processes will be identified by marking them with a pen. Once L4
is located at the level of the iliac crests, the therapist will palpate the next spinous
process down to the level of L5, and then it will be marked. The tape will be applied
transversely covering the paravertebral skin at both levels.
Afte this protocol ultrasound will be applied, evaluating the characteristics of blood flow
by means of ultrasound in the common femoral artery using pulsed power doppler. An Alpinion
ECube 12 ultrsound machine with a L3-12H linear probe with a 64 mm footprint will be used.
The variables of Peak systolic PS velocity in (cm/s), peak diastolic velocity (DF) in (cm/s),
the difference between distolic an systolic (S/D), the pulsatility index (PI), the resistance
index (IR) and the artery diameter in (cm) will be taken.
To assess pressure pain in the spinous processes, a Wagner Force Dial - FDK 20 algometer with
a circular contact surface of 1 cm2 will be used. The sensation of perceived pain will be
performed on the paravertebral skin of each level using the pinch technique and assessing it
with the VAS scale. Both the algometer and pinch measurements will be repeated twice at each
level leaving at least 1 minute between measurements.
During the pain measurement phase, each participant will be in the prone position where
assessments will be made from L1 to S4. Afterwards, they will be placed in a supine position
and for three minutes to adjust to the room environment and relax, the ultrasound
measurements were taken. Subsequently, a tape will be placed and the perceived pain, pressure
pain and vascular parameters will be measured again.
