Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04845477 |
| Other study ID # |
23 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2022 |
| Est. completion date |
December 21, 2022 |
Study information
| Verified date |
May 2023 |
| 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 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.
Description:
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.
Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields.
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 ROM of both hips is assessed by placing the patient in a supine position with
90º hip and knee flexion, performing passive internal hip rotation. An infrared marker and
the video camera are placed perpendicular to the hip joint so that when the lower limb is
flexed, the knee coincides with that point so that the measurement is reproducible.
The infrared thermometer is placed on the subject at a height sufficient to frame the iliac
fossa to be evaluated.
After recording the passive hip rotation maneuver, the joint ROM will be assessed using the
Kinovea® program.
During the same movement, the muscle activation of the movement antagonist ipsilateral
adductor longus will be assessed with the surface electromyograph so that it is not
activated.
The local temperature variation of the ipsilateral iliac fossa will also be assessed with the
infrared thermometer.
Subsequently, a 5-8 cm long by 5 cm wide strip of Magnetic Tape® will be placed over the
ipsilateral iliac fossa of the hip with movement limitation to perform the passive internal
rotation of the hip again and record the degrees of range of motion.
Next, the tape shall then be removed and a cold pack shall be placed on the skin. After
reducing the local temperature, the cold pack shall be removed, the tape shall be reapplied
and the passive internal rotation of the hip shall be measured.
The initial temperature shall be returned to the area and the passive internal rotation of
the hip shall be recorded again with the tape.
Each subject shall be their own control as one tape shall be applied on one day and the other
tape on the following test day.
Neither application has to be painful.
