Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04875273 |
| Other study ID # |
2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2022 |
| Est. completion date |
September 11, 2022 |
Study information
| Verified date |
September 2022 |
| 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 bilateralemten to the spine without creating any
tension.
The possible variation in perceived pain in each spinous process is measured with the Wagner
Force Dial-FDK 20 algometer.
The possible variation in the range of motion in ankle dorsiflexion is measured with
LegMOtion® Therapeutic and Corrective Exercise Assessment System.
A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized
experimental way.
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.
The patient will be placed in the prone position and the spinous processes of L1 and L5 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 following spinous processes and will count down to the
level of L1 and L5, and then mark it. The tapes are placed on the paravertebral muscles
leaving the spinous processes uncovered by the tape.
Patients receive the two interventions on two different days and the tests serve as their own
control. 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 be
applied Magnetic tape® in their first visit and kinesiology tape or neuromuscular bandage in
your next visit. Group B will do the opposite.
Before starting the research, a familiarization session will be held so that the assessments
are consistent in terms of pain intensities using the VAS scale. To do this, an algometer
will be pressed on the posterior deltoid at 2kg, 4kg and 6kg of pressure and later at 1kg,
2kg and 3kg of pressure, the EVA evaluations must coincide with the intensities of the
pressures. Familiarization sessions will also be held so that the Lunge test are carried out
properly and so that the results have the highest inter-observer reliability.
The perceived pain will be evaluated on two different days. The pain assessment in the
spinous processes of the spine will be performed with the Wagner Force Dial-FDK 20 algometer,
pressing at each level of the spine with 1kg, 2kg, 3kg and the maximum tolerable pressure
separated by each measurement in time from at least one minute. During each press, the
subject will rate perceived pain using the Visual Analog Pain Scale (VAS) while the subject
is in the prone position.
Active joint ROM of both ankles is assessed by placing the patient in bipedestation.
LegMOtion® will be used for to make measurements the Lunge test.
Neither application has to be painful.
