Clinical trial NCT04883112: Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
Official title: Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: ankle dorsiflexion
Magnetic Tape®
LegMOtion®
pain
Lead sponsor: Clínica Dr. Francisco Selva
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension.

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.

Detailed description: A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive 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 patient does not know what tape will be placed on him.

The recommendations of the "Reporting of Observational Studies in Epidemiology" (STROBE) 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 will be applied. active joint ROM of both ankles is assessed by placing the patient in bipedestation. LegMOtion® will be used for to make measurements.

The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.

Subsequently, both ankles are assessed again, performing active ankle dorsiflexion again and recording the degrees of range of motion.

Each subject will be your control since one day a tape will be placed and the next day the other.

Eligibility criteria: Inclusion Criteria:

* Subjects with low back pain.
* Subjects aged 18-65 years.

Exclusion Criteria:

* Tape allergies
* Adhesive allergies
* Pregnant
* People with pacemakers
* People who have any contraindication of electromagnetic fields
* People with neurological diseases
* Taking any medication that may interact with magnetic fields.

Primary outcomes:
measure: Range of motion
timeFrame: Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Cliniva Dr Francisco Selva
Study officials:
References: