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Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT

Not Applicable
Completed
Conditions
Low Back Pain
Interventions
Device: Magnetic Tape
Device: kinesiology tape
Registration Number
NCT04893967
Lead Sponsor
Clínica Dr. Francisco Selva
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Experimental: Average force hip abduction, dynamometerMagnetic TapeIsometric average force hip abduction post experimental application measurement with Magnetic Tape application
Experimental: RMS mean hip abduction, surface electromyogramMagnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application.
Placebo: Time to reach peak force hip abduction, dynamometerkinesiology tapeTime to reach peak force hip abduction post placebo application measurement with kinesiology tape application
Placebo: Max. contraction test hip abduction, surface electromyogramkinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application.
Placebo: RMS mean per second hip abduction, surface electromyogramkinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application.
Placebo: peak force hip abduction, dynamometerkinesiology tapeIsometric peak force hip abduction post placebo measurement with kinesiology tape application
Experimental: Max. contraction test hip abduction, surface electromyogramMagnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application.
Placebo: Average force hip abduction, dynamometerkinesiology tapeIsometric average force hip abduction post placebo application measurement with kinesiology tape application
Experimental: peak force hip abduction, dynamometerMagnetic TapeIsometric peak force hip abduction post experimental application measurement with Magnetic Tape application
Experimental: time to maximum force hip abduction, dynamometerMagnetic TapeTime to maximum force hip abduction post experimental application measurement with Magnetic Tape application
Experimental: RMS mean per second hip abduction, surface electromyogramMagnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application.
Placebo: RMS mean hip abduction, surface electromyogramkinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application.
Primary Outcome Measures
NameTimeMethod
Peak force of hip abductionChanges from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.

Average force of hip abductionChanges from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.

Time to reach peak force of hip abductionChanges from time (seconds) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.

muscle fiber activationChanges for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.

Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Clinica Francisco Selva

🇪🇸

Valencia, Spain

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