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

NCT ID: NCT04893967

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No Intervention: RMS mean hip abduction, dynamometer

Isometric peak force hip abduction pre measurement. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention: Average force hip abduction, dynamometer

Isometric average force hip abduction pre measurement. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention: Time to reach peak force hip abduction, dynamometer

Time to reach peak force hip abduction pre measurement. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention: RMS mean hip abduction, surface electromyogram

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention: RMS mean per second hip abduction, surface electromyogram

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention: Max. contraction test hip abduction, surface electromyogram

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental: peak force hip abduction, dynamometer

Isometric peak force hip abduction post experimental application measurement with Magnetic Tape application

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: Average force hip abduction, dynamometer

Isometric average force hip abduction post experimental application measurement with Magnetic Tape application

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: time to maximum force hip abduction, dynamometer

Time to maximum force hip abduction post experimental application measurement with Magnetic Tape application

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: RMS mean hip abduction, surface electromyogram

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application.

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: RMS mean per second hip abduction, surface electromyogram

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application.

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: Max. contraction test hip abduction, surface electromyogram

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application.

Group Type EXPERIMENTAL

Magnetic Tape

Intervention Type DEVICE

Magnetic tape® is applied without creating any tension over low back

Placebo: peak force hip abduction, dynamometer

Isometric peak force hip abduction post placebo measurement with kinesiology tape application

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: Average force hip abduction, dynamometer

Isometric average force hip abduction post placebo application measurement with kinesiology tape application

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: Time to reach peak force hip abduction, dynamometer

Time to reach peak force hip abduction post placebo application measurement with kinesiology tape application

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: RMS mean hip abduction, surface electromyogram

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application.

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: RMS mean per second hip abduction, surface electromyogram

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application.

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: Max. contraction test hip abduction, surface electromyogram

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application.

Group Type PLACEBO_COMPARATOR

kinesiology tape

Intervention Type DEVICE

Kinesiology Tape is applied without creating any tension over low back

Interventions

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Magnetic Tape

Magnetic tape® is applied without creating any tension over low back

Intervention Type DEVICE

kinesiology tape

Kinesiology Tape is applied without creating any tension over low back

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clínica Dr. Francisco Selva

OTHER

Sponsor Role lead

Responsible Party

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Francisco Selva

Director PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Francisco Selva

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1622496

Identifier Type: -

Identifier Source: org_study_id

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