Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.

NCT ID: NCT04878874

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2021-06-22

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 hip flexion is measured with the KInovea program. 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 "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 will be applied Passive joint flexion of both hips is assessed by placing the patient in a supine position. The video camera is located paralelar to the hip to make recordings and measurements.

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

Subsequently, both hips are assessed again, performing hip flexion 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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

No Intervention:hip flexion

hip flexion pre measurement with extension knee will be performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental: hip flexion

hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed

Group Type: EXPERIMENTAL

Magnetic Tape

Intervention Type: DEVICE

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

Placebo Comparator: hip flexion

hip flexion post placebo application measurement with kinesiology tape Application with extension knee will be performed

Group Type: PLACEBO_COMPARATOR

Kinesiology Tape

Intervention Type: DEVICE

Kinesiology Tape is applied without creating any tension over low back

Interventions

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

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: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Francisco Selva

OTHER

Sponsor Role: lead

Responsible Party

Francisco Selva

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id