Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain

NCT ID: NCT04845477

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2022-12-21

Brief Summary

A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. When returning to the initial temperature, you should improve the degrees of mobility again demonstrating that Magnetic tape only acts on the dermal receptors.

The possible variation of the range in movement is measured with the validated program for the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.

Detailed Description

Detailed 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.

Passive joint ROM of both hips is assessed by placing the patient in a supine position with 90º hip and knee flexion, performing passive internal hip rotation. An infrared marker and the video camera are placed perpendicular to the hip joint so that when the lower limb is flexed, the knee coincides with that point so that the measurement is reproducible.

The infrared thermometer is placed on the subject at a height sufficient to frame the iliac fossa to be evaluated.

After recording the passive hip rotation maneuver, the joint ROM will be assessed using the Kinovea® program.

During the same movement, the muscle activation of the movement antagonist ipsilateral adductor longus will be assessed with the surface electromyograph so that it is not activated.

The local temperature variation of the ipsilateral iliac fossa will also be assessed with the infrared thermometer.

Subsequently, a 5-8 cm long by 5 cm wide strip of Magnetic Tape® will be placed over the ipsilateral iliac fossa of the hip with movement limitation to perform the passive internal rotation of the hip again and record the degrees of range of motion.

Next, the tape shall then be removed and a cold pack shall be placed on the skin. After reducing the local temperature, the cold pack shall be removed, the tape shall be reapplied and the passive internal rotation of the hip shall be measured.

The initial temperature shall be returned to the area and the passive internal rotation of the hip shall be recorded again with the tape.

Each subject shall be their own control as one tape shall be applied on one day and the other tape on the following test day.

Neither application has to be painful.

Conditions

Low Back Pain

Study Design

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

Study Groups

internal hip rotation pre measurement

with knee and hip flexion at 90º, internal hip rotation will be performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

internal hip rotation post experimental application measurement

with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

Group Type: EXPERIMENTAL

Magnetic tape

Intervention Type: DEVICE

magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

internal hip rotation post placebo application measurement

with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

Group Type: PLACEBO_COMPARATOR

Kinesiology tape

Intervention Type: DEVICE

kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

Interventions

Magnetic tape

magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

Intervention Type: DEVICE

Kinesiology tape

kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

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: 18 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

Locations

Clinica Francisco Selva

Valencia, , Spain

Countries

Spain

Other Identifiers

23

Identifier Type: -

Identifier Source: org_study_id