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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Magnetic tape; Device: Kinesiology tape

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46008
    • Clinica Francisco Selva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: internal hip rotation pre measurement; with knee and hip flexion at 90º, internal hip rotation will be performed
Experimental: internal hip rotation post experimental application measurement; with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed	Device: Magnetic tape; magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
Placebo Comparator: internal hip rotation post placebo application measurement; with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation will be performed	Device: Kinesiology tape; kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range on motion	Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program	first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.
Temperature	an infrared thermometer will measure the temperature of the groin area in degrees centigrade	first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.

Collaborators and Investigators

• Sponsor: Francisco Selva

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hip; Cold; Magnetic tape; Range on motion; Cutaneous nerves; Kinovea® program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 23 (SIME)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No