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

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.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Magnetic Tape; Device: Kinesiology Tape

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: No Intervention:hip flexion; hip flexion pre measurement with extension knee will be performed
Experimental: Experimental: hip flexion; hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed	Device: Magnetic Tape; Magnetic tape® is applied without creating any tension over low back
Placebo Comparator: Placebo Comparator: hip flexion; hip flexion post placebo application measurement with kinesiology tape Application with extension knee will be performed	Device: Kinesiology Tape; Kinesiology Tape is applied without creating any tension over low back

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip flexion	Maximum degrees of hip flexion measured with the Kinovea® program. Validated Video Program	Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.

Collaborators and Investigators

• Sponsor: Francisco Selva

Study record dates

Study Major Dates

• Study Start (Anticipated): June 22, 2021
• Primary Completion (Anticipated): June 22, 2021
• Study Completion (Anticipated): June 22, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pain; range of motion; magnetic tape; hip flexion; Kinovea program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 3

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