Effects of Magnetic Tape Over Ankle Dorsiflexion 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 ankle dorsiflexion is measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System. 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• Status: Withdrawn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 "Reporting of Observational Studies in Epidemiology" (STROBE) 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. active joint ROM of both ankles is assessed by placing the patient in bipedestation. LegMOtion® will be used for to make measurements.

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

Subsequently, both ankles are assessed again, performing active ankle dorsiflexion 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

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46008
    • Cliniva Dr Francisco Selva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (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: ankle dorsiflexion; ankle dorsiflexion pre measurement with bipedestation position, will be performed
Experimental: Experimental: ankle dorsiflexion; ankle dorsiflexion post measurement with bipedestation position, will be performed	Device: Magnetic Tape®; Magnetic tape® is applied without creating any tension over low back
Placebo Comparator: Placebo: ankle dorsiflexion; ankle dorsiflexion post measurement with bipedestation position, 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
Range of motion	Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System	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): July 4, 2021
• Primary Completion (Anticipated): July 4, 2021
• Study Completion (Anticipated): July 4, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pain; ankle dorsiflexion; Magnetic Tape®; LegMOtion®
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 13

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