Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04883112
• Other study ID #: 13
• Status: Withdrawn
• Phase: N/A
• Start date: July 4, 2021
• Est. completion date: July 4, 2021

Study information

• Verified date: April 2021
• Source: Clínica Dr. Francisco Selva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 4, 2021
• Est. primary completion date: July 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Magnetic Tape®
Magnetic tape® is applied without creating any tension over low back
• Kinesiology Tape
Kinesiology tape is applied without creating any tension over low back

Locations

Country	Name	City	State
Spain	Cliniva Dr Francisco Selva	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Francisco Selva

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.