Effects of Magnetic Tape Over Internal Hip Rotation in Patients With Low Back Pain

Sponsor
Francisco Selva (Other)
Overall Status
Suspended
CT.gov ID
NCT04873713
Collaborator
(none)
30
1
3

Study Details

Study Description

Brief 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 internal hip rotation 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Magnetic Tape® aplicación
  • Device: Kinesiology Tape
N/A

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 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. The video camera is located perpendicular (ceiling) to the ipsilateral knee and 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 passive internal hip rotation 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.

Neither application has to be painful.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Magnetic Tape Over Internal Hip Rotation in Patients With Low Back Pain
Anticipated Study Start Date :
Jul 4, 2021
Anticipated Primary Completion Date :
Jul 4, 2021
Anticipated Study Completion Date :
Jul 4, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Intervention: internal hip rotation

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

Experimental: Experimental: internal hip rotation

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® aplicación
Magnetic tape® is applied without creating any tension over low back

Placebo Comparator: Placebo Comparator: 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

Device: Kinesiology Tape
Kinesiology Tape is applied without creating any tension over low back

Outcome Measures

Primary Outcome Measures

  1. Range of motion [Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.]

    Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clínica Dr. Francisco Selva (Fisioterapia) Valencia Spain 46008

Sponsors and Collaborators

  • Francisco Selva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francisco Selva, Principal Investigator, Clínica Dr. Francisco Selva
ClinicalTrials.gov Identifier:
NCT04873713
Other Study ID Numbers:
  • 12409331
First Posted:
May 5, 2021
Last Update Posted:
Jul 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francisco Selva, Principal Investigator, Clínica Dr. Francisco Selva
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021