Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Back Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to recieve 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 materi...

A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to recieve 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 statistician will also be blinded. 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. 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. The patient will be placed in the prone position and the spinous processes of T11 and L5 will be identified by marking them with a pen. Once L4 is located at the level of the iliac crests, the therapist will palpate the following spinous processes and will count down to the level of T11 and L5, and then mark it. Patients receive the two interventions on two different days and the tests serve as their own 24-hour separate control. 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 be applied Magnetic tape® in their first visit and kinesiology tape or neuromuscular bandage in your next visit. Group B will do the opposite. Before starting the research, a familiarization session will be held so that the assessments are consistent in terms of pain intensities using the VAS scale. To do this, an algometer will be pressed on the posterior deltoid at 2kg, 4kg and 6kg of pressure and later at 1kg, 2kg and 3kg of pressure, the EVA evaluations must coincide with the intensities of the pressures. Familiarization sessions will also be held so that the rest of the tests and evaluations are carried out properly and so that the results have the highest inter-observer reliability. The perceived pain will be evaluated on two different days. The pain assessment in the spinous processes of the spine will be performed with the Wagner Force Dial-FDK 20 algometer, pressing at each level of the spine with 1kg, 2kg, 3kg and the maximum tolerable pressure separated by each measurement in time from 30 seconds to 1 minute. During each press, the subject will rate perceived pain using the Visual Analog Pain Scale (VAS) while the subject is in the prone position. Neither application has to be painful.

Tracking Information

NCT #
NCT04875273
Collaborators
Not Provided
Investigators
Not Provided