Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The tape will be applied on the lumbar area bilateralemten to the spine without creating any
      tension.

      The possible variation in perceived pain in each spinous process is measured with the Wagner
      Force Dial-FDK 20 algometer.

      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.
    

Detailed description: 
      A double-blind randomized clinical trial is designed where subjects with low back pain will
      be selected and blinded to recieve the Magnetic Tape® 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 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.

      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 L1 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 L1 and L5, and then mark it. The tapes are placed on the paravertebral muscles
      leaving the spinous processes uncovered by the tape.

      Patients receive the two interventions on two different days and the tests serve as their own
      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 Lunge test 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 at least one 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.

      Active joint ROM of both ankles is assessed by placing the patient in bipedestation.
      LegMOtion® will be used for to make measurements the Lunge test.

      Neither application has to be painful.
    

Intervention name(s): Magnetic Tape® aplicación; Kinesiology Tape application
Intervention type(s): Device; Device
Intervention description(s): Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine; Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; magnetic tape; algometer; low back pain; leg motion; Mobility; Range of motion