Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      A tape is applied over the inguinal skin nerves in people with low back pain. When placing
      the experimental tape, mobility should be improved and when the area is cooled with the tape,
      rotation should be limited again by inhibiting skin receptors. When returning to the initial
      temperature, you should improve the degrees of mobility again demonstrating that Magnetic
      tape only acts on the dermal receptors.

      The possible variation of the range in movement is measured with the validated program for
      the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape
      and the magnetic tape was used in a randomized experimental way.
    

Detailed description: 
      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.

      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. An infrared marker and
      the video camera are placed perpendicular to the hip joint so that when the lower limb is
      flexed, the knee coincides with that point so that the measurement is reproducible.

      The infrared thermometer is placed on the subject at a height sufficient to frame the iliac
      fossa to be evaluated.

      After recording the passive hip rotation maneuver, the joint ROM will be assessed using the
      Kinovea® program.

      During the same movement, the muscle activation of the movement antagonist ipsilateral
      adductor longus will be assessed with the surface electromyograph so that it is not
      activated.

      The local temperature variation of the ipsilateral iliac fossa will also be assessed with the
      infrared thermometer.

      Subsequently, a 5-8 cm long by 5 cm wide strip of Magnetic Tape® will be placed over the
      ipsilateral iliac fossa of the hip with movement limitation to perform the passive internal
      rotation of the hip again and record the degrees of range of motion.

      Next, the tape shall then be removed and a cold pack shall be placed on the skin. After
      reducing the local temperature, the cold pack shall be removed, the tape shall be reapplied
      and the passive internal rotation of the hip shall be measured.

      The initial temperature shall be returned to the area and the passive internal rotation of
      the hip shall be recorded again with the tape.

      Each subject shall be their own control as one tape shall be applied on one day and the other
      tape on the following test day.

      Neither application has to be painful.
    

Intervention name(s): Magnetic tape; Kinesiology tape
Intervention type(s): Device; Device
Intervention description(s): magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation; kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetic tape; Range on motion; Cold; Cutaneous nerves; Hip; Kinovea® program