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Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic Tape® aplication
Kinesiology Tape
Sponsored by
Francisco Selva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, pupil, Magnetic tape®, pinch, Vorteq® system, autonomic nervous system, pain, algometer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Peoplewith neurological diseases
  • Taking any medication that may interact with magnetic fields.

Sites / Locations

  • Clinica Francisco Selva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Pre: pain AP

Pre: pain Pinch test

Pre: pupil diameter

Post Exp: pain AP

Post Exp: pain Pinch test

Post Exp: pupil diameter

Post Pla: pain AP

Post Pla: pain Pinch test

Post Pla: pupil diameter

Arm Description

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

perceived pain over the paravertebral skin at each level of the spine using Pinch test

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

perceived pain over the paravertebral skin at each level of the spine using Pinch test

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

perceived pain over the paravertebral skin at each level of the spine using Pinch test

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Outcomes

Primary Outcome Measures

Pressure
pressure in each spinous process
Pupil reaction
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc)
Pinch test
press the paravertebral skin at each level of the spine with the first three fingers

Secondary Outcome Measures

Full Information

First Posted
April 26, 2021
Last Updated
September 13, 2022
Sponsor
Francisco Selva
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1. Study Identification

Unique Protocol Identification Number
NCT04873726
Brief Title
Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain
Official Title
Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics and infrastructure problems
Study Start Date
July 22, 2022 (Anticipated)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Selva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension. Possible variation in the autonomic nervous system is assessed in the reaction of the pupils. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Detailed 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 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. Later two strips of tape will be placed on the lumbar paravertebral skin. To measure ANS activity during this study the vortex from Micromedical will be used to capture the pupil diameter. Each participant will wear the goggles throughout the measurement phase and will be in a prone position (with the eyes in complete darkness). After the goggles are placed properly the subjects will remain in a quiet room for three minutes to accommodate to the room environment before the pupil measurement. After this, a 60 second pupil recording will be taken. This measurement will serve as the participant's baseline measurement. After the tape placement the pupil will immediately measured again for a duration of 60 seconds. After a 30 second break period in which the subject is able to blink and close the eyes a second 60 second measure of the pupil will be taken. These steps will be repeated so there will be a total of 4 post measure 60 second pupil measurements (post measure 1, 30 sec break, post measure 2, 30 sec break, post measure 3, 30 sec break, post measure 4). Regardless of what tape is used that will be the measurement sequence. After signing the subject informed consent and data protection groups will be formed. There will be two groups. The first group will consist of spinal pain patients. This group will receive both a Magnetic Tape®, and the placebo tape intervention. The second group without back pain will be age matched to the spine group and will receive the Magnetic Tape®. The spine pain patients are given the two interventions on two different days and wills serve as their own control. To prevent the order of the intervention to influence the study results the subjects will be randomized into two different groups, Spine A and Spine B. Spine A will receive the Magnetic Tape® on their first visit and receive a kinesiology tape on their next visit. Spine B will do the opposite. The control group will only receive the intervention tape. After this, the subject will be placed on a treatment table in the prone position. In this position, a physical therapist will provide posterior to anterior pressure applied at the spinous process and the segmental skin pinch test and it will be documented whether this pressure would cause any pain. If any pain is reported, the subject will be asked to rate this pain on a Numerical Pain Rating Scale (NPRS). The pressure was carried out from S3 to C2. Neither application has to be painful.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, pupil, Magnetic tape®, pinch, Vorteq® system, autonomic nervous system, pain, algometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre: pain AP
Arm Type
No Intervention
Arm Description
Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure
Arm Title
Pre: pain Pinch test
Arm Type
No Intervention
Arm Description
perceived pain over the paravertebral skin at each level of the spine using Pinch test
Arm Title
Pre: pupil diameter
Arm Type
No Intervention
Arm Description
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.
Arm Title
Post Exp: pain AP
Arm Type
Experimental
Arm Description
Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure
Arm Title
Post Exp: pain Pinch test
Arm Type
Experimental
Arm Description
perceived pain over the paravertebral skin at each level of the spine using Pinch test
Arm Title
Post Exp: pupil diameter
Arm Type
Experimental
Arm Description
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.
Arm Title
Post Pla: pain AP
Arm Type
Placebo Comparator
Arm Description
Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure
Arm Title
Post Pla: pain Pinch test
Arm Type
Placebo Comparator
Arm Description
perceived pain over the paravertebral skin at each level of the spine using Pinch test
Arm Title
Post Pla: pupil diameter
Arm Type
Placebo Comparator
Arm Description
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.
Intervention Type
Device
Intervention Name(s)
Magnetic Tape® aplication
Intervention Description
Magnetic tape® is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
Intervention Type
Device
Intervention Name(s)
Kinesiology Tape
Intervention Description
Kinesiology tape is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
Primary Outcome Measure Information:
Title
Pressure
Description
pressure in each spinous process
Time Frame
Changes from pressure on spinous processes, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
Title
Pupil reaction
Description
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc)
Time Frame
Changes from pupil diameter, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
Title
Pinch test
Description
press the paravertebral skin at each level of the spine with the first three fingers
Time Frame
Changes from paravertebral pinch test, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Peoplewith neurological diseases Taking any medication that may interact with magnetic fields.
Facility Information:
Facility Name
Clinica Francisco Selva
City
Valencia
ZIP/Postal Code
46008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain

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