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Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain

Primary Purpose

Back Pain

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

About this trial

This is an interventional treatment trial for Back Pain focused on measuring pain, magnetic tape, algometer, low back pain, leg motion, Mobility, Range of motion

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

Sites / Locations

  • Clínica Dr 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 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

No Intervention

No Intervention

No Intervention

No Intervention

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

No Intervention

Placebo Comparator

Experimental

No Intervention

Placebo Comparator

Experimental

Arm Label

Pre: pain assessment in the spinous processes of the spine with 1kg

Pre: pain assessment in the spinous processes of the spine with 2 kg

Pre: pain assessment in the spinous processes of the spine with 3 kg

Pre: pain assessment in the spinous processes of the spine with maximum pressure

Post Exp: pain assessment in the spinous processes of the spine with 1kg

Post Exp: pain assessment in the spinous processes of the spine with 2kg

Post Exp: pain assessment in the spinous processes of the spine with 3kg

Post Exp: pain assessment in the spinous processes of the spine with maximum pressure

Post Pla: pain assessment in the spinous processes of the spine with 1kg

Post Pla: pain assessment in the spinous processes of the spine with 2kg

Post Pla: pain assessment in the spinous processes of the spine with 3kg

Post Pla: pain assessment in the spinous processes of the spine with maximum pressure

Pre: Right Ankle Dorsiflexion

Post Pla: Right Ankle Dorsiflexion

Post Exp: Right Ankle Dorsiflexion

Pre: Left Ankle Dorsiflexion

Post Pla: Left Ankle Dorsiflexion

Post Exp: Left Ankle Dorsiflexion

Arm Description

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

press on the spinous processes with the algometer perpendicularly.

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Outcomes

Primary Outcome Measures

Pressure
pressure with 1kg, 2kg, 3kg and the maximum pressure in each spinous process.
Range of motion
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise

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
NCT04875273
Brief Title
Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain
Official Title
Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain: RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
September 11, 2022 (Actual)

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
pain, magnetic tape, algometer, low back pain, leg motion, Mobility, Range of motion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pre: pain assessment in the spinous processes of the spine with 1kg
Arm Type
No Intervention
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Pre: pain assessment in the spinous processes of the spine with 2 kg
Arm Type
No Intervention
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Pre: pain assessment in the spinous processes of the spine with 3 kg
Arm Type
No Intervention
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Pre: pain assessment in the spinous processes of the spine with maximum pressure
Arm Type
No Intervention
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Exp: pain assessment in the spinous processes of the spine with 1kg
Arm Type
Experimental
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Exp: pain assessment in the spinous processes of the spine with 2kg
Arm Type
Experimental
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Exp: pain assessment in the spinous processes of the spine with 3kg
Arm Type
Experimental
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Exp: pain assessment in the spinous processes of the spine with maximum pressure
Arm Type
Experimental
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Pla: pain assessment in the spinous processes of the spine with 1kg
Arm Type
Placebo Comparator
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Pla: pain assessment in the spinous processes of the spine with 2kg
Arm Type
Placebo Comparator
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Pla: pain assessment in the spinous processes of the spine with 3kg
Arm Type
Placebo Comparator
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Post Pla: pain assessment in the spinous processes of the spine with maximum pressure
Arm Type
Placebo Comparator
Arm Description
press on the spinous processes with the algometer perpendicularly.
Arm Title
Pre: Right Ankle Dorsiflexion
Arm Type
No Intervention
Arm Description
Range of motion in right ankle dorsiflexion is measured with LegMOtion®
Arm Title
Post Pla: Right Ankle Dorsiflexion
Arm Type
Placebo Comparator
Arm Description
Range of motion in right ankle dorsiflexion is measured with LegMOtion®
Arm Title
Post Exp: Right Ankle Dorsiflexion
Arm Type
Experimental
Arm Description
Range of motion in right ankle dorsiflexion is measured with LegMOtion®
Arm Title
Pre: Left Ankle Dorsiflexion
Arm Type
No Intervention
Arm Description
Range of motion in left ankle dorsiflexion is measured with LegMOtion®
Arm Title
Post Pla: Left Ankle Dorsiflexion
Arm Type
Placebo Comparator
Arm Description
Range of motion in left ankle dorsiflexion is measured with LegMOtion®
Arm Title
Post Exp: Left Ankle Dorsiflexion
Arm Type
Experimental
Arm Description
Range of motion in left ankle dorsiflexion is measured with LegMOtion®
Intervention Type
Device
Intervention Name(s)
Magnetic Tape® aplicación
Intervention Description
Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine
Intervention Type
Device
Intervention Name(s)
Kinesiology Tape application
Intervention Description
Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine
Primary Outcome Measure Information:
Title
Pressure
Description
pressure with 1kg, 2kg, 3kg and the maximum pressure in each spinous process.
Time Frame
Changes in pain when applying pressure on the spinous processes, first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape. It will wait at least one minute to repeat the test.
Title
Range of motion
Description
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise
Time Frame
Assessment System

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 People with neurological diseases Taking any medication that may interact with magnetic fields.
Facility Information:
Facility Name
Clínica Dr 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 Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain

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