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Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic tape
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 Magnetic tape, Range on motion, Cold, Cutaneous nerves, Hip, Kinovea® program

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

  • Clinica Francisco Selva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Placebo Comparator

Arm Label

internal hip rotation pre measurement

internal hip rotation post experimental application measurement

internal hip rotation post placebo application measurement

Arm Description

with knee and hip flexion at 90º, internal hip rotation will be performed

with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

Outcomes

Primary Outcome Measures

range on motion
Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program
Temperature
an infrared thermometer will measure the temperature of the groin area in degrees centigrade

Secondary Outcome Measures

Full Information

First Posted
April 8, 2021
Last Updated
May 4, 2023
Sponsor
Francisco Selva
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1. Study Identification

Unique Protocol Identification Number
NCT04845477
Brief Title
Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain
Official Title
Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 21, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Magnetic tape, Range on motion, Cold, Cutaneous nerves, Hip, Kinovea® program

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
internal hip rotation pre measurement
Arm Type
No Intervention
Arm Description
with knee and hip flexion at 90º, internal hip rotation will be performed
Arm Title
internal hip rotation post experimental application measurement
Arm Type
Experimental
Arm Description
with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed
Arm Title
internal hip rotation post placebo application measurement
Arm Type
Placebo Comparator
Arm Description
with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation will be performed
Intervention Type
Device
Intervention Name(s)
Magnetic tape
Intervention Description
magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
Intervention Type
Device
Intervention Name(s)
Kinesiology tape
Intervention Description
kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
Primary Outcome Measure Information:
Title
range on motion
Description
Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program
Time Frame
first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.
Title
Temperature
Description
an infrared thermometer will measure the temperature of the groin area in degrees centigrade
Time Frame
first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.

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
Clinica Francisco Selva
City
Valencia
ZIP/Postal Code
46008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain

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