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Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic Tape
kinesiology tape
Sponsored by
Clínica Dr. 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 strength, pain, low back pain, dynamometer, abduction, surface electromyogram, magnetic tape, kinesiology tape, Hip Stability Isometric Test (HipSIT)

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 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

No Intervention

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

No Intervention: RMS mean hip abduction, dynamometer

No Intervention: Average force hip abduction, dynamometer

No Intervention: Time to reach peak force hip abduction, dynamometer

No Intervention: RMS mean hip abduction, surface electromyogram

No Intervention: RMS mean per second hip abduction, surface electromyogram

No Intervention: Max. contraction test hip abduction, surface electromyogram

Experimental: peak force hip abduction, dynamometer

Experimental: Average force hip abduction, dynamometer

Experimental: time to maximum force hip abduction, dynamometer

Experimental: RMS mean hip abduction, surface electromyogram

Experimental: RMS mean per second hip abduction, surface electromyogram

Experimental: Max. contraction test hip abduction, surface electromyogram

Placebo: peak force hip abduction, dynamometer

Placebo: Average force hip abduction, dynamometer

Placebo: Time to reach peak force hip abduction, dynamometer

Placebo: RMS mean hip abduction, surface electromyogram

Placebo: RMS mean per second hip abduction, surface electromyogram

Placebo: Max. contraction test hip abduction, surface electromyogram

Arm Description

Isometric peak force hip abduction pre measurement. No tape.

Isometric average force hip abduction pre measurement. No tape.

Time to reach peak force hip abduction pre measurement. No tape.

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape.

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape.

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape.

Isometric peak force hip abduction post experimental application measurement with Magnetic Tape application

Isometric average force hip abduction post experimental application measurement with Magnetic Tape application

Time to maximum force hip abduction post experimental application measurement with Magnetic Tape application

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application.

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application.

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application.

Isometric peak force hip abduction post placebo measurement with kinesiology tape application

Isometric average force hip abduction post placebo application measurement with kinesiology tape application

Time to reach peak force hip abduction post placebo application measurement with kinesiology tape application

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application.

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application.

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application.

Outcomes

Primary Outcome Measures

muscle fiber activation
Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.
Peak force of hip abduction
Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Average force of hip abduction
Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.
Time to reach peak force of hip abduction
Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2021
Last Updated
April 7, 2022
Sponsor
Clínica Dr. Francisco Selva
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1. Study Identification

Unique Protocol Identification Number
NCT04893967
Brief Title
Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT
Official Title
Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clínica Dr. 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 bilaterally to the spine without creating any tension. The possible variation in the isometric hip strength is measured with the mDurance®, surface electromyography and the Lafayette® dynamometer. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Detailed Description
A doble-blind clinical trial study, is designed where subjects with low back pain will be selected and blinded to receive 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 patient does not know what tape will be placed on him. 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. The protocol for data collection will be as follows: 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. To evaluate the isometric force of hip abduction or Hip Stability Isometric Test (HipSIT). A surface electromyogram and a force dynamometer are used. The electrodes of the surface electromyogram will be placed on the Tensor Fascia Lata and Gluteus Medius muscles bilaterally. The patient will be placed in lateral decubitus with 45 ° hip flexion and 90 ° knees. Both lower limbs will be cinched over the distal third of the thigh where the center of the Lafayette dynamometer will be positioned laterally 5 cm above the knee joint. The subject will perform the separation of the upper hip while keeping the heels in contact so that the hip is in 20 ° of abduction, using its maximum force for 5 seconds performing it 4 times resting between tests for 30 seconds and recording the electromyographic activity. The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension. Subsequently, both hips are assessed again, performing hip abduction again and recording the strength. Each subject will be your control since one day a tape will be placed and the next day the other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
strength, pain, low back pain, dynamometer, abduction, surface electromyogram, magnetic tape, kinesiology tape, Hip Stability Isometric Test (HipSIT)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
No Intervention: RMS mean hip abduction, dynamometer
Arm Type
No Intervention
Arm Description
Isometric peak force hip abduction pre measurement. No tape.
Arm Title
No Intervention: Average force hip abduction, dynamometer
Arm Type
No Intervention
Arm Description
Isometric average force hip abduction pre measurement. No tape.
Arm Title
No Intervention: Time to reach peak force hip abduction, dynamometer
Arm Type
No Intervention
Arm Description
Time to reach peak force hip abduction pre measurement. No tape.
Arm Title
No Intervention: RMS mean hip abduction, surface electromyogram
Arm Type
No Intervention
Arm Description
Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape.
Arm Title
No Intervention: RMS mean per second hip abduction, surface electromyogram
Arm Type
No Intervention
Arm Description
Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape.
Arm Title
No Intervention: Max. contraction test hip abduction, surface electromyogram
Arm Type
No Intervention
Arm Description
Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape.
Arm Title
Experimental: peak force hip abduction, dynamometer
Arm Type
Experimental
Arm Description
Isometric peak force hip abduction post experimental application measurement with Magnetic Tape application
Arm Title
Experimental: Average force hip abduction, dynamometer
Arm Type
Experimental
Arm Description
Isometric average force hip abduction post experimental application measurement with Magnetic Tape application
Arm Title
Experimental: time to maximum force hip abduction, dynamometer
Arm Type
Experimental
Arm Description
Time to maximum force hip abduction post experimental application measurement with Magnetic Tape application
Arm Title
Experimental: RMS mean hip abduction, surface electromyogram
Arm Type
Experimental
Arm Description
Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application.
Arm Title
Experimental: RMS mean per second hip abduction, surface electromyogram
Arm Type
Experimental
Arm Description
Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application.
Arm Title
Experimental: Max. contraction test hip abduction, surface electromyogram
Arm Type
Experimental
Arm Description
Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application.
Arm Title
Placebo: peak force hip abduction, dynamometer
Arm Type
Placebo Comparator
Arm Description
Isometric peak force hip abduction post placebo measurement with kinesiology tape application
Arm Title
Placebo: Average force hip abduction, dynamometer
Arm Type
Placebo Comparator
Arm Description
Isometric average force hip abduction post placebo application measurement with kinesiology tape application
Arm Title
Placebo: Time to reach peak force hip abduction, dynamometer
Arm Type
Placebo Comparator
Arm Description
Time to reach peak force hip abduction post placebo application measurement with kinesiology tape application
Arm Title
Placebo: RMS mean hip abduction, surface electromyogram
Arm Type
Placebo Comparator
Arm Description
Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application.
Arm Title
Placebo: RMS mean per second hip abduction, surface electromyogram
Arm Type
Placebo Comparator
Arm Description
Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application.
Arm Title
Placebo: Max. contraction test hip abduction, surface electromyogram
Arm Type
Placebo Comparator
Arm Description
Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application.
Intervention Type
Device
Intervention Name(s)
Magnetic Tape
Intervention Description
Magnetic tape® is applied without creating any tension over low back
Intervention Type
Device
Intervention Name(s)
kinesiology tape
Intervention Description
Kinesiology Tape is applied without creating any tension over low back
Primary Outcome Measure Information:
Title
muscle fiber activation
Description
Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.
Time Frame
Changes for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.
Title
Peak force of hip abduction
Description
Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Time Frame
Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Title
Average force of hip abduction
Description
Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.
Time Frame
Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Title
Time to reach peak force of hip abduction
Description
Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Time Frame
Changes from time (seconds) in first assessment before placing the tapes and immediately 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 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

Learn more about this trial

Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT

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