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Back PainNCT04875273

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

A study testing Magnetic Tape® aplicación and Kinesiology Tape application in people with Back Pain, run by Francisco Selva at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Back Pain
What is being tested?
Magnetic Tape® aplicación and Kinesiology Tape application
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteSpain
Study dates
21 Mar 2022to 11 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with low back pain.
  • Subjects aged 18-65 years.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Clínica Dr Francisco Selva

    Valencia, 46008

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Back Pain
Being tested
Magnetic Tape® aplicación, Kinesiology Tape application
Keywords
pain, magnetic tape, algometer, low back pain, leg motion, Mobility, Range of motion
Medical subject headings
Back Pain, Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Tape® aplicaciónDevice

    Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine

  • Kinesiology Tape applicationDevice

    Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine

Study groups in NCT04875273
Study groupRoleWhat they receive
Pre: pain assessment in the spinous processes of the spine with 1kgNo interventionpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with 2 kgNo interventionpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with 3 kgNo interventionpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with maximum pressureNo interventionpress on the spinous processes with the algometer perpendicularly.
Post Exp: pain assessment in the spinous processes of the spine with 1kgExperimentalpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Magnetic Tape® aplicación
Post Exp: pain assessment in the spinous processes of the spine with 2kgExperimentalpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Magnetic Tape® aplicación
Post Exp: pain assessment in the spinous processes of the spine with 3kgExperimentalpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Magnetic Tape® aplicación
Post Exp: pain assessment in the spinous processes of the spine with maximum pressureExperimentalpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Magnetic Tape® aplicación
Post Pla: pain assessment in the spinous processes of the spine with 1kgPlacebo comparatorpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Kinesiology Tape application
Post Pla: pain assessment in the spinous processes of the spine with 2kgPlacebo comparatorpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Kinesiology Tape application
Post Pla: pain assessment in the spinous processes of the spine with 3kgPlacebo comparatorpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Kinesiology Tape application
Post Pla: pain assessment in the spinous processes of the spine with maximum pressurePlacebo comparatorpress on the spinous processes with the algometer perpendicularly.
Receives: Device: Kinesiology Tape application
Pre: Right Ankle DorsiflexionNo interventionRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Post Pla: Right Ankle DorsiflexionPlacebo comparatorRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Receives: Device: Kinesiology Tape application
Post Exp: Right Ankle DorsiflexionExperimentalRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Receives: Device: Magnetic Tape® aplicación
Pre: Left Ankle DorsiflexionNo interventionRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Post Pla: Left Ankle DorsiflexionPlacebo comparatorRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Receives: Device: Kinesiology Tape application
Post Exp: Left Ankle DorsiflexionExperimentalRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Receives: Device: Magnetic Tape® aplicación

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure

    pressure with 1kg, 2kg, 3kg and the maximum pressure in each spinous process.

    Measured: 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.

  2. Range of motion

    Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise

    Measured: Assessment System

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start21 Mar 2022
  3. Primary completion8 Sep 2022
  4. Study completion11 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875273
Sponsor's protocol ID
2
Status last verified
Sep 2022
First submitted
26 Apr 2021
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Tape® aplicación and Kinesiology Tape application in people with Back Pain, run by Francisco Selva at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.

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