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.
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.
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 group | Role | What they receive |
|---|---|---|
| Pre: pain assessment in the spinous processes of the spine with 1kg | No intervention | press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with 2 kg | No intervention | press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with 3 kg | No intervention | press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with maximum pressure | No intervention | press on the spinous processes with the algometer perpendicularly. |
| Post Exp: pain assessment in the spinous processes of the spine with 1kg | Experimental | press 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 2kg | Experimental | press 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 3kg | Experimental | press 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 pressure | Experimental | press 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 1kg | Placebo comparator | press 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 2kg | Placebo comparator | press 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 3kg | Placebo comparator | press 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 pressure | Placebo comparator | press on the spinous processes with the algometer perpendicularly. Receives: Device: Kinesiology Tape application |
| Pre: Right Ankle Dorsiflexion | No intervention | Range of motion in right ankle dorsiflexion is measured with LegMOtion® |
| Post Pla: Right Ankle Dorsiflexion | Placebo comparator | Range of motion in right ankle dorsiflexion is measured with LegMOtion® Receives: Device: Kinesiology Tape application |
| Post Exp: Right Ankle Dorsiflexion | Experimental | Range of motion in right ankle dorsiflexion is measured with LegMOtion® Receives: Device: Magnetic Tape® aplicación |
| Pre: Left Ankle Dorsiflexion | No intervention | Range of motion in left ankle dorsiflexion is measured with LegMOtion® |
| Post Pla: Left Ankle Dorsiflexion | Placebo comparator | Range of motion in left ankle dorsiflexion is measured with LegMOtion® Receives: Device: Kinesiology Tape application |
| Post Exp: Left Ankle Dorsiflexion | Experimental | Range 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.
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.
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.
- First posted6 May 2021
- Study start21 Mar 2022
- Primary completion8 Sep 2022
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Francisco Selva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Selva, Clínica Dr. Francisco Selva
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain: RCT
- ClinicalTrials.gov ID
- NCT04875273
- Acronym / sponsor ID
- 2
- Conditions
- Back Pain
- Keywords
- pain, magnetic tape, algometer, low back pain, leg motion, Mobility, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Francisco SelvaUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Pre: pain assessment in the spinous processes of the spine with 1kg | No intervention | –press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with 2 kg | No intervention | –press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with 3 kg | No intervention | –press on the spinous processes with the algometer perpendicularly. |
| Pre: pain assessment in the spinous processes of the spine with maximum pressure | No intervention | –press on the spinous processes with the algometer perpendicularly. |
| Post Exp: pain assessment in the spinous processes of the spine with 1kg | Experimental | Device: Magnetic Tape® aplicaciónpress on the spinous processes with the algometer perpendicularly. |
| Post Exp: pain assessment in the spinous processes of the spine with 2kg | Experimental | Device: Magnetic Tape® aplicaciónpress on the spinous processes with the algometer perpendicularly. |
| Post Exp: pain assessment in the spinous processes of the spine with 3kg | Experimental | Device: Magnetic Tape® aplicaciónpress on the spinous processes with the algometer perpendicularly. |
| Post Exp: pain assessment in the spinous processes of the spine with maximum pressure | Experimental | Device: Magnetic Tape® aplicaciónpress on the spinous processes with the algometer perpendicularly. |
| Post Pla: pain assessment in the spinous processes of the spine with 1kg | Placebo comparator | Device: Kinesiology Tape applicationpress on the spinous processes with the algometer perpendicularly. |
| Post Pla: pain assessment in the spinous processes of the spine with 2kg | Placebo comparator | Device: Kinesiology Tape applicationpress on the spinous processes with the algometer perpendicularly. |
| Post Pla: pain assessment in the spinous processes of the spine with 3kg | Placebo comparator | Device: Kinesiology Tape applicationpress on the spinous processes with the algometer perpendicularly. |
| Post Pla: pain assessment in the spinous processes of the spine with maximum pressure | Placebo comparator | Device: Kinesiology Tape applicationpress on the spinous processes with the algometer perpendicularly. |
| Pre: Right Ankle Dorsiflexion | No intervention | –Range of motion in right ankle dorsiflexion is measured with LegMOtion® |
| Post Pla: Right Ankle Dorsiflexion | Placebo comparator | Device: Kinesiology Tape applicationRange of motion in right ankle dorsiflexion is measured with LegMOtion® |
| Post Exp: Right Ankle Dorsiflexion | Experimental | Device: Magnetic Tape® aplicaciónRange of motion in right ankle dorsiflexion is measured with LegMOtion® |
| Pre: Left Ankle Dorsiflexion | No intervention | –Range of motion in left ankle dorsiflexion is measured with LegMOtion® |
| Post Pla: Left Ankle Dorsiflexion | Placebo comparator | Device: Kinesiology Tape applicationRange of motion in left ankle dorsiflexion is measured with LegMOtion® |
| Post Exp: Left Ankle Dorsiflexion | Experimental | Device: Magnetic Tape® aplicaciónRange of motion in left ankle dorsiflexion is measured with LegMOtion® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with low back pain.
- Subjects aged 18-65 years.
Key exclusion criteria (7 listed)
- Tape allergies
- Adhesive allergies
- Pregnant
- People with pacemakers
- People who have any contraindication of electromagnetic fields
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Tape® aplicaciónMagnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine | Device | Post Exp: Left Ankle Dorsiflexion, Post Exp: Right Ankle Dorsiflexion, 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 |
| Kinesiology Tape applicationKinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine | Device | Post Pla: Left Ankle Dorsiflexion, Post Pla: Right Ankle Dorsiflexion, 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 |
Primary outcome
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.
pressure with 1kg, 2kg, 3kg and the maximum pressure in each spinous process.
Range of motion
Time frame: Assessment System
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.