Low Back PainNCT04873726
Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain
A study testing Magnetic Tape® aplication and Kinesiology Tape in people with Low 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. Possible variation in the autonomic nervous system is assessed in the reaction of the pupils. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Magnetic Tape® aplication and Kinesiology Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2022to 30 Dec 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
- Peoplewith neurological diseases
- Taking any medication that may interact with magnetic fields.
Trial locations and contacts
1 site in 1 country.
About this study
The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension.
Possible variation in the autonomic nervous system is assessed in the reaction of the pupils. 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 triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to recieve the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) 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 statistician will also be blinded.
The recommendations of the "Reporting of Observational Studies in Epidemiology" (STROBE) 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 T11 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 T11 and L5, and then mark it.
Later two strips of tape will be placed on the lumbar paravertebral skin. To measure ANS activity during this study the vortex from Micromedical will be used to capture the pupil diameter. Each participant will wear the goggles throughout the measurement phase and will be in a prone position (with the eyes in complete darkness). After the goggles are placed properly the subjects will remain in a quiet room for three minutes to accommodate to the room environment before the pupil measurement. After this, a 60 second pupil recording will be taken. This measurement will serve as the participant's baseline measurement. After the tape placement the pupil will immediately measured again for a duration of 60 seconds. After a 30 second break period in which the subject is able to blink and close the eyes a second 60 second measure of the pupil will be taken. These steps will be repeated so there will be a total of 4 post measure 60 second pupil measurements (post measure 1, 30 sec break, post measure 2, 30 sec break, post measure 3, 30 sec break, post measure 4). Regardless of what tape is used that will be the measurement sequence.
After signing the subject informed consent and data protection groups will be formed. There will be two groups. The first group will consist of spinal pain patients. This group will receive both a Magnetic Tape®, and the placebo tape intervention. The second group without back pain will be age matched to the spine group and will receive the Magnetic Tape®. The spine pain patients are given the two interventions on two different days and wills serve as their own control. To prevent the order of the intervention to influence the study results the subjects will be randomized into two different groups, Spine A and Spine B. Spine A will receive the Magnetic Tape® on their first visit and receive a kinesiology tape on their next visit. Spine B will do the opposite. The control group will only receive the intervention tape.
After this, the subject will be placed on a treatment table in the prone position. In this position, a physical therapist will provide posterior to anterior pressure applied at the spinous process and the segmental skin pinch test and it will be documented whether this pressure would cause any pain. If any pain is reported, the subject will be asked to rate this pain on a Numerical Pain Rating Scale (NPRS). The pressure was carried out from S3 to C2.
Neither application has to be painful.
- Conditions
- Low Back Pain
- Being tested
- Magnetic Tape® aplication, Kinesiology Tape
- Keywords
- low back pain, pupil, Magnetic tape®, pinch, Vorteq® system, autonomic nervous system, pain, algometer
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Tape® aplicationDevice
Magnetic tape® is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
Kinesiology TapeDevice
Kinesiology tape is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
| Study group | Role | What they receive |
|---|---|---|
| Pre: pain AP | No intervention | Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure |
| Pre: pain Pinch test | No intervention | perceived pain over the paravertebral skin at each level of the spine using Pinch test |
| Pre: pupil diameter | No intervention | the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. |
| Post Exp: pain AP | Experimental | Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure Receives: Device: Magnetic Tape® aplication |
| Post Exp: pain Pinch test | Experimental | perceived pain over the paravertebral skin at each level of the spine using Pinch test Receives: Device: Magnetic Tape® aplication |
| Post Exp: pupil diameter | Experimental | the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. Receives: Device: Magnetic Tape® aplication |
| Post Pla: pain AP | Placebo comparator | Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure Receives: Device: Kinesiology Tape |
| Post Pla: pain Pinch test | Placebo comparator | perceived pain over the paravertebral skin at each level of the spine using Pinch test Receives: Device: Kinesiology Tape |
| Post Pla: pupil diameter | Placebo comparator | the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. Receives: Device: Kinesiology Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure
pressure in each spinous process
Measured: Changes from pressure on spinous processes, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
Pupil reaction
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc)
Measured: Changes from pupil diameter, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
Pinch test
press the paravertebral skin at each level of the spine with the first three fingers
Measured: Changes from paravertebral pinch test, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start22 Jul 2022 (estimated)
- Primary completion22 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Logistics and infrastructure problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- 0 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
- NCT04873726
- Sponsor's protocol ID
- 5
- Status last verified
- Sep 2022
- First submitted
- 26 Apr 2021
- Last updated
- 14 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape on Autonomic Nervous System in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04873726
- Acronym / sponsor ID
- 5
- Conditions
- Low Back Pain
- Keywords
- low back pain, pupil, Magnetic tape®, pinch, Vorteq® system, autonomic nervous system, pain, algometer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics and infrastructure problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Francisco SelvaUniversity, hospital or other
- Study start
- 22 Jul 2022 (estimated)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 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.
Possible variation in the autonomic nervous system is assessed in the reaction of the pupils. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Detailed description
A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to recieve the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) 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 statistician will also be blinded.
The recommendations of the "Reporting of Observational Studies in Epidemiology" (STROBE) 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 T11 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 T11 and L5, and then mark it.
Later two strips of tape will be placed on the lumbar paravertebral skin. To measure ANS activity during this study the vortex from Micromedical will be used to capture the pupil diameter. Each participant will wear the goggles throughout the measurement phase and will be in a prone position (with the eyes in complete darkness). After the goggles are placed properly the subjects will remain in a quiet room for three minutes to accommodate to the room environment before the pupil measurement. After this, a 60 second pupil recording will be taken. This measurement will serve as the participant's baseline measurement. After the tape placement the pupil will immediately measured again for a duration of 60 seconds. After a 30 second break period in which the subject is able to blink and close the eyes a second 60 second measure of the pupil will be taken. These steps will be repeated so there will be a total of 4 post measure 60 second pupil measurements (post measure 1, 30 sec break, post measure 2, 30 sec break, post measure 3, 30 sec break, post measure 4). Regardless of what tape is used that will be the measurement sequence.
After signing the subject informed consent and data protection groups will be formed. There will be two groups. The first group will consist of spinal pain patients. This group will receive both a Magnetic Tape®, and the placebo tape intervention. The second group without back pain will be age matched to the spine group and will receive the Magnetic Tape®. The spine pain patients are given the two interventions on two different days and wills serve as their own control. To prevent the order of the intervention to influence the study results the subjects will be randomized into two different groups, Spine A and Spine B. Spine A will receive the Magnetic Tape® on their first visit and receive a kinesiology tape on their next visit. Spine B will do the opposite. The control group will only receive the intervention tape.
After this, the subject will be placed on a treatment table in the prone position. In this position, a physical therapist will provide posterior to anterior pressure applied at the spinous process and the segmental skin pinch test and it will be documented whether this pressure would cause any pain. If any pain is reported, the subject will be asked to rate this pain on a Numerical Pain Rating Scale (NPRS). The pressure was carried out from S3 to C2.
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
- 9
| Arm | Type | Receives |
|---|---|---|
| Pre: pain AP | No intervention | –Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure |
| Pre: pain Pinch test | No intervention | –perceived pain over the paravertebral skin at each level of the spine using Pinch test |
| Pre: pupil diameter | No intervention | –the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. |
| Post Exp: pain AP | Experimental | Device: Magnetic Tape® aplicationPain assessment in the spinous processes of the spine with algometer anteroposterior pressure |
| Post Exp: pain Pinch test | Experimental | Device: Magnetic Tape® aplicationperceived pain over the paravertebral skin at each level of the spine using Pinch test |
| Post Exp: pupil diameter | Experimental | Device: Magnetic Tape® aplicationthe pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. |
| Post Pla: pain AP | Placebo comparator | Device: Kinesiology TapePain assessment in the spinous processes of the spine with algometer anteroposterior pressure |
| Post Pla: pain Pinch test | Placebo comparator | Device: Kinesiology Tapeperceived pain over the paravertebral skin at each level of the spine using Pinch test |
| Post Pla: pupil diameter | Placebo comparator | Device: Kinesiology Tapethe pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction. |
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® aplicationMagnetic tape® is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size | Device | Post Exp: pain AP, Post Exp: pain Pinch test, Post Exp: pupil diameter |
| Kinesiology TapeKinesiology tape is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size | Device | Post Pla: pain AP, Post Pla: pain Pinch test, Post Pla: pupil diameter |
Primary outcome
Pressure
Time frame: Changes from pressure on spinous processes, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
pressure in each spinous process
Pupil reaction
Time frame: Changes from pupil diameter, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc)
Pinch test
Time frame: Changes from paravertebral pinch test, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape
press the paravertebral skin at each level of the spine with the first three fingers
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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® aplication and Kinesiology Tape in people with Low 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: withdrawn, as of the sponsor's last update on 14 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 was withdrawn before enrolling participants, so there are no results.
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 from pressure on spinous processes, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape). The study lists 3 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 14 Sep 2022.