Low Back PainNCT04883112
Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
A study testing Magnetic Tape® 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. The possible variation in the range of motion in ankle dorsiflexion is measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System. 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® 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
- 4 Jul 2021to 4 Jul 2021
- 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
The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension.
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 triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive 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 patient does not know what tape will be placed on him.
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.
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 will be applied. active joint ROM of both ankles is assessed by placing the patient in bipedestation. LegMOtion® will be used for to make measurements.
The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.
Subsequently, both ankles are assessed again, performing active ankle dorsiflexion again and recording the degrees of range of motion.
Each subject will be your control since one day a tape will be placed and the next day the other.
- Conditions
- Low Back Pain
- Being tested
- Magnetic Tape®, Kinesiology Tape
- Keywords
- ankle dorsiflexion, Magnetic Tape®, LegMOtion®, pain
- 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®Device
Magnetic tape® is applied without creating any tension over low back
Kinesiology TapeDevice
Kinesiology tape is applied without creating any tension over low back
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: ankle dorsiflexion | No intervention | ankle dorsiflexion pre measurement with bipedestation position, will be performed |
| Experimental: ankle dorsiflexion | Experimental | ankle dorsiflexion post measurement with bipedestation position, will be performed Receives: Device: Magnetic Tape® |
| Placebo: ankle dorsiflexion | Placebo comparator | ankle dorsiflexion post measurement with bipedestation position, will be performed Receives: Device: Kinesiology Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System
Measured: Changes from Range of motion 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 posted12 May 2021
- Study start4 Jul 2021 (estimated)
- Primary completion4 Jul 2021 (estimated)
- Study completion4 Jul 2021 (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
- NCT04883112
- Sponsor's protocol ID
- 13
- Status last verified
- Apr 2021
- First submitted
- 6 May 2021
- Last updated
- 19 Jul 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04883112
- Acronym / sponsor ID
- 13
- Conditions
- Low Back Pain
- Keywords
- ankle dorsiflexion, Magnetic Tape®, LegMOtion®, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics and infrastructure problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Francisco SelvaUniversity, hospital or other
- Study start
- 4 Jul 2021 (estimated)
- Primary completion
- 4 Jul 2021 (estimated)
- Study completion
- 4 Jul 2021 (estimated)
- First posted
- 12 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 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 triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive 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 patient does not know what tape will be placed on him.
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.
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 will be applied. active joint ROM of both ankles is assessed by placing the patient in bipedestation. LegMOtion® will be used for to make measurements.
The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.
Subsequently, both ankles are assessed again, performing active ankle dorsiflexion again and recording the degrees of range of motion.
Each subject will be your control since one day a tape will be placed and the next day the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Intervention: ankle dorsiflexion | No intervention | –ankle dorsiflexion pre measurement with bipedestation position, will be performed |
| Experimental: ankle dorsiflexion | Experimental | Device: Magnetic Tape®ankle dorsiflexion post measurement with bipedestation position, will be performed |
| Placebo: ankle dorsiflexion | Placebo comparator | Device: Kinesiology Tapeankle dorsiflexion post measurement with bipedestation position, will be performed |
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®Magnetic tape® is applied without creating any tension over low back | Device | Experimental: ankle dorsiflexion |
| Kinesiology TapeKinesiology tape is applied without creating any tension over low back | Device | Placebo: ankle dorsiflexion |
Primary outcome
Range of motion
Time frame: Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System
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 19 Jul 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® 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 19 Jul 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?
Range of motion (time frame: Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.). 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 19 Jul 2022.