Low Back PainNCT04893967
Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT
A study testing Magnetic Tape and kinesiology tape in people with Low Back Pain, run by Clínica Dr. Francisco Selva at 1 site in Spain.
Trial 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. 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
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Oct 2021to 1 Mar 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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Magnetic Tape, kinesiology tape
- Keywords
- strength, pain, low back pain, dynamometer, abduction, surface electromyogram, magnetic tape, kinesiology tape, Hip Stability Isometric Test (HipSIT)
- 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 TapeDevice
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: RMS mean hip abduction, dynamometer | No intervention | Isometric peak force hip abduction pre measurement. No tape. |
| No Intervention: Average force hip abduction, dynamometer | No intervention | Isometric average force hip abduction pre measurement. No tape. |
| No Intervention: Time to reach peak force hip abduction, dynamometer | No intervention | Time to reach peak force hip abduction pre measurement. No tape. |
| No Intervention: RMS mean hip abduction, surface electromyogram | No intervention | Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape. |
| No Intervention: RMS mean per second hip abduction, surface electromyogram | No intervention | Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape. |
| No Intervention: Max. contraction test hip abduction, surface electromyogram | No intervention | Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape. |
| Experimental: peak force hip abduction, dynamometer | Experimental | Isometric peak force hip abduction post experimental application measurement with Magnetic Tape application Receives: Device: Magnetic Tape |
| Experimental: Average force hip abduction, dynamometer | Experimental | Isometric average force hip abduction post experimental application measurement with Magnetic Tape application Receives: Device: Magnetic Tape |
| Experimental: time to maximum force hip abduction, dynamometer | Experimental | Time to maximum force hip abduction post experimental application measurement with Magnetic Tape application Receives: Device: Magnetic Tape |
| Experimental: RMS mean hip abduction, surface electromyogram | Experimental | Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application. Receives: Device: Magnetic Tape |
| Experimental: RMS mean per second hip abduction, surface electromyogram | Experimental | Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application. Receives: Device: Magnetic Tape |
| Experimental: Max. contraction test hip abduction, surface electromyogram | Experimental | Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application. Receives: Device: Magnetic Tape |
| Placebo: peak force hip abduction, dynamometer | Placebo comparator | Isometric peak force hip abduction post placebo measurement with kinesiology tape application Receives: Device: kinesiology tape |
| Placebo: Average force hip abduction, dynamometer | Placebo comparator | Isometric average force hip abduction post placebo application measurement with kinesiology tape application Receives: Device: kinesiology tape |
| Placebo: Time to reach peak force hip abduction, dynamometer | Placebo comparator | Time to reach peak force hip abduction post placebo application measurement with kinesiology tape application Receives: Device: kinesiology tape |
| Placebo: RMS mean hip abduction, surface electromyogram | Placebo comparator | Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application. Receives: Device: kinesiology tape |
| Placebo: RMS mean per second hip abduction, surface electromyogram | Placebo comparator | Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application. Receives: Device: kinesiology tape |
| Placebo: Max. contraction test hip abduction, surface electromyogram | Placebo comparator | Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application. Receives: Device: kinesiology tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle fiber activation
Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.
Measured: Changes for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.
Peak force of hip abduction
Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Measured: Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Average force of hip abduction
Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.
Measured: Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Time to reach peak force of hip abduction
Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Measured: Changes from time (seconds) in first assessment before placing the tapes and immediately 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 posted20 May 2021
- Study start11 Oct 2021
- Primary completion11 Feb 2022
- Study completion1 Mar 2022
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Dr. Francisco Selva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Selva, Clínica Dr. Francisco Selva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893967
- Sponsor's protocol ID
- 1622496
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 14 Apr 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape on Isometric Hip Strength in Patients With Low Back Pain. RCT
- ClinicalTrials.gov ID
- NCT04893967
- Acronym / sponsor ID
- 1622496
- Conditions
- Low Back Pain
- Keywords
- strength, pain, low back pain, dynamometer, abduction, surface electromyogram, magnetic tape, kinesiology tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clínica Dr. Francisco SelvaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 20 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 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.
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 |
|---|---|---|
| No Intervention: RMS mean hip abduction, dynamometer | No intervention | –Isometric peak force hip abduction pre measurement. No tape. |
| No Intervention: Average force hip abduction, dynamometer | No intervention | –Isometric average force hip abduction pre measurement. No tape. |
| No Intervention: Time to reach peak force hip abduction, dynamometer | No intervention | –Time to reach peak force hip abduction pre measurement. No tape. |
| No Intervention: RMS mean hip abduction, surface electromyogram | No intervention | –Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape. |
| No Intervention: RMS mean per second hip abduction, surface electromyogram | No intervention | –Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape. |
| No Intervention: Max. contraction test hip abduction, surface electromyogram | No intervention | –Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape. |
| Experimental: peak force hip abduction, dynamometer | Experimental | Device: Magnetic TapeIsometric peak force hip abduction post experimental application measurement with Magnetic Tape application |
| Experimental: Average force hip abduction, dynamometer | Experimental | Device: Magnetic TapeIsometric average force hip abduction post experimental application measurement with Magnetic Tape application |
| Experimental: time to maximum force hip abduction, dynamometer | Experimental | Device: Magnetic TapeTime to maximum force hip abduction post experimental application measurement with Magnetic Tape application |
| Experimental: RMS mean hip abduction, surface electromyogram | Experimental | Device: Magnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application. |
| Experimental: RMS mean per second hip abduction, surface electromyogram | Experimental | Device: Magnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application. |
| Experimental: Max. contraction test hip abduction, surface electromyogram | Experimental | Device: Magnetic TapeIsometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application. |
| Placebo: peak force hip abduction, dynamometer | Placebo comparator | Device: kinesiology tapeIsometric peak force hip abduction post placebo measurement with kinesiology tape application |
| Placebo: Average force hip abduction, dynamometer | Placebo comparator | Device: kinesiology tapeIsometric average force hip abduction post placebo application measurement with kinesiology tape application |
| Placebo: Time to reach peak force hip abduction, dynamometer | Placebo comparator | Device: kinesiology tapeTime to reach peak force hip abduction post placebo application measurement with kinesiology tape application |
| Placebo: RMS mean hip abduction, surface electromyogram | Placebo comparator | Device: kinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application. |
| Placebo: RMS mean per second hip abduction, surface electromyogram | Placebo comparator | Device: kinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application. |
| Placebo: Max. contraction test hip abduction, surface electromyogram | Placebo comparator | Device: kinesiology tapeIsometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application. |
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 TapeMagnetic tape® is applied without creating any tension over low back | Device | Experimental: Average force hip abduction, dynamometer, Experimental: Max. contraction test hip abduction, surface electromyogram, Experimental: RMS mean hip abduction, surface electromyogram, Experimental: RMS mean per second hip abduction, surface electromyogram, Experimental: peak force hip abduction, dynamometer, Experimental: time to maximum force hip abduction, dynamometer |
| kinesiology tapeKinesiology Tape is applied without creating any tension over low back | Device | Placebo: Average force hip abduction, dynamometer, Placebo: Max. contraction test hip abduction, surface electromyogram, Placebo: RMS mean hip abduction, surface electromyogram, Placebo: RMS mean per second hip abduction, surface electromyogram, Placebo: Time to reach peak force hip abduction, dynamometer, Placebo: peak force hip abduction, dynamometer |
Primary outcome
muscle fiber activation
Time frame: Changes for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.
Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.
Peak force of hip abduction
Time frame: Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
Average force of hip abduction
Time frame: Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.
Time to reach peak force of hip abduction
Time frame: Changes from time (seconds) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.
Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.
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 14 Apr 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 Clínica Dr. 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 14 Apr 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?
muscle fiber activation (time frame: Changes for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.). The study lists 4 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 Apr 2022.