Low Back PainNCT04845477
Effects of Magnetic Tape Over Hip Cutaneous Nerves 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
A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. 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
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2022to 21 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
- 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
A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. When returning to the initial temperature, you should improve the degrees of mobility again demonstrating that Magnetic tape only acts on the dermal receptors.
The possible variation of the range in movement is measured with the validated program for the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Read the detailed description
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.
Passive joint ROM of both hips is assessed by placing the patient in a supine position with 90º hip and knee flexion, performing passive internal hip rotation. An infrared marker and the video camera are placed perpendicular to the hip joint so that when the lower limb is flexed, the knee coincides with that point so that the measurement is reproducible.
The infrared thermometer is placed on the subject at a height sufficient to frame the iliac fossa to be evaluated.
After recording the passive hip rotation maneuver, the joint ROM will be assessed using the Kinovea® program.
During the same movement, the muscle activation of the movement antagonist ipsilateral adductor longus will be assessed with the surface electromyograph so that it is not activated.
The local temperature variation of the ipsilateral iliac fossa will also be assessed with the infrared thermometer.
Subsequently, a 5-8 cm long by 5 cm wide strip of Magnetic Tape® will be placed over the ipsilateral iliac fossa of the hip with movement limitation to perform the passive internal rotation of the hip again and record the degrees of range of motion.
Next, the tape shall then be removed and a cold pack shall be placed on the skin. After reducing the local temperature, the cold pack shall be removed, the tape shall be reapplied and the passive internal rotation of the hip shall be measured.
The initial temperature shall be returned to the area and the passive internal rotation of the hip shall be recorded again with the tape.
Each subject shall be their own control as one tape shall be applied on one day and the other tape on the following test day.
Neither application has to be painful.
- Conditions
- Low Back Pain
- Being tested
- Magnetic tape, Kinesiology tape
- Keywords
- Magnetic tape, Range on motion, Cold, Cutaneous nerves, Hip, Kinovea® program
- Medical subject headings
- Low Back Pain, Common Cold
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 the cutaneous nerves of the groin with less internal hip rotation
Kinesiology tapeDevice
kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
| Study group | Role | What they receive |
|---|---|---|
| internal hip rotation pre measurement | No intervention | with knee and hip flexion at 90º, internal hip rotation will be performed |
| internal hip rotation post experimental application measurement | Experimental | with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed Receives: Device: Magnetic tape |
| internal hip rotation post placebo application measurement | Placebo comparator | with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation 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 on motion
Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program
Measured: first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.
Temperature
an infrared thermometer will measure the temperature of the groin area in degrees centigrade
Measured: first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start19 Sep 2022
- Primary completion19 Dec 2022
- Study completion21 Dec 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
- 32 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
- NCT04845477
- Sponsor's protocol ID
- 23
- Status last verified
- May 2023
- First submitted
- 8 Apr 2021
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape Over Hip Cutaneous Nerves in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04845477
- Acronym / sponsor ID
- 23
- Conditions
- Low Back Pain
- Keywords
- Magnetic tape, Range on motion, Cold, Cutaneous nerves, Hip, Kinovea® program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Francisco SelvaUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 15 Apr 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.
A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. When returning to the initial temperature, you should improve the degrees of mobility again demonstrating that Magnetic tape only acts on the dermal receptors.
The possible variation of the range in movement is measured with the validated program for the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Detailed description
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.
Passive joint ROM of both hips is assessed by placing the patient in a supine position with 90º hip and knee flexion, performing passive internal hip rotation. An infrared marker and the video camera are placed perpendicular to the hip joint so that when the lower limb is flexed, the knee coincides with that point so that the measurement is reproducible.
The infrared thermometer is placed on the subject at a height sufficient to frame the iliac fossa to be evaluated.
After recording the passive hip rotation maneuver, the joint ROM will be assessed using the Kinovea® program.
During the same movement, the muscle activation of the movement antagonist ipsilateral adductor longus will be assessed with the surface electromyograph so that it is not activated.
The local temperature variation of the ipsilateral iliac fossa will also be assessed with the infrared thermometer.
Subsequently, a 5-8 cm long by 5 cm wide strip of Magnetic Tape® will be placed over the ipsilateral iliac fossa of the hip with movement limitation to perform the passive internal rotation of the hip again and record the degrees of range of motion.
Next, the tape shall then be removed and a cold pack shall be placed on the skin. After reducing the local temperature, the cold pack shall be removed, the tape shall be reapplied and the passive internal rotation of the hip shall be measured.
The initial temperature shall be returned to the area and the passive internal rotation of the hip shall be recorded again with the tape.
Each subject shall be their own control as one tape shall be applied on one day and the other tape on the following test day.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| internal hip rotation pre measurement | No intervention | –with knee and hip flexion at 90º, internal hip rotation will be performed |
| internal hip rotation post experimental application measurement | Experimental | Device: Magnetic tapewith Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed |
| internal hip rotation post placebo application measurement | Placebo comparator | Device: Kinesiology tapewith Placebo tape Application with knee and hip flexion at 90º, internal hip rotation 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 tapemagnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation | Device | internal hip rotation post experimental application measurement |
| Kinesiology tapekinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation | Device | internal hip rotation post placebo application measurement |
Primary outcome
range on motion
Time frame: first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.
Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program
Temperature
Time frame: first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.
an infrared thermometer will measure the temperature of the groin area in degrees centigrade
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 6 May 2023.
- 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: finished, as of the sponsor's last update on 6 May 2023. 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?
range on motion (time frame: first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.). 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 6 May 2023.