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Healthy VolunteersNCT07034456

Sensory and Vascular Effects of Kinesio and Magnetic Tape in Healthy Subjects

A study testing Tape with mangetic particles and Topical Anesthetic Cream in people with Healthy Volunteers, run by Patricia Beltra Lopez.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the effects of a tape with magnetic particles versus a control kinesiotape on the skin's sensory and vascular responses in healthy volunteers. The tape is an elastic adhesive strip containing magnetic particles that may modulate sensory nerve endings. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Tape with mangetic particles and Topical Anesthetic Cream
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
Jul 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy young adults (18-35 years old)
  • Participants interested in laser hair removal who have a prior prescription for EMLA cream

Who cannot join

  • Pregnancy
  • Severe illnesses: diabetes, cancer, neurological conditions, depression, etc.
  • Dermatological conditions or skin alterations (large wounds, scars, or tattoos)
  • Allergy to lidocaine or prilocaine (components of EMLA cream)
  • Having exercised within the previous 12 hours
  • Use of any toxic substances or caffeine intake within the previous 12 hours
  • Undergoing laser hair removal in the lumbar, posterior thigh, or anterior forearm areas within the past 24-48 hours

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Patricia Beltrá López, MsC in Science contact

+34 638594795

beltralopezpatricia@gmail.com

About this study

Official title: Possible Mechanisms of Action of Magnetic Tape Through Its Application on the Epidermis

This study aims to evaluate the effects of a tape with magnetic particles versus a control kinesiotape on the skin's sensory and vascular responses in healthy volunteers. The tape is an elastic adhesive strip containing magnetic particles that may modulate sensory nerve endings. The hypothesis is that this magnetic tape can reduce pain and mechanical sensitivity and blood flow in the application area by stimulating cutaneous receptors.

Thirty healthy participants will receive four different combinations of two types of tapes (magnetic vs. placebo) and two creams (anesthetic vs. moisturizing), applied to the lower back in a randomized crossover design. Sensory thresholds and blood flow will be measured at three body regions: close to the application site (lower back), a segmentally related area (posterior thigh), and an unrelated distant site (forearm). Measurements will include pressure pain threshold, mechanical sensitivity, and tactile detection, using standardized tools and Doppler ultrasound

The study will help determine whether the effects of magnetic tape are local or systemic, whether they depend on skin receptor activation, and whether they can be blocked by topical anesthesia

Read the detailed description

This randomized, single-blind, crossover clinical trial investigates the sensory and vascular effects of an elastic adhesive tape containing magnetic particles (Magnetic Tape®) when applied to the skin of healthy volunteers. The study employs a 2x2 factorial design, combining two types of tape (magnetic vs. placebo) and two types of topical cream (anesthetic vs. moisturizing), applied in four different sessions with a one-week washout between conditions. Each participant receives all four combinations in a randomized order

The main hypothesis is that magnetic tape may induce local sensory and vascular changes through the activation of cutaneous sensory afferents. A secondary hypothesis is that these effects may be diminished or abolished by topical anesthetic application, indicating a dependence on superficial nerve activation. A third hypothesis is that any effects will be limited to the dermatome of application, without spreading to distant or segmentally unrelated areas

Sensory testing includes pressure pain threshold (PPT), mechanical pain sensitivity (using numeric rating scale), and tactile detection threshold (using von Frey filaments). These assessments are conducted in three anatomical locations: the lumbar region (close to the application site), the posterior thigh (segmentally related area), and the forearm (unrelated site). Additionally, blood flow is assessed using color Doppler ultrasound. Additionally, the sensitivity of the aplicaction site will be also evaluated to assess the cream effects.

The study aims to improve understanding of the peripheral mechanisms involved in magnetic tape application, clarify the potential neuromodulatory role of cutaneous afferents, and determine whether the observed effects are mediated through local sensory mechanisms

Being tested
Tape with mangetic particles, Topical Anesthetic Cream, Control KinesioTape, Moisturizing Cream (control)
Keywords
Magnetic Tape, Cutaneous Stimulation, Somatosensory System, Blood Flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tape with mangetic particlesDevice

    An elastic adhesive tape containing magnetic particles, designed to be applied directly to the skin. In this study, the tape is applied to the lumbar region. The tape remains in place during standardized sensory and vascular measurements

  • Topical Anesthetic CreamDrug

    EMLA®, a topical anesthetic cream containing lidocaine and prilocaine, will be applied under occlusion prior to tape application during 30 minutes with the aim of anesthetize the cutaneous sensory receptors

  • Control KinesioTapeDevice

    An elastic adhesive tape, designed to be applied directly to the skin. In this study, the tape is applied to the lumbar region. This tape does not content magnetic particles, thus is used as a comparator. The tape remains in place during standardized sensory and vascular measurements

  • Moisturizing Cream (control)Device

    A neutral moisturizing cream (control) will be applied under occlusion prior to tape application during 30 minutes. The application will be blind and use as a placebo vs the anesthetic cream.

Study groups in NCT07034456
Study groupRoleWhat they receive
Placebo Tape with Moisturizing Cream (Crossover)Sham comparatorParticipants will receive Placebo Tape with moisturizing cream Each condition will be applied in a separate session with a one-week washout period. All participants complete every condition in randomized order.
Receives: Device: Control KinesioTape; Device: Moisturizing Cream (control)
Magnetic Tape with moisturizing creamExperimentalParticipants will receive Magnetic Tape with moisturizing cream Each condition will be applied in a separate session with a one-week washout period. All participants complete every condition in randomized order.
Receives: Device: Tape with mangetic particles; Device: Moisturizing Cream (control)
Magnetic Tape with anaesthetic creamExperimentalParticipants will receive Magnetic Tape with anaesthetic cream Each condition will be applied in a separate session with a one-week washout period. All participants complete every condition in randomized order.
Receives: Device: Tape with mangetic particles; Drug: Topical Anesthetic Cream
Placebo Tape with Anesthetic CreamPlacebo comparatorParticipants will receive Placebo Tape with Anesthetic cream Each condition will be applied in a separate session with a one-week washout period. All participants complete every condition in randomized order.
Receives: Drug: Topical Anesthetic Cream; Device: Control KinesioTape

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mechanical pain sensitivity (300g Von Frey monofilament)

    Pain intensity will be assessed using a 300g Von Frey filament applied to the skin. Participants will report pain on an 11-point verbal Numeric Rating Scale (vNRS) from 0 (no pain) to 10 (worst imaginable pain). This measurement is performed in three regions (lumbar area, posterior thigh, and forearm) before and after each intervention. Higher NRS scores indicate greater mechanical pain sensitivity.

    Additionally, it will be applied on intervention location site to assess the cream effect and confirm the anesthetic effects

    Measured: Baseline (pre-intervention), Post-cream (immediately after cream removal), Mid-intervention (with tape on), and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4)

Secondary outcomes (5)
  1. Mechanical Detection Threshold (Von Frey Filaments)

    A set of von Frey filaments of increasing thickness (0.008-300 g) will be applied until the participant detects the stimulus in 3 out of 5 attempts. The smallest filament force (in grams) perceived is recorded as the threshold. Measurements are taken in the lumbar region, posterior thigh, and forearm. Higher thresholds indicate reduced tactile sensitivity.

    Additionally, it will be applied on intervention location site to assess the cream effect and confirm the anesthetic effects

    Measured: Baseline (pre-intervention), Post-cream (immediately after cream removal), Mid-intervention (with tape on), and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4)

  2. Pressure Pain Threshold (Algometer)

    A digital algometer with a 1-cm² probe will be pressed gradually (1 kg/s) against the skin until participants report the first painful sensation. The force (kg/cm²) at which pain is first perceived is the PPT. Measurements are taken twice at each site (lumbar, thigh, forearm), and the average is used for analysis. Higher PPT values indicate lower pain sensitivity

    Measured: Baseline (pre-intervention), Mid-intervention (with tape on) and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4)

  3. Painful pressure sensitivity (algometer)

    A standard pressure of 5 kg is applied with an algometer on the lumbar region, thigh and forearm. Participants rate their pain on a 0-10 verbal Numeric Rating Scale (vNRS). This is done twice and averaged. Higher scores indicate greater evoked pain under a fixed force

    Measured: Baseline (pre-intervention), Mid-intervention (with tape on) and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4)

  4. Blood Flow Assessed by Color Doppler Ultrasound

    Blood flow in the paravertebral lumbar region, thigh and forearm will be assessed using power Doppler ultrasound. Perfusion parameters (e.g., number of color signals, fractional moving blood volume) are recorded over 20-30 seconds at rest, before and after the intervention. Higher perfusion values may indicate increased blood flow

    Measured: Baseline (pre-intervention), Mid-intervention (5 min with tape on) and Immediate Post-intervention (5 min after tape removal) at each weekly visit (Visits 1-4)

  5. Assessment of participant blinding post-intervention

    After each session, participants complete a brief questionnaire indicating whether they believe they received magnetic or placebo tape, and anesthetic or moisturizing cream. The proportion of correct guesses is used to evaluate blinding effectiveness

    Measured: Immediately Post-intervention after each of the four intervention visits (Visits 1-4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
A Clinical trial crossover design. Each participant will receive all four conditions combining two types of tape (magnetic vs. placebo) and two types of cream (anesthetic vs. moisturizing), in randomized order with one-week washout periods between session. This design is similar to 2x2 factorial, but with a repeated measures.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07034456
Sponsor's protocol ID
Magnetic Tape/2025
Status last verified
Jun 2025
First submitted
11 Jun 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will shared the IPD used in the results publication

Publications

  • Smith E, Azzopardi C, Thaker S, Botchu R, Gupta H. Power Doppler in musculoskeletal ultrasound: uses, pitfalls and principles to overcome its shortcomings. J Ultrasound. 2021 Jun;24(2):151-156. doi: 10.1007/s40477-020-00489-0. Epub 2020 Jul 18.

    PubMed 32683646
  • Sillevis R, Cuenca-Zaldivar JN, Fernandez-Carnero S, Garcia-Haba B, Sanchez Romero EA, Selva-Sarzo F. Neuromodulation of the Autonomic Nervous System in Chronic Low Back Pain: A Randomized, Controlled, Crossover Clinical Trial. Biomedicines. 2023 May 26;11(6):1551. doi: 10.3390/biomedicines11061551.

    PubMed 37371646
  • Selva-Sarzo F, Fernandez-Carnero S, Sillevis R, Hernandez-Garces H, Benitez-Martinez JC, Cuenca-Zaldivar JN. The Direct Effect of Magnetic Tape(R) on Pain and Lower-Extremity Blood Flow in Subjects with Low-Back Pain: A Randomized Clinical Trial. Sensors (Basel). 2021 Sep 29;21(19):6517. doi: 10.3390/s21196517.

    PubMed 34640836
  • Rampazo EP, Martignago CCS, de Noronha M, Liebano RE. Transcutaneous electrical stimulation in neck pain: A systematic review and meta-analysis. Eur J Pain. 2022 Jan;26(1):18-42. doi: 10.1002/ejp.1845. Epub 2021 Aug 3.

    PubMed 34288255
  • Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.

    PubMed 32035569
  • Newman JS, Adler RS, Rubin JM. Power Doppler sonography: use in measuring alterations in muscle blood volume after exercise. AJR Am J Roentgenol. 1997 Jun;168(6):1525-30. doi: 10.2214/ajr.168.6.9168718.

    PubMed 9168718
  • Lin S, Zhu B, Huang G, Wang C, Zeng Q, Zhang S. Short-Term Effect of Kinesiotaping on Chronic Nonspecific Low Back Pain and Disability: A Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2020 Feb 7;100(2):238-254. doi: 10.1093/ptj/pzz163.

    PubMed 31696916
  • Lall MP, Restrepo E. The Biopsychosocial Model of Low Back Pain and Patient-Centered Outcomes Following Lumbar Fusion. Orthop Nurs. 2017 May/Jun;36(3):213-221. doi: 10.1097/NOR.0000000000000350.

    PubMed 28538537
  • Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol. 2009 Dec;37(6):477-84. doi: 10.1111/j.1600-0528.2009.00494.x. Epub 2009 Sep 15.

    PubMed 19758415
  • Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.

    PubMed 34115979
  • Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.

    PubMed 34980079
  • Heres HM, Schoots T, Tchang BCY, Rutten MCM, Kemps HMC, van de Vosse FN, Lopata RGP. Perfusion dynamics assessment with Power Doppler ultrasound in skeletal muscle during maximal and submaximal cycling exercise. Eur J Appl Physiol. 2018 Jun;118(6):1209-1219. doi: 10.1007/s00421-018-3850-y. Epub 2018 Mar 22.

    PubMed 29569054
  • Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.

    PubMed 34580864
  • Dori A, Abbasi H, Zaidman CM. Intramuscular blood flow quantification with power doppler ultrasonography. Muscle Nerve. 2016 Nov;54(5):872-878. doi: 10.1002/mus.25108. Epub 2016 Aug 3.

    PubMed 26994405
  • Dias LV, Cordeiro MA, Schmidt de Sales R, Dos Santos MMBR, Korelo RIG, Vojciechowski AS, de Mace do ACB. Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial. J Bodyw Mov Ther. 2021 Jul;27:181-190. doi: 10.1016/j.jbmt.2021.03.005. Epub 2021 Mar 18.

    PubMed 34391232

Questions about this trial

What is this clinical trial studying?

A study testing Tape with mangetic particles and Topical Anesthetic Cream in people with Healthy Volunteers, run by Patricia Beltra Lopez.

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: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patricia Beltrá López, MsC in Science (+34 638594795, beltralopezpatricia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mechanical pain sensitivity (300g Von Frey monofilament) (time frame: Baseline (pre-intervention), Post-cream (immediately after cream removal), Mid-intervention (with tape on), and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07034456, which also lists 21 linked publications.

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 24 Jun 2025.

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