Healthy Volunteers
Conditions
Keywords
Magnetic Tape, Cutaneous Stimulation, Somatosensory System, Blood Flow
Brief 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. 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
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
Interventions
DEVICETape with mangetic particles
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
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
DEVICEControl KinesioTape
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
DEVICEMoisturizing Cream (control)
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.
Sponsors
Patricia Beltra Lopez
Miguel Delicado Miralles
Gustavo Adolfo Sarriá
Enrique Velasco Serna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy young adults (18-35 years old) * Participants interested in laser hair removal who have a prior prescription for EMLA cream
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical pain sensitivity (300g Von Frey monofilament) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Detection Threshold (Von Frey Filaments) | 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) | 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 |
| Pressure Pain Threshold (Algometer) | Baseline (pre-intervention), Mid-intervention (with tape on) and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4) | 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 |
| Painful pressure sensitivity (algometer) | Baseline (pre-intervention), Mid-intervention (with tape on) and Immediate Post-intervention (immediately after tape removal) at each weekly visit (Visits 1-4) | 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 |
| Blood Flow Assessed by Color Doppler Ultrasound | 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) | 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 |
| Assessment of participant blinding post-intervention | Immediately Post-intervention after each of the four intervention visits (Visits 1-4) | 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 |
Contacts
Primary ContactPatricia Beltrá López, MsC in Science
Outcome results
None listed