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

NCT07034456 | Not Yet Recruiting

• 1 other identifier: Magnetic Tape/2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Volunteers

Keywords

Magnetic Tape; Cutaneous Stimulation; Somatosensory System; Blood Flow

Outcome Measures

Primary Outcomes (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

  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)

• 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)

• 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)

• 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)

• 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)

• Assessment of participant blinding post-intervention

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

Study Arms (4)

Placebo Tape with Moisturizing Cream (Crossover)

SHAM COMPARATOR

Participants 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.

Device: Control KinesioTape; Device: Moisturizing Cream (control)

Magnetic Tape with moisturizing cream

EXPERIMENTAL

Participants 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.

Device: Tape with mangetic particles; Device: Moisturizing Cream (control)

Magnetic Tape with anaesthetic cream

EXPERIMENTAL

Participants 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.

Device: Tape with mangetic particles; Drug: Topical Anesthetic Cream

Placebo Tape with Anesthetic Cream

PLACEBO COMPARATOR

Participants 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.

Drug: Topical Anesthetic Cream; Device: Control KinesioTape

Interventions

Tape with mangetic particles DEVICE

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

Magnetic Tape with anaesthetic cream; Magnetic Tape with moisturizing cream

Topical Anesthetic Cream DRUG

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

Magnetic Tape with anaesthetic cream; Placebo Tape with Anesthetic Cream

Control KinesioTape DEVICE

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

Placebo Tape with Anesthetic Cream; Placebo Tape with Moisturizing Cream (Crossover)

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.

Magnetic Tape with moisturizing cream; Placebo Tape with Moisturizing Cream (Crossover)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patricia Beltra Lopez: lead
• Miguel Delicado Miralles: collaborator
• Gustavo Adolfo Sarriá: collaborator
• Enrique Velasco Serna: collaborator

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Central Study Contacts

Patricia Beltrá López, MsC in Science

CONTACT

+34 638594795; beltralopezpatricia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BSc in Physiotherapy. MSc. PhD Candidate in Health Sciences. COFCV Registration No.: 6563

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP