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

Official title

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

Overview

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

• Device Tape 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
• Drug Topical Anesthetic Cream
  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
• Device Control 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
• Device Moisturizing 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.

Primary outcome measures

• 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)]

Secondary outcome measures (5)

• Mechanical Detection Threshold (Von Frey Filaments) [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)]
• Pressure Pain Threshold (Algometer) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: Immediately Post-intervention after each of the four intervention visits (Visits 1-4)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Basic science

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28538537

Identifiers

NCT: NCT07034456 · Magnetic Tape/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗