Possible Mechanisms of Action of Magnetic Tape Through Its Application on the Epidermis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Mechanical pain sensitivity (300g Von Frey monofilament)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young adults (18-35 years old)
- •Participants interested in laser hair removal who have a prior prescription for EMLA cream
排除标准
- •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
研究组 & 干预措施
Placebo Tape with Moisturizing Cream (Crossover)
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.
干预措施: Control KinesioTape (Device)
Placebo Tape with Moisturizing Cream (Crossover)
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.
干预措施: Moisturizing Cream (control) (Device)
Magnetic Tape with moisturizing cream
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.
干预措施: Tape with mangetic particles (Device)
Magnetic Tape with moisturizing cream
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.
干预措施: Moisturizing Cream (control) (Device)
Magnetic Tape with anaesthetic cream
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.
干预措施: Tape with mangetic particles (Device)
Magnetic Tape with anaesthetic cream
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.
干预措施: Topical Anesthetic Cream (Drug)
Placebo Tape with Anesthetic Cream
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.
干预措施: Topical Anesthetic Cream (Drug)
Placebo Tape with Anesthetic Cream
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.
干预措施: Control KinesioTape (Device)
结局指标
主要结局
Mechanical pain sensitivity (300g Von Frey monofilament)
时间窗: 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
次要结局
- 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))
研究者
Patricia Beltra Lopez
BSc in Physiotherapy. MSc. PhD Candidate in Health Sciences. COFCV Registration No.: 6563
Clinica Francisco Ortega Rehabilitacion Avanzada SL