The use of topical over-the-counter (OTC) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. Advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only little information about the efficacy and the physiological mechanisms of topical warming or cooling products. Therefore, the aim of this study is to investigate the local skin characteristics during and after an application of a topical product with a warming or cooling effect.
The use of topical products for local pain relief in chronic or acute musculoskeletal disorders is widely used. Despite the widespread use of these products, there is missing information on the physiological mechanisms and efficacy of topical warming and cooling ointments. Most of the existing literature is about the efficacy of topical non-steroidal anti-inflammatory drug (NSAID)-products on chronic pain in osteoarthritis. Furthermore, one study tested the cooling effect of gels with different menthol concentrations. They found that, regardless of the concentration, the skin temperature was reduced up to one hour post application in the area of application. The aim of our study is to evaluate the change of skin characteristics after a single application of a warming or cooling topical product on healthy subjects. Outcome parameters include skin perfusion, temperature, skin redness and subjective thermal sensation. We only selected products in form of alcohol based ointments, menthol or wintergreen oil. Sprays and patches were excluded. The application area is the unilateral lumbar back region, whereas the contralateral side serves as control area. After an acclimatization period, baseline measurements are performed, followed by standardized application of the topical product. The local skin responses are measured in 10 mins time increments up to one hour.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
90
Axanova hot gel is a topical product with a warming effect. It contains menthol, pine needle oil, wintergreen oil, rosemary oil, eucalyptus oil, incense oil.
Axanova activ gel is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans.
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
Perskindol Classic Gel is a topical product with a revulsive effect. It contains menthol, wintergreen oil, pine needle oil, lemon oil, orange peel oil, lemon bergamot oil, rosemary oil, lavender oil, excipients.
Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
Dolor-X Hot Gel is a topical product with a warming effect. It contains isopropyl alcohol, water, menthol, hyprolose, camphor, trometamol, paprika, wintergreen oil, excipients.
Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
SUPSI
Landquart, Kanton Graubünden, Switzerland
local skin perfusion
local skin perfusion will be measured with a laser speckle instrument
Time frame: during one hour post application
local skin redness
local skin redness (erythema) will be measured with a chromameter
Time frame: during one hour post application
skin surface temperature
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Time frame: during one hour post application
local muscle tissue oxygenation
local muscle tissue oxygenation will be measured with near infrared spectroscopy
Time frame: during one hour post application
subjective temperature sensation
subjective temperature sensation will be evaluated with a thermal comfort questionnaire
Time frame: during one hour post application
skin perfusion directly next to the application area
skin perfusion will be measured with a laser speckle instrument
Time frame: during one hour post application
skin redness directly next to the application area
skin redness (erythema) will be measured with a chromameter
Time frame: during one hour post application
skin temperature directly next to the application area
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Time frame: during one hour post application
muscle tissue oxygenation directly next to the application area
muscle tissue oxygenation will be measured with near infrared spectroscopy
Time frame: during one hour post application
subjective temperature sensation directly next to the application area
subjective temperature sensation will be evaluated with a thermal comfort questionnaire
Time frame: during one hour post application
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