Cayenne Pepper Cataplasm - Safety Study

The blood analysis will include standard analysis of hemogram, C-reactive proteins, creatine-kinase, sedimentation, albumin and cortisol. Enzyme-linked immunosorbent assay (ELISA) will include Tumor necrosis factor-Alpha, Interleukin-6, Leukotriene B4 and P-Selectine. Additionally, microRNA analysis will be performed (gene numbers: 1, 21, 23, 25, 103, 126, 133, 146, 155, 199a, 199b, 191, 206, 451.

Systolic and diastolic blood pressure [mmHg], measured at both sides of the body with blood pressure gauge

Heart rate (bpm), measured with heart rate monitor belt.

The Short Form (36) Health Survey (SF-36) is a patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums all questions in their respective section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the higher is the disability.

Pain perception during rest and movement assessed with visual analogue scale (0-10). 0 represents no pain, and 10 represents severe pain.

EQ-5D- 5L questionnaire includes following aspects: mobility, care, usual activities, pain/discomfort, anxiety/depression, crosswalk-index, self-feeling of health. Each aspect is evaluated on a 1-5 scale, with following descriptions of levels: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".

ODI will be used only in LBP arms (Arm 2 and 3). ODI is commonly used by clinicians and researchers to quantify disability for low back pain.

Skin sensory function will be assessed by 2-point discrimination test (which is carried out using two pins, oriented in medial-lateral direction and pressed perpendicularly to the skin, with the medial pin being 3 cm laterally from the L3 spinal process. The subject is asked to report whether he/she felt one or two pins) and mono filament/light touch sensitivity tests (monofilaments calibrated to 0.025, 0.07, 2, 5, and 10 grams The subject is asked to report when he/she felt touching the skin with a monofilament 3 cm laterally from L3 spinal process). The lightest mono filament and the lowest pin inter-distance are take as final outcome measures.

Assessment of total spine flexibility (forward bend test) and separately for the lumbar part (Schober's test) and thoracic part.

Skin temperature [°C] at the site of application (low back) and at the control part of the body (neck), measured with a laser thermometer.