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The experiment consists of three experimental sessions conducted on three consecutive days.
In all experimental sessions, the participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress.
In the first session, we will mark six test areas in your face (three on each side on jaw, cheek, and temple, respectively). Thent a series of measure-ments in each test area will be conducted:measurement of the blood flow in the skin and sensitivity tests to pressure, pinprick and stroke with a brush.
In the second session, histamine will be applied in one side of the face. On the other side, cowhage spicules will be applied. After 10 minutes, all the tests will be conducted again.
The third session will be identical to the second. However, instead of histamine and spicules, patches containing capsaicin will be applied. In the other side, we will apply patches with placebo (i.e., a non-active patch). After 20 minutes all the tests will be conducted again.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itch and pain | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histamine | Other | To deliver histamine, standard allergy skin prick test (SPT) lancets are applied |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measuring pain by computerized Visual Analog Scale Scoring | We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable". | Baseline |
| Measuring itch by computerized Visual Analog Scale Scoring | We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable". | Baseline |
| Measuring pain by computerized Visual Analog Scale Scoring | We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable". | Immediately after the intervention |
| Measuring itch by computerized Visual Analog Scale Scoring | We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable". | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial blood perfusion | Superficial blood perfusion (SBP) is measured by a Speckle contrast imager | Baseline |
| Superficial blood perfusion | Superficial blood perfusion (SBP) is measured by a Speckle contrast imager |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Lo Vecchio | Contact | +4521397785 | slv@hst.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Recruiting | Gistrup | Aalborg | 9260 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D006632 | Histamine |
| D002211 | Capsaicin |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Cowhage | Other | The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face |
|
| Capsaicin 8% Patch | Other | Capsaicin patches (dosage form: transdermal patch 8% Qutenza, Astellas) will be applied on 3 squared areas in the face. |
|
| Demo patch | Other | Placebo patch (demo patch, containing the same formulation as the active treatment with the exception of capsaicin) will be applied on 3 squared areas in the face. |
|
| Immediately after the intervention |
| Alloknesis | Measured using a standardized sensory brush exerting a force of 200 to 400 mN. | Baseline |
| Alloknesis | Measured using a standardized sensory brush exerting a force of 200 to 400 mN. | Immediately after the intervention |
| Mechanically evoked itch (MEI) | MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | Baseline |
| Mechanically evoked itch (MEI) | MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | Immediately after the intervention |
| Mechanical Pain Thresholds (MPT) | This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN. | Baseline |
| Mechanical Pain Thresholds (MPT) | This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN. | Immediately after the intervention |
| Mechanical Pain Sensitivity (MPS) | This test is conducted with the same pinprick set used to test the MPT. | Baseline |
| Mechanical Pain Sensitivity (MPS) | This test is conducted with the same pinprick set used to test the MPT. | Immediately after the intervention |
| Cold Detection Thresholds (CDT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Baseline |
| Cold Detection Thresholds (CDT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Immediately after the intervention |
| Warm Detection Thresholds (WDT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Baseline |
| Warm Detection Thresholds (WDT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Immediately after the intervention |
| Cold Pain Thresholds (CPT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Baseline |
| Cold Pain Thresholds (CPT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Immediately after the intervention |
| Heat Pain Thresholds (HPT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Baseline |
| Heat Pain Thresholds (HPT) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Immediately after the intervention |
| Pain to Supra-threshold Heat Stimuli (STHS) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Baseline |
| Pain to Supra-threshold Heat Stimuli (STHS) | The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Immediately after the intervention |
| Pain Catastrophizing Scale (PCS). | The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time). | Baseline |
| Itch Catastrophizing Scale (ICS). | The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time). | Baseline |
| Learned Helplessness Scale (LHS) | The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4). | Baseline |
| Learned Helplessness Scale (LHS) | The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4). | 10 minutes after every induction |
| Pain Catastrophizing Scale (PCS). | The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time). | 10 minutes after induction |
| Itch Catastrophizing Scale (ICS). | The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time). | 10 minutes after induction |
| Depression, Anxiety, Stress Scale (DASS-21) | The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much" | Baseline |
| Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). | The RST-PQ contains in total, 65 items must be answered on a 4-point Likert-type scale | Baseline |
| Difficulties in Emotion Regulation Scale Short Form (DERS-SF) | The questionnaire is an 18-item measure used to identify emotional regulation issues in adults. Participants rate each item on a 5-point Likert scale (from 1 to 5). | Baseline |
| Emotion Regulation Questionnaire (ERQ | This questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), where 4 means (neutral). | Baseline |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D005021 |
| Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004864 | Equipment and Supplies |