Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)

Study Overview
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Brief Summary
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In this experiment, the investigators would like to test the following: Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ? Can these canges correlate with the development of local hyperalgesia? How does the plasma miRNA expression change over a duration of 24 hours post pain induction ? Which mRNA targets are potentially affected by acute pain?

Official Title
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Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain

Conditions
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Hypertonic Saline, Isotonic Saline

Intervention / Treatment
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* Other: hypertonic saline
* Other: Saline injection
* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women in the age 18-80 years Speak and understand English Exclusion Criteria: Acute and chronic pain Pregnancy or breastfeeding Drug addiction defined as the use of cannabis, opioids or other drugs Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.) Lack of ability to cooperate Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs. Skin diseases Consumption of alcohol or painkillers 24 hours before the study days and between these Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups of subjects: one group will receive hypertonic injection (0.1 ml) and the other group will receive isotonic saline injection (0.1 ml)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypertonic saline<br>Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration. | Other: hypertonic saline<br>* The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution<br>Procedure: Blood sampling<br>* Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected<br>|
| Placebo Comparator: Isotonic Saline<br>Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration. | Other: Saline injection<br>* The participant will be given i.d. in 0.1 mL volumes of a saline solution<br>Procedure: Blood sampling<br>* Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA expression over time | Plasma miRNA evaluation | Before injection | 
| miRNA expression over time | Plasma miRNA evaluation | 30 minutes post-injection | 
| miRNA expression over time | Plasma miRNA evaluation | 3 hours post-injection | 
| miRNA expression over time | Plasma miRNA evaluation | 24 hours post-injection | 
| Protein expression over time | Plasma protein evaluation | Before injection | 
| Protein expression over time | Plasma protein evaluation | 30 minutes post-injection | 
| Protein expression over time | Plasma protein evaluation | 3 hours post-injection | 
| Protein expression over time | Plasma protein evaluation | 24 hours post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain: visual analog scale | Pain following capsaicin injection will be monitored for 20 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet. | 20 minutes |