Hypertonic Saline, Isotonic Saline
Conditions
Brief summary
In this experiment, the investigators would like to test the following: 1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ? 2. Can these canges correlate with the development of local hyperalgesia? 3. How does the plasma miRNA expression change over a duration of 24 hours post pain induction ? 4. Which mRNA targets are potentially affected by acute pain?
Interventions
OTHERhypertonic saline
The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution
OTHERSaline injection
The participant will be given i.d. in 0.1 mL volumes of a saline solution
PROCEDUREBlood sampling
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
Sponsors
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| miRNA expression over time | Before injection | Plasma miRNA evaluation |
| Protein expression over time | Before injection | Plasma protein evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain: visual analog scale | 20 minutes | 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. |
Countries
Denmark
Outcome results
None listed