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

Not Applicable

Completed

• Conditions: Isotonic Saline; Hypertonic Saline
• Interventions: Other: hypertonic saline; Other: Saline injection; Procedure: Blood sampling

• Registration Number: NCT04439994
• Lead Sponsor: Aalborg University

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-11-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	hypertonic saline	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.
Isotonic Saline	Blood sampling	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.
Hypertonic saline	Blood sampling	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.
Isotonic Saline	Saline injection	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.

Primary Outcome Measures

Name	Time	Method
miRNA expression over time	24 hours post-injection	Plasma miRNA evaluation
Protein expression over time	24 hours post-injection	Plasma protein evaluation

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

AAlborg University; 🇩🇰 Aalborg, Nordjylland, Denmark

Aalborg University; 🇩🇰 Aalborg, Nordjylland, Denmark