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

Hypertonic Saline Clinical Trial

— miRNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439994
• Other study ID #: N-20200015
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertonic Saline
• Isotonic Saline

Intervention

Other:
• hypertonic saline
The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution
• Saline injection
The participant will be given i.d. in 0.1 mL volumes of a saline solution

Procedure:
• Blood sampling
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland
Denmark	AAlborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA expression over time	Plasma miRNA evaluation	Before injection
Primary	miRNA expression over time	Plasma miRNA evaluation	30 minutes post-injection
Primary	miRNA expression over time	Plasma miRNA evaluation	3 hours post-injection
Primary	miRNA expression over time	Plasma miRNA evaluation	24 hours post-injection
Primary	Protein expression over time	Plasma protein evaluation	Before injection
Primary	Protein expression over time	Plasma protein evaluation	30 minutes post-injection
Primary	Protein expression over time	Plasma protein evaluation	3 hours post-injection
Primary	Protein expression over time	Plasma protein evaluation	24 hours post-injection
Secondary	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