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

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

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?

Study Overview

• Status: Completed
• Conditions: Isotonic Saline; Hypertonic Saline
• Intervention / Treatment: Other: hypertonic saline; Procedure: Blood sampling; Other: Saline injection

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9220
      • Aalborg University
    • Aalborg, Nordjylland, Denmark, 92200
      • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: hypertonic saline; The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution; Procedure: Blood sampling; Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
Placebo Comparator: Isotonic Saline; 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.	Procedure: Blood sampling; Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected; Other: Saline injection; The participant will be given i.d. in 0.1 mL volumes of a saline solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N-20200015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No