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Completed

NCT Number: NCT04439994

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

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?

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Key information

Conditions

Hypertonic Saline Isotonic Saline

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AAlborg University, Aalborg, North Denmark, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

hypertonic saline

Other

The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution

Saline injection

Other

The participant will be given i.d. in 0.1 mL volumes of a saline solution

blood sampling

Procedure

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

Primary outcomes

  1. miRNA expression over time

    Time frame: Before injection

    Plasma miRNA evaluation

  2. miRNA expression over time

    Time frame: 30 minutes post-injection

    Plasma miRNA evaluation

  3. miRNA expression over time

    Time frame: 3 hours post-injection

    Plasma miRNA evaluation

  4. miRNA expression over time

    Time frame: 24 hours post-injection

    Plasma miRNA evaluation

  5. Protein expression over time

    Time frame: Before injection

    Plasma protein evaluation

  6. Protein expression over time

    Time frame: 30 minutes post-injection

    Plasma protein evaluation

  7. Protein expression over time

    Time frame: 3 hours post-injection

    Plasma protein evaluation

  8. Protein expression over time

    Time frame: 24 hours post-injection

    Plasma protein evaluation

Secondary outcomes

  1. Assessment of pain: visual analog scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Acronym: miRNA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 19, 2020
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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