NCT04439994

Brief Summary

In this experiment, the investigators would like to test the following:

  1. 1.Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
  2. 2.Can these canges correlate with the development of local hyperalgesia?
  3. 3.How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
  4. 4.Which mRNA targets are potentially affected by acute pain?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

June 16, 2020

Last Update Submit

October 2, 2023

Conditions

Hypertonic SalineIsotonic Saline

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Assessment of pain: visual analog scale

    20 minutes

Study Arms (2)

Hypertonic saline

ACTIVE COMPARATOR

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 salineProcedure: Blood sampling

Isotonic Saline

PLACEBO COMPARATOR

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.

Other: Saline injectionProcedure: Blood sampling

Interventions

hypertonic salineOTHER

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

Hypertonic saline
Saline injectionOTHER

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

Isotonic Saline
Blood samplingPROCEDURE

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

Hypertonic salineIsotonic Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women in the age 18-80 years
  • Speak and understand English

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg University

Aalborg, North Denmark, 92200, Denmark

Location

AAlborg University

Aalborg, North Denmark, 9220, Denmark

Location

Related Publications (1)

  • Giordano R, Gerra MC, Okutani H, Lo Vecchio S, Stensballe A, Petersen KK, Arendt-Nielsen L. The temporal expression of circulating microRNAs after acute experimental pain in humans. Eur J Pain. 2023 Mar;27(3):366-377. doi: 10.1002/ejp.2062. Epub 2022 Dec 9.

    PMID: 36453122DERIVED

MeSH Terms

Interventions

Saline Solution, HypertonicSodium ChlorideBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

November 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

October 3, 2023

Record last verified: 2023-10

Locations

DK(2)