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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Hypertonic Saline Isotonic Saline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

hypertonic saline

Intervention Type OTHER

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

Blood sampling

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

Saline injection

Intervention Type OTHER

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

Blood sampling

Intervention Type PROCEDURE

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

Interventions

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hypertonic saline

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

Intervention Type OTHER

Saline injection

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

Intervention Type OTHER

Blood sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes