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

• Sponsor: Aalborg University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04439994
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 19.9
• Patients Per Site: 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Hypertonic Saline; Isotonic Saline	Other: hypertonic saline; Other: Saline injection; Procedure: Blood sampling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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)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)
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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.	Other: 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

Outcome Measures

Primary Outcome Measures

1. miRNA expression over time [Before injection]

   Plasma miRNA evaluation

2. miRNA expression over time [30 minutes post-injection]

   Plasma miRNA evaluation

3. miRNA expression over time [3 hours post-injection]

   Plasma miRNA evaluation

4. miRNA expression over time [24 hours post-injection]

   Plasma miRNA evaluation

5. Protein expression over time [Before injection]

   Plasma protein evaluation

6. Protein expression over time [30 minutes post-injection]

   Plasma protein evaluation

7. Protein expression over time [3 hours post-injection]

   Plasma protein evaluation

8. Protein expression over time [24 hours post-injection]

   Plasma protein evaluation

Secondary Outcome Measures

1. Assessment of pain: visual analog scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University	Aalborg	Nordjylland	Denmark	92200
2	AAlborg University	Aalborg	Nordjylland	Denmark	9220

Sponsors and Collaborators

• Aalborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silvia Lo Vecchio, Assistant Professor, Aalborg University
• ClinicalTrials.gov Identifier: NCT04439994
• Other Study ID Numbers: N-20200015
• First Posted: Jun 19, 2020
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 27, 2022