Hypertonic SalinemiRNANCT04439994
Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)
A study testing hypertonic saline, Saline injection and Blood sampling in people with Hypertonic Saline and Isotonic Saline, run by Aalborg University at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertonic Saline, Isotonic Saline
- What is being tested?
- hypertonic saline, Saline injection and Blood sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women in the age 18-80 years
- Speak and understand English
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University
Aalborg, North Denmark, 92200
AAlborg University
Aalborg, North Denmark, 9220
About this study
Official title: Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain
In this experiment, the investigators would like to test the following:
- Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
- Can these canges correlate with the development of local hyperalgesia?
- How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
- Which mRNA targets are potentially affected by acute pain?
- Conditions
- Hypertonic Saline, Isotonic Saline
- Being tested
- hypertonic saline, Saline injection, Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic salineOther
The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution
Saline injectionOther
The participant will be given i.d. in 0.1 mL volumes of a saline solution
Blood samplingProcedure or surgery
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: hypertonic saline; Procedure: 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. Receives: Other: Saline injection; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression over time
Plasma miRNA evaluation
Measured: Before injection
miRNA expression over time
Plasma miRNA evaluation
Measured: 30 minutes post-injection
miRNA expression over time
Plasma miRNA evaluation
Measured: 3 hours post-injection
miRNA expression over time
Plasma miRNA evaluation
Measured: 24 hours post-injection
Protein expression over time
Plasma protein evaluation
Measured: Before injection
Protein expression over time
Plasma protein evaluation
Measured: 30 minutes post-injection
Protein expression over time
Plasma protein evaluation
Measured: 3 hours post-injection
Protein expression over time
Plasma protein evaluation
Measured: 24 hours post-injection
Secondary outcomes (1)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Nov 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertonic SalineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439994
- Sponsor's protocol ID
- N-20200015
- Acronym
- miRNA
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2020
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36453122
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain
- ClinicalTrials.gov ID
- NCT04439994
- Acronym / sponsor ID
- miRNA / N-20200015
- Conditions
- Hypertonic Saline, Isotonic Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this experiment, the investigators would like to test the following:
- Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
- Can these canges correlate with the development of local hyperalgesia?
- How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
- Which mRNA targets are potentially affected by acute pain?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline | Active comparator | Other: hypertonic saline, Procedure: Blood samplingEach 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. |
| Isotonic Saline | Placebo comparator | Other: Saline injection, Procedure: Blood samplingEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy men and women in the age 18-80 years
- Speak and understand English
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypertonic salineThe participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution | Other | Hypertonic saline |
| Saline injectionThe participant will be given i.d. in 0.1 mL volumes of a saline solution | Other | Isotonic Saline |
| Blood samplingWhole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected | Procedure or surgery | Hypertonic saline, Isotonic Saline |
Primary outcome
miRNA expression over time
Time frame: Before injection
Plasma miRNA evaluation
miRNA expression over time
Time frame: 30 minutes post-injection
Plasma miRNA evaluation
miRNA expression over time
Time frame: 3 hours post-injection
Plasma miRNA evaluation
miRNA expression over time
Time frame: 24 hours post-injection
Plasma miRNA evaluation
Protein expression over time
Time frame: Before injection
Plasma protein evaluation
Protein expression over time
Time frame: 30 minutes post-injection
Plasma protein evaluation
Protein expression over time
Time frame: 3 hours post-injection
Plasma protein evaluation
Protein expression over time
Time frame: 24 hours post-injection
Plasma protein evaluation
1 secondary outcome
Assessment of pain: visual analog scale
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 36453122Giordano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic saline, Saline injection and Blood sampling in people with Hypertonic Saline and Isotonic Saline, run by Aalborg University at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression over time (time frame: Before injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.