Hypertonic Saline Clinical Trial
— miRNAOfficial title:
Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain
Verified date | October 2023 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Denmark | AAlborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | miRNA expression over time | Plasma miRNA evaluation | Before injection | |
Primary | miRNA expression over time | Plasma miRNA evaluation | 30 minutes post-injection | |
Primary | miRNA expression over time | Plasma miRNA evaluation | 3 hours post-injection | |
Primary | miRNA expression over time | Plasma miRNA evaluation | 24 hours post-injection | |
Primary | Protein expression over time | Plasma protein evaluation | Before injection | |
Primary | Protein expression over time | Plasma protein evaluation | 30 minutes post-injection | |
Primary | Protein expression over time | Plasma protein evaluation | 3 hours post-injection | |
Primary | Protein expression over time | Plasma protein evaluation | 24 hours post-injection | |
Secondary | 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. | 20 minutes |
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---|---|---|---|
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