Clinical trial NCT04787198: Investigating Composite Biomarkers for Pain Catastrophizing
Official title: Investigating Composite Biomarkers for Pain Catastrophizing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Pain is a complex, multidimensional, and subjective experience; and although, investigators use a single word "pain", to describe our perception, multiple mechanisms contribute to the generation and maintenance of pain. To help diagnosing and improving pain management, there is a need for developing tools. These tools may include measurements of substances, or biomarkers, in the blood; e.g. small molecules called microRNA and proteins. In these experiments, the investigators would like to investigate how the psychological response to stress and pain alters the impulses in the brain and the content of microRNA and proteins in the blood. The future aim is to identify patients in high risk of developing and maintaining chronic pain and to be able to treat chronic pain efficiently.


Eligibility criteria: 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.)
* Focal and generalized seizure
* Surgery or any other therapy for epilepsy
* Present or previous AEDs (anti-epileptic drugs) administration
* Present or previous use of epileptic devices (\<1 year prior the enrolment)
* 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)

Primary outcomes:
measure: Oscillations of the main electroencephalogram (EEG) frequency
timeFrame: 10 minutes of recording before isotonic/hypertonic injection
measure: Oscillations of the main electroencephalogram (EEG) frequency
timeFrame: 10 minutes of recording after isotonic/hypertonic injection
measure: Perturbation of the electroencephalogram (EEG) rhythms
timeFrame: 10 minutes of recording before isotonic/hypertonic injection
measure: Perturbation of the electroencephalogram (EEG) rhythms
timeFrame: 10 minutes of recording after isotonic/hypertonic injection
measure: Collection of blood samples
timeFrame: time 0 (baseline)
measure: Collection of blood samples
timeFrame: Time 1 (3 hours)
measure: Collection of blood samples
timeFrame: time 2 (24 hours)
measure: Collection of blood samples
timeFrame: time 3 (48 hours)
measure: Collection of blood samples
timeFrame: time 4 (72 hours)
measure: MicroRNAs (miRNAs) expression analysis
timeFrame: time 0 (baseline)
measure: MicroRNAs (miRNAs) expression analysis
timeFrame: time 1 (3 hours)
measure: MicroRNAs (miRNAs) expression analysis
timeFrame: time 2 (24 hours)
measure: MicroRNAs (miRNAs) expression analysis
timeFrame: time 3 (48 hours)
measure: MicroRNAs (miRNAs) expression analysis
timeFrame: time 4 (72 hours)
measure: Proteome analysis
timeFrame: time 0 (baseline)
measure: Proteome analysis
timeFrame: time 1(3 hours)
measure: Proteome analysis
timeFrame: time 2 (24 hours)
measure: Proteome analysis
timeFrame: time 3 (48 hours)
measure: Proteome analysis
timeFrame: time 4 (72 hours)
measure: Metabolome analysis
timeFrame: time 0 (baseline)
measure: Metabolome analysis
timeFrame: time 1(3 hours)
measure: Metabolome analysis
timeFrame: time 2 (24 hours)
measure: Metabolome analysis
timeFrame: time 3 (48 hours)
measure: Metabolome analysis
timeFrame: time 4 (72 hours)
measure: Plasma cortisol levels measurement
timeFrame: time 0 (baseline)
measure: Plasma cortisol levels measurements
timeFrame: time 1(3 hours)
measure: Plasma cortisol levels measurements
timeFrame: time 2 (24 hours)
measure: Plasma cortisol levels measurements
timeFrame: time 3 (48 hours)
measure: Plasma cortisol levels measurements
timeFrame: time 4 (72 hours)
measure: Plasma Interleukin-6 (IL-6) levels measurements
timeFrame: time 0 (baseline)
measure: Plasma Interleukin-6 levels measurements
timeFrame: time 1(3 hours)
measure: Plasma Interleukin-6 levels measurements
timeFrame: time 2 (24 hours)
measure: Plasma Interleukin-6 levels measurements
timeFrame: time 3 (48 hours)
measure: Plasma Interleukin-6 levels measurements
timeFrame: time 4 (72 hours)
Secondary outcomes:
measure: Measuring Pain using VAS
timeFrame: 20 minutes
Other outcomes:
measure: Pain Catastrophizing Scale (PCS) questionnaire
timeFrame: time 0 (baseline)
measure: Positive and Negative Affect Schedule (PANAS) questionnaire
timeFrame: time 0 (baseline)
measure: Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
timeFrame: time 0 (baseline)
measure: State-Trait Anxiety Inventory - Form Y (STAI-Y)
timeFrame: time 0 (baseline)
measure: Heart rate assessment
timeFrame: time 0 (baseline)
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Laura Petrini, PhD
role: PRINCIPAL_INVESTIGATOR
References: