Investigating Composite Biomarkers for Pain Catastrophizing
Overview
- Phase
- Not Applicable
- Intervention
- hypertonic saline
- Conditions
- Pain, Acute
- Sponsor
- Aalborg University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Oscillations of the main electroencephalogram (EEG) frequency
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Laura Petrini
Associate Professor
Aalborg University
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.
Arms & Interventions
hypertonic saline
Intervention: hypertonic saline
isotonic saline
Intervention: isotonic saline
Outcomes
Primary Outcomes
Oscillations of the main electroencephalogram (EEG) frequency
Time Frame: 10 minutes of recording after isotonic/hypertonic injection
Electroencephalographic (EEG) recording will be performed placing a 64-electrodes cap over the scalp according to the 10-20 international system. Oscillations of the main EEG frequency bands (delta, alpha, beta, gamma) from the frontal and parietal lobes will be detected and correlated to the individual pain rate as well as the dimensions of the psychological questionnaires.
Perturbation of the electroencephalogram (EEG) rhythms
Time Frame: 10 minutes of recording after isotonic/hypertonic injection
Electroencephalographic (EEG) recording will be performed placing a 64-electrodes cap over the scalp according to the 10-20 international system. Perturbation of the above-mentioned EEG rhythms will be measured in response to the hypertonic/isotonic saline injection and compared to a resting state baseline recording.
Collection of blood samples
Time Frame: time 4 (72 hours)
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected into SST™ II Advance Serum Separation Tubes containing anticoagulant EDTA.
Proteome analysis
Time Frame: time 4 (72 hours)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
MicroRNAs (miRNAs) expression analysis
Time Frame: time 4 (72 hours)
From the blood samples previously collected, miRNA will be isolated for a subsequent miRNA library preparation. Subsequently, extracted miRNA will be reversely transcribed, and cDNA will be used for total miRNAs sequencing.
Plasma cortisol levels measurements
Time Frame: time 4 (72 hours)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma Interleukin-6 (IL-6) levels measurements
Time Frame: time 0 (baseline)
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma Interleukin-6 levels measurements
Time Frame: time 4 (72 hours)
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Metabolome analysis
Time Frame: time 4 (72 hours)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Plasma cortisol levels measurement
Time Frame: time 0 (baseline)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Secondary Outcomes
- Measuring Pain using VAS(20 minutes)