Investigating Composite Biomarkers for Pain Catastrophizing
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedStudy Start
First participant enrolled
October 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 2, 2024
February 1, 2024
2.2 years
February 16, 2021
February 1, 2024
Conditions
Outcome Measures
Primary Outcomes (34)
Oscillations of the main electroencephalogram (EEG) frequency
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.
10 minutes of recording before isotonic/hypertonic injection
Oscillations of the main electroencephalogram (EEG) frequency
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.
10 minutes of recording after isotonic/hypertonic injection
Perturbation of the electroencephalogram (EEG) rhythms
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.
10 minutes of recording before isotonic/hypertonic injection
Perturbation of the electroencephalogram (EEG) rhythms
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.
10 minutes of recording after isotonic/hypertonic injection
Collection of blood samples
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.
time 0 (baseline)
Collection of blood samples
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.
Time 1 (3 hours)
Collection of blood samples
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.
time 2 (24 hours)
Collection of blood samples
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.
time 3 (48 hours)
Collection of blood samples
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.
time 4 (72 hours)
MicroRNAs (miRNAs) expression analysis
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.
time 0 (baseline)
MicroRNAs (miRNAs) expression analysis
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.
time 1 (3 hours)
MicroRNAs (miRNAs) expression analysis
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.
time 2 (24 hours)
MicroRNAs (miRNAs) expression analysis
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.
time 3 (48 hours)
MicroRNAs (miRNAs) expression analysis
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.
time 4 (72 hours)
Proteome analysis
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
time 0 (baseline)
Proteome analysis
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
time 1(3 hours)
Proteome analysis
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
time 2 (24 hours)
Proteome analysis
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
time 3 (48 hours)
Proteome analysis
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
time 4 (72 hours)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
time 0 (baseline)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
time 1(3 hours)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
time 2 (24 hours)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
time 3 (48 hours)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
time 4 (72 hours)
Plasma cortisol levels measurement
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 0 (baseline)
Plasma cortisol levels measurements
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 1(3 hours)
Plasma cortisol levels measurements
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 2 (24 hours)
Plasma cortisol levels measurements
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 3 (48 hours)
Plasma cortisol levels measurements
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 4 (72 hours)
Plasma Interleukin-6 (IL-6) levels measurements
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 0 (baseline)
Plasma Interleukin-6 levels measurements
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 1(3 hours)
Plasma Interleukin-6 levels measurements
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 2 (24 hours)
Plasma Interleukin-6 levels measurements
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 3 (48 hours)
Plasma Interleukin-6 levels measurements
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
time 4 (72 hours)
Secondary Outcomes (1)
Measuring Pain using VAS
20 minutes
Other Outcomes (5)
Pain Catastrophizing Scale (PCS) questionnaire
time 0 (baseline)
Positive and Negative Affect Schedule (PANAS) questionnaire
time 0 (baseline)
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
time 0 (baseline)
- +2 more other outcomes
Study Arms (2)
hypertonic saline
EXPERIMENTALisotonic saline
PLACEBO COMPARATORInterventions
The site of injections will be determined by palpation of the contracted First Dorsal Interosseus (FDI) muscle. The skin will be cleaned with alcohol before injection. A bolus injection of hypertonic saline (7% NaCl) will be administered to the FDI muscle using a 1 mL syringe with a disposable needle (27G), and 30 the volume of the bolus will be 0.2 mL .
The site of injections will be determined by palpation of the contracted First Dorsal Interosseus (FDI) muscle. The skin will be cleaned with alcohol before injection. A bolus injection of 0.2 mL isotonic saline (9 mg/mL) will be administered to the FDI muscle as control.
Eligibility Criteria
You may qualify if:
- Healthy men and women in the age 18-80 years
- Speak and understand English
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University
Aalborg, 9220, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Petrini, PhD
Aalborg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 16, 2021
First Posted
March 8, 2021
Study Start
October 15, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
February 2, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share