Pain, AcuteNCT04787198
Investigating Composite Biomarkers for Pain Catastrophizing
A study testing hypertonic saline and isotonic saline in people with Pain, Acute, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- hypertonic saline and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2022to 31 Dec 2025
- 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.)
- Focal and generalized seizure
- Surgery or any other therapy for epilepsy
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Aalborg, 9220
Silvia Lo Vecchio, +4521397785, slv@hst.aau.dk
About this study
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.
- Conditions
- Pain, Acute
- Being tested
- hypertonic saline, isotonic saline
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic salineDrug
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 .
isotonic salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline | Experimental | Not described Receives: Drug: hypertonic saline |
| isotonic saline | Placebo comparator | Not described Receives: Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: time 0 (baseline)
Metabolome analysis
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: time 4 (72 hours)
Secondary outcomes (1)
Measuring Pain using VAS
The subject will rate the pain intensity continuously for 20 minutes and VAS will start from zero (0), representing no pain, and will end at one hundred (100) representing worst pain imaginable.
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 posted8 Mar 2021
- Study start15 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Petrini, Aalborg University
- Investigators
- Laura Petrini, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787198
- Sponsor's protocol ID
- N-20200095
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Composite Biomarkers for Pain Catastrophizing
- ClinicalTrials.gov ID
- NCT04787198
- Acronym / sponsor ID
- N-20200095
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic saline | Experimental | Drug: hypertonic saline |
| isotonic saline | Placebo comparator | Drug: isotonic saline |
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 (13 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.)
- Focal and generalized seizure
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 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 . | Drug | hypertonic saline |
| isotonic salineThe 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. | Drug | isotonic saline |
Primary outcome
Oscillations of the main electroencephalogram (EEG) frequency
Time frame: 10 minutes of recording before 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.
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 before 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.
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 0 (baseline)
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.
Collection of blood samples
Time frame: Time 1 (3 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.
Collection of blood samples
Time frame: time 2 (24 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.
Collection of blood samples
Time frame: time 3 (48 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.
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.
MicroRNAs (miRNAs) expression analysis
Time frame: time 0 (baseline)
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.
MicroRNAs (miRNAs) expression analysis
Time frame: time 1 (3 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.
MicroRNAs (miRNAs) expression analysis
Time frame: time 2 (24 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.
MicroRNAs (miRNAs) expression analysis
Time frame: time 3 (48 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.
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.
Proteome analysis
Time frame: time 0 (baseline)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
Proteome analysis
Time frame: time 1(3 hours)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
Proteome analysis
Time frame: time 2 (24 hours)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
Proteome analysis
Time frame: time 3 (48 hours)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
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.
Metabolome analysis
Time frame: time 0 (baseline)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Metabolome analysis
Time frame: time 1(3 hours)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Metabolome analysis
Time frame: time 2 (24 hours)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Metabolome analysis
Time frame: time 3 (48 hours)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
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).
Plasma cortisol levels measurements
Time frame: time 1(3 hours)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma cortisol levels measurements
Time frame: time 2 (24 hours)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma cortisol levels measurements
Time frame: time 3 (48 hours)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
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 1(3 hours)
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 2 (24 hours)
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 3 (48 hours)
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).
1 secondary outcome
Measuring Pain using VAS
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Laura Petrini, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic saline and isotonic saline in people with Pain, Acute, run by Aalborg University at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Petrini, PhD (0045 99409826, lap@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillations of the main electroencephalogram (EEG) frequency (time frame: 10 minutes of recording before isotonic/hypertonic injection). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.