PainNCT06439004
The Use of QST to Characterize Somatosensory Functionality
A study testing Quantitative Sensory Testing in people with Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Quantitative Sensory Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2024to 20 Nov 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary written informed consent has been obtained prior to any screening procedures.
- Subject is ≥ 18 years and ≤ 25 years of age.
- Subject is a non-smoker for at least 6 months before the start of the study.
- Subject has a body mass index (BMI) between 18-30 kg/m².
- Subject is in good general health, based on medical history and vital signs.
Who cannot join
- Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality.
- Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments.
- Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse.
- Subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit.
- Subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results.
- Subject is in a situation or has a condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.
- Female subject who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and is not using an adequate contraceptive method.
- Subject is participating in another trial which, in the investigator's opinion, might confound the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Quantitative Sensory Testing to Characterize Somatosensory Functionality
Pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. This set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated Aδ and unmyelinated C), as well as large fibers (thickly myelinated Aβ). In this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected.
In this study, the inter-period reproducibility of thirteen QST parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers.
- Conditions
- Pain
- Being tested
- Quantitative Sensory Testing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingOther
Performing QST on the dominant hand, right forearm, right flank and lower back.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters. Receives: Other: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-period reproducibility of QST
Inter-period reproducibility of thirteen different QST parameters on the dominant hand, right forearm, right flank and lower back of healthy volunteers.
Measured: Interval of 7 - 21 days between both periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start12 Sep 2024
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan de Hoon, MD, PhD, MSc, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439004
- Sponsor's protocol ID
- S69194
- Status last verified
- Sep 2024
- First submitted
- 27 May 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Quantitative Sensory Testing to Characterize Somatosensory Functionality
- ClinicalTrials.gov ID
- NCT06439004
- Acronym / sponsor ID
- S69194
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 3 Jun 2024 (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 has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. This set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated Aδ and unmyelinated C), as well as large fibers (thickly myelinated Aβ). In this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected.
In this study, the inter-period reproducibility of thirteen QST parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Quantitative Sensory TestingHealthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntary written informed consent has been obtained prior to any screening procedures.
- Subject is ≥ 18 years and ≤ 25 years of age.
- Subject is a non-smoker for at least 6 months before the start of the study.
- Subject has a body mass index (BMI) between 18-30 kg/m².
- Subject is in good general health, based on medical history and vital signs.
Key exclusion criteria (8 listed)
- Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality.
- Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments.
- Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse.
- Subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit.
- Subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results.
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 |
|---|---|---|
| Quantitative Sensory TestingPerforming QST on the dominant hand, right forearm, right flank and lower back. | Other | Healthy volunteers |
Primary outcome
Inter-period reproducibility of QST
Time frame: Interval of 7 - 21 days between both periods
Inter-period reproducibility of thirteen different QST parameters on the dominant hand, right forearm, right flank and lower back of healthy volunteers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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.
Jan de Hoon, MD, PhD, MSc principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Testing in people with Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 20 Dec 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 Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-period reproducibility of QST (time frame: Interval of 7 - 21 days between both periods). 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 20 Dec 2024.