Skip to main content
Clinical Trials/NCT06439004
NCT06439004
Completed
N/A

The Use of Quantitative Sensory Testing to Characterize Somatosensory Functionality

Universitaire Ziekenhuizen KU Leuven1 site in 1 country20 target enrollmentSeptember 12, 2024
ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
20
Locations
1
Primary Endpoint
Inter-period reproducibility of QST
Status
Completed
Last Updated
last year

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
September 12, 2024
End Date
November 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials