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Completed

NCT Number: NCT06439004

The Use of QST 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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative Sensory Testing

Other

Performing QST on the dominant hand, right forearm, right flank and lower back.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Use of Quantitative Sensory Testing to Characterize Somatosensory Functionality

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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