The Use of QST to Characterize Somatosensory Functionality

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Quantitative Sensory Testing

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; Healthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters.	Other: Quantitative Sensory Testing; Performing QST on the dominant hand, right forearm, right flank and lower back.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Interval of 7 - 21 days between both periods

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jan de Hoon, MD, PhD, MSc, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S69194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No