The Use of QST to Characterize Somatosensory Functionality

NCT ID: NCT06439004

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2024-11-20

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Healthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters.

Group Type: EXPERIMENTAL

Quantitative Sensory Testing

Intervention Type: OTHER

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

Interventions

Quantitative Sensory Testing

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan de Hoon, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S69194

Identifier Type: -

Identifier Source: org_study_id