The Use of QST to Characterize Somatosensory Functionality

NCT06439004 | Completed

• 1 other identifier: S69194
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

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

Other: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing OTHER

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan de Hoon, MD, PhD, MSc

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: September 12, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)