Mapping sensory pain patterns in ADPKD
Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires
This project will test whether detailed sensory testing and short questionnaires can identify characteristic pain patterns in people aged 12 and older with ADPKD compared with matched healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06970028 on ClinicalTrials.gov |
What this trial studies
The study uses Quantitative Sensory Testing (QST) on the dominant hand and the lower back together with four questionnaires about pain and quality of life to map somatosensory profiles. Results from patients with ADPKD (age ≥12) will be compared with healthy volunteers matched for age, sex, and BMI. Key exclusions include current dialysis, prior kidney transplant, use of tolvaptan, skin problems at test sites, pregnancy or breastfeeding, and heavy alcohol or cannabis use. The aim is to better define pain mechanisms in ADPKD so future pain management and therapeutic approaches can be more targeted.
Who should consider this trial
Good fit: Ideal participants are people aged 12 or older with a confirmed ADPKD diagnosis (and matched healthy volunteers) who can attend in-person visits for sensory testing and complete pain and quality-of-life questionnaires.
Not a fit: Patients on dialysis, those with a prior kidney transplant, current tolvaptan users, those with skin conditions at the test sites, pregnant or breastfeeding individuals, or those unable to follow alcohol/cannabis restrictions may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could help clinicians match treatments to the type of pain patients have and lead to better pain relief for people with ADPKD.
How similar studies have performed: Quantitative Sensory Testing has been used successfully to characterize chronic and neuropathic pain in other conditions, but applying it specifically to ADPKD pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with ADPKD * Subject is ≥ 12 years old. * Subject is diagnosed with ADPKD. Healthy volunteers * Subject is ≥ 12 years old. * Subject is in good general health, based on medical history and vital signs. * Subject is matched to the patient group for age, sex and BMI. Exclusion Criteria: Patients with ADPKD * Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand and/or lower back which, in the investigator's opinion, might interfere with the study assessments. * Subject is currently undergoing dialysis, had a kidney transplant or is a user of tolvaptan. * Female who is pregnant or breastfeeding. * Simultaneous participation in another study which, in the investigator's opinion, might confound the results of the study. * Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, and/or consumes ≥ 3 alcoholic consumptions per day. * Subject is a regular user of cannabis, any illicit drugs and/or has a history of drug abuse. * Subject is unable to refrain from drinking caffeinated beverages (such as coffee, tea, cola,…) 24 hours prior to each study visit. * Subject has used concomitant drugs and/or treatments in a period smaller than or equal to 5 half-lives prior to enrollment, that may interfere, in the investigator's opinion, with the study results. * Subject has a history of any illness or condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study. Healthy volunteers * Subject has a history of any illness or condition which may affect the normal somatosensory functionality. * Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand and/or lower back which, in the investigator's opinion, might interfere with the study assessments. * Female who is pregnant or breast-feeding. * Simultaneous participation in another study which, in the investigator's opinion, might confound the results of the study. * Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, and/or consumes ≥ 3 alcoholic consumptions per day. * Subject is a regular user of cannabis, any illicit drugs and/or has a history of drug abuse. * Subject is unable to refrain from drinking caffeinated beverages (such as coffee, tea, cola,…) 24 hours prior to each study visit. * Subject has used concomitant drugs and/or treatments in a period smaller than or equal to 5 half-lives prior to enrollment, that may interfere, in the investigator's opinion, with the study results. * Subject has a history of any illness or condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Jan de Hoon, MD, PhD, MSc — UZ Leuven
- Study coordinator: Flore Van Olmen, MSc
- Email: flore.vanolmen@uzleuven.be
- Phone: +32 016 34 22 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.