About this trial
Over 60% of patients with ADPKD suffer from pain, mostly in the abdomen, flank and back, often leading to the diagnosis. It is challenging to manage and cure the pain; approximately 39% of patients are not satisfied with their pain treatment, since the pain prevents them from doing various activities, affecting their quality of life. Pain can be present before enlargement of the kidneys, the source of the pain is often unknown and common analgesics are insufficient to manage the pain or cannot be taken due to renal impairment. By further investigating and characterizing the pain phenotype of the ADPKD population, pain management might be improved and alternative therapeutic approaches might be developed. In this clinical study, pain will be assessed in patients with ADPKD using Quantitative Sensory Testing (QST) on the dominant hand and the lower back, together with four questionnaires regarding pain and quality of life. These results will be compared with the somatosensory profile of matched healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is ≥ 12 years old.
Subject is diagnosed with ADPKD.
Subject is ≥ 12 years old.
Subject is in good general health, based on medical history and vital signs.
Disqualifiers
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.
Trial population
Patients with ADPKD from the University Hospitals Leuven will be included in this study. Additionally, healthy volunteers will be included using the registered database of the Center for Clinical Pharmacology (UZ Leuven).
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Quantitative Sensory Testing
Other interventionWe will perform QST on the dominant hand and lower back.
Questionnaires regarding pain and quality of life
Other interventionQuestionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life.
Treatment groups
Trial outcomes
Primary outcomes
Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST)
The somatosensory phenotype of patients with ADPKD will be evaluated using QST on the dominant hand and lower back. These results will be compared with the somatosensory phenotype of matched healthy volunteers.
Describing pain in ADPKD using the ADPKD-PDS questionnaire
(Potential) pain in the last 7 days will be assessed using the ADPKD-PDS questionnaire, which contains 20 questions (1-5 Likert scale) in 7 domains: Dull Pain Severity, Sharp Pain Severity, Discomfort Severity, Overall Pain and Discomfort Severity, Dull Pain Interference, Sharp Pain Interference, and Discomfort Interference. Unit of Measure: Total score per domain
Describing neuropathic pain in ADPKD using the DN4 questionnaire
The DN4 questionnaire will be used to evaluate whether the (potential) pain is neuropathic. The questionnaire consists of 10 yes/no questions, in which a total score of 4/10 or higher is considered indicative of neuropathic pain. Unit of Measure: Total DN4 score (/10)
Describing quality of life in ADPKD using the ADPKD-IS questionnaire
Quality of life will be assessed using the ADPKD-IS questionnaire, which consists of 18 questions (1-5 Likert scale) in 3 domains (physical, emotional, fatigue) and 4 additional elements (guilt, sleep, size/shape of abdomen, urinary frequency/urgency). Unit of Measure: Total score per domain/element
Secondary outcomes
Correlation between QST and questionnaires
A correlation between QST results and results from the questionnaires will be assessed in patients with ADPKD.
Differences in somatosensory phenotype depending on the disease stage of ADPKD
Potential differences in somatosensory phenotype depending on the disease stage of patients with ADPKD (stage 1-5) will be evaluated using statistical analyses.
Differences in somatosensory phenotype depending on the sex of patients with ADPKD
Potential differences in the somatosensory phenotype (QST) of female and male patients with ADPKD will be evaluated using statistical analyses.
Differences in pain and quality of life depending on the sex of patients with ADPKD
Potential differences in pain and quality of life, described using questionnaires, of female and male patients with ADPKD will be evaluated using statistical analyses.
Sponsors and contacts
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