Somatosensory Phenotyping of ADPKD
- Conditions
- ADPKDPain
- Registration Number
- NCT06970028
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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 three questionnaires regarding pain and quality of life. These results will be compared with the somatosensory profile of matched healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST) Interval of ≤ 3 months between screening and study visit 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 Interval of ≤ 3 months between screening and study visit (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 domainDescribing neuropathic pain in ADPKD using the DN4 questionnaire Interval of ≤ 3 months between screening and study visit 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 Interval of ≤ 3 months between screening and study visit 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 Outcome Measures
Name Time Method Differences in somatosensory phenotype depending on the sex of patients with ADPKD Interval of ≤ 3 months between screening and study visit 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 Interval of ≤ 3 months between screening and study visit. Potential differences in pain and quality of life, described using questionnaires, of female and male patients with ADPKD will be evaluated using statistical analyses.
Correlation between QST and questionnaires Interval of ≤ 3 months between screening and study visit 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 Interval of ≤ 3 months between screening and study visit Potential differences in somatosensory phenotype depending on the disease stage of patients with ADPKD (stage 1-5) will be evaluated using statistical analyses.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium