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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ADPKD | Patients with ADPKD will be included (≥ 12 years old). The somatosensory profile will be described using Quantitative Sensory Testing and questionnaires regarding pain and quality of life. |
| |
| Healthy volunteers | Healthy volunteers will be included (≥ 12 years old), matched with the patient group based on age, sex and BMI. The somatosensory profile will be described using Quantitative Sensory Testing and the BPI-SF questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Sensory Testing | Other | We will perform QST on the dominant hand and lower back. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Interval of ≤ 3 months between screening and study visit |
| 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 | Interval of ≤ 3 months between screening and study visit |
| 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) | Interval of ≤ 3 months between screening and study visit |
| 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 | Interval of ≤ 3 months between screening and study visit |
| Comparing pain between patients with ADPKD and healthy volunteers using the BPI-SF questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between QST and questionnaires | A correlation between QST results and results from the questionnaires will be assessed in patients with ADPKD. | Interval of ≤ 3 months between screening and study visit |
| Differences in somatosensory phenotype depending on the disease stage of ADPKD |
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Inclusion Criteria:
Patients with ADPKD
Healthy volunteers
Exclusion Criteria:
Patients with ADPKD
Healthy volunteers
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flore Van Olmen, MSc | Contact | +32 016 34 22 01 | flore.vanolmen@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Jan de Hoon, MD, PhD, MSc | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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| Questionnaires regarding pain and quality of life | Other | Questionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life. |
|
The BPI-SF questionnaire consists of 9 questions, concerning both the intensity and impact of pain on daily functioning in the last 24 hours. This questionnaire will be conducted in patients with ADPKD and healthy volunteers.
| 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. |
| Interval of ≤ 3 months between screening and study visit |
| 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. | Interval of ≤ 3 months between screening and study visit |
| 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. | Interval of ≤ 3 months between screening and study visit |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004778 |
| Environment and Public Health |