Somatosensory Phenotyping of ADPKD

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06970028
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Quantitative Sensory Testing — OTHER
    We will perform QST on the dominant hand and lower back.
  • Questionnaires regarding pain and quality of life — OTHER
    Questionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life.

Study Details

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.

Key Dates

Start date
Sep 9, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST) [ Time Frame: Interval of ≤ 3 months between screening and study visit ]

Central Contacts

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