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Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06737094
Acronym
CRAMéREIN
Enrollment
250
Registered
2024-12-17
Start date
2025-01-31
Completion date
2025-07-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease(CKD), Cramps

Keywords

Cramps, Chronic Kidney Disease, Pain

Brief summary

Cramps are a frequent and severe complication in CKD patients. Their characteristics : triggering factors, associated factors, are not well known. There is no recognized effective treatment. Using a questionnaire, the investigators wish to determine prevalence, severity and associated factors of cramps in our CKD patients. Better knowledge about cramps in CKD patients will allow to better support, and give a practical tool for treatment evaluation.

Detailed description

The investigator have elaborated a specific questionnaire for our CKD patient about cramps. This questionnaire concerns only cramps, regardless of the origin. The first question of the questionnaire will allow to evaluate the prevalence of cramps in our population of CKD patients. Every patient will indicate his medical treatment and biological datas. Only patients who will answer Yes to the first question will complete the cramp score of gravity questionnaire. This score is composed of 4 items : frequency of crisis, there impact on sleep, there duration and there intesity Patients will also indicate for how long time there have experimented cramps, the muscular zones involved, associated symptoms, triggering factors, and does something can help them for cramps (medicinal or non medicinal). The third part concerns there treatment and biological datas. Finally there will complete the QOL-SF12 questionnaire.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Voluntary patients with CKD III to V (GFR\<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis). * Non opposed to participate to the research.

Exclusion criteria

* Transplanted patient with functional graft.

Design outcomes

Primary

MeasureTime frame
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patientsDay 0 - visit of inclusion

Secondary

MeasureTime frameDescription
Frequency of pain intensityDay 0 - visit of inclusion
Identification of potential triggering factorsDay 0 - visit of inclusionthrough a questionnaire triggering factors will be identified
Measure of Severity of crampsDay 0 - visit of inclusionwith a scale
Identification of potential improving treatment (medicinal or not)Day 0 - visit of inclusionthrough a questionnaire which identified potential improving treatment
Impact on Quality Of Life through a questionnaireDay 0 - visit of inclusionimpact of cramps on their daily life
Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)Day 0 - visit of inclusion

Countries

France

Contacts

Primary ContactMarie-Alyette Costa de Beauregard, MD
marie.costadebeauregard@aphp.fr+ 33 1 42 17 72 03
Backup ContactJean-Jacques Boffa, PU-PH
jean-jacques.boffa@aphp.fr+33 (0) 1 56 01 60 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026