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NCT Number: NCT06737094

Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

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.

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Key information

Conditions

Cramps Chronic Disease Chronic Kidney Disease(CKD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients

    Time frame: Day 0 - visit of inclusion

Secondary outcomes

  1. Measure of Severity of cramps

    Time frame: Day 0 - visit of inclusion

    with a scale

  2. Frequency of pain intensity

    Time frame: Day 0 - visit of inclusion

  3. Identification of potential triggering factors

    Time frame: Day 0 - visit of inclusion

    through a questionnaire triggering factors will be identified

  4. Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)

    Time frame: Day 0 - visit of inclusion

  5. Identification of potential improving treatment (medicinal or not)

    Time frame: Day 0 - visit of inclusion

    through a questionnaire which identified potential improving treatment

  6. Impact on Quality Of Life through a questionnaire

    Time frame: Day 0 - visit of inclusion

    impact of cramps on their daily life

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Jacques Boffa, PU-PH

CONTACT

[email protected]

+33 (0) 1 56 01 60 29

Marie-Alyette Costa de Beauregard, MD

CONTACT

[email protected]

+ 33 1 42 17 72 03

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CRAMéREIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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