Pain Evaluation in Rheumatoid Arthritis (Douleur-PR)
|ClinicalTrials.gov Identifier: NCT01706029|
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Limoges.
Recruitment status was: Active, not recruiting
First Posted : October 15, 2012
Last Update Posted : March 10, 2015
Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .
Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.
So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.
On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.
The aim of this study is:
- to assess the multidimensional origin of the pain in RA patients by means of questionnaires
- to look for a possible correlation between the serum level of cytokines and pain.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||September 2015|
- Evaluation of the pain [ Time Frame: At day 1 ]Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria
- Patients pain care [ Time Frame: At day 1 ]Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction
- Correlation [ Time Frame: At day 1 ]Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706029
|CHU Bordeaux- Pellegrin|
|Bordeaux, France, 33000|
|CHU Gabriel Montpied|
|Clermont-Ferrand, France, 63003|
|CHU Hôpital R. Salengro|
|Lille, France, 59037|
|Service de Rhumatologie|
|Limoges, France, 87000|
|Paris, France, 75004|
|Rouen, France, 76230|
|Strasbourg, France, 67092|
|Principal Investigator:||Pascale Vergne-Salle, MD||CHU Limoges|