Pain Evaluation in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01706029
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Primary Completion: 2014-12
• Study Completion: 2017-12-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adults with RA treated with DMARDs and/or biotherapy,
• Capable of providing written consent

Exclusion Criteria

• Patients affected by a painful disease other one than RA,
• Fibromyalgia,
• A malignancy disease,
• An hemopathy,
• Psychiatric disorders or dementia and
• Acute infectious diseases and
• Receive or had received anti-IL6 therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the pain	At day 1	Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria

Secondary Outcome Measures

Name	Time	Method
Correlation	At day 1	Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire
Patients pain care	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

Trial Locations

Locations (7)

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

CHU Bordeaux- Pellegrin; 🇫🇷 Bordeaux, France

CHU Hôpital R. Salengro; 🇫🇷 Lille, France

Service de Rhumatologie; 🇫🇷 Limoges, France

CHU Hôtel-Dieu; 🇫🇷 Paris, France

CHU Bois-Guillaume; 🇫🇷 Rouen, France

CHU Hautepierre; 🇫🇷 Strasbourg, France