Pain Evaluation in Rheumatoid Arthritis

Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01706029

Acronym

Douleur-PR

Enrollment

300

Registered

2012-10-15

Start date

2012-10-31

Completion date

2017-12-12

Last updated

2019-01-11

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

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Correlation	At day 1	Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire

Countries

France

Outcome results