Catastrophism in Chronic Inflammatory Rheumatism (CRIC)

Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).

Recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.

In chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Rheumatism
• Intervention / Treatment: Other: completing self-questionnaires

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34 295
    • CHU de Montpellier
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Major patients, hospital follow-up, with RA according to ACR 2010 criteria, or spondyloarthritis according to ASAS 2009 criteria or according to AMOR or psoriatic arthritis according to Caspar 2006 criteria.
• Patient who has given free and informed consent.
• Patient who has signed the consent form.
• Patient affiliated or benefiting from a health insurance plan.
• Adult patient (≥18 years old).

Exclusion Criteria:

• Patient under the protection of justice, under guardianship or curatorship.
• Patient unable to express consent.
• Patient for whom it is impossible to provide informed information.
• Poor command and understanding of the French language making it impossible to complete self-questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rheumatoid arthritis; Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (RAID, RAPID-3) Patients will be seen at 3, 6 and 12 months	Other: completing self-questionnaires; completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism
Experimental: spondyloarthritis; Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (BASDAI, BASFI). Patients will be seen at 3, 6 and 12 months	Other: completing self-questionnaires; completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism
Experimental: Psoriatic arthritis; Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (BASDAI, BASFI). Patients will be seen at 3, 6 and 12 months	Other: completing self-questionnaires; completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catastrophic assessment	Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)	Day 0
catastrophic assessment	Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)	at 3 months
catastrophic assessment	Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)	at 6 months
catastrophic assessment	Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)	at 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2019
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): December 17, 2022

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Catastrophism
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever
• Other Study ID Numbers: LOCAL 2019/CGV/01; 2019.A01715-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No