Catastrophism in Chronic Inflammatory Rheumatism

NCT ID: NCT04174092

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 533 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-27
• Study Completion Date: 2022-12-17

Brief Summary

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.

Conditions

Chronic Inflammatory Rheumatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

completing self-questionnaires

Intervention Type: OTHER

completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism

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

Group Type: EXPERIMENTAL

completing self-questionnaires

Intervention Type: OTHER

completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism

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

Group Type: EXPERIMENTAL

completing self-questionnaires

Intervention Type: OTHER

completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism

Interventions

completing self-questionnaires

completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anissa MEGZARI

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de Montpellier

Montpellier, , France

CHU de Nîmes

Nîmes, , France

Countries

France

Other Identifiers

2019.A01715-52

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL 2019/CGV/01

Identifier Type: -

Identifier Source: org_study_id