Catastrophism in Chronic Inflammatory Rheumatism

NCT04174092 | Completed

• 2 other identifiers: LOCAL 2019/CGV/012019.A01715-52
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 2

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

Keywords

Catastrophism

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

rheumatoid arthritis

EXPERIMENTAL

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

spondyloarthritis

EXPERIMENTAL

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

Psoriatic arthritis

EXPERIMENTAL

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

Interventions

completing self-questionnaires OTHER

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

Psoriatic arthritis; rheumatoid arthritis; spondyloarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier

Montpellier, 34 295, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start: October 27, 2019
• Primary Completion: December 17, 2022
• Study Completion: December 17, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

FR (2)