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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04174092
Other study ID # LOCAL 2019/CGV/01
Secondary ID 2019.A01715-52
Status Completed
Phase N/A
First received
Last updated
Start date October 27, 2019
Est. completion date December 17, 2022

Study information

Verified date March 2023
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 533
Est. completion date December 17, 2022
Est. primary completion date December 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France CHU de Montpellier Montpellier
France CHU de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary catastrophic assessment Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism) Day 0
Primary catastrophic assessment Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism) at 3 months
Primary catastrophic assessment Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism) at 6 months
Primary catastrophic assessment Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism) at 12 months
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