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Catastrophism in Chronic Inflammatory Rheumatism (CRIC)

Primary Purpose

Chronic Inflammatory Rheumatism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
completing self-questionnaires
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Inflammatory Rheumatism focused on measuring Catastrophism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Montpellier
  • CHU de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

rheumatoid arthritis

spondyloarthritis

Psoriatic arthritis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)

Secondary Outcome Measures

Full Information

First Posted
November 19, 2019
Last Updated
March 20, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04174092
Brief Title
Catastrophism in Chronic Inflammatory Rheumatism
Acronym
CRIC
Official Title
Catastrophism in Chronic Inflammatory Rheumatism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2019 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
December 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Rheumatism
Keywords
Catastrophism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
533 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rheumatoid arthritis
Arm Type
Experimental
Arm Description
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
Arm Title
spondyloarthritis
Arm Type
Experimental
Arm Description
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
Arm Title
Psoriatic arthritis
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
completing self-questionnaires
Intervention Description
completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism
Primary Outcome Measure Information:
Title
catastrophic assessment
Description
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Time Frame
Day 0
Title
catastrophic assessment
Description
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Time Frame
at 3 months
Title
catastrophic assessment
Description
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Time Frame
at 6 months
Title
catastrophic assessment
Description
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Catastrophism in Chronic Inflammatory Rheumatism

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