Chronic Inflammatory RheumatismCRICNCT04174092
Catastrophism in Chronic Inflammatory Rheumatism
A study testing completing self-questionnaires in people with Chronic Inflammatory Rheumatism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Rheumatism
- What is being tested?
- completing self-questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Oct 2019to 17 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- completing self-questionnaires
- Keywords
- Catastrophism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completing self-questionnairesOther
completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: completing self-questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Measured: Day 0
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Measured: at 3 months
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Measured: at 6 months
catastrophic assessment
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start27 Oct 2019
- Primary completion17 Dec 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory RheumatismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174092
- Sponsor's protocol ID
- LOCAL 2019/CGV/01
- Other IDs
- 2019.A01715-52
- Acronym
- CRIC
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2019
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catastrophism in Chronic Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT04174092
- Acronym / sponsor ID
- CRIC / LOCAL 2019/CGV/01
- Conditions
- Chronic Inflammatory Rheumatism
- Keywords
- Catastrophism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis | Experimental | Other: completing self-questionnairesFilling 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 |
| spondyloarthritis | Experimental | Other: completing self-questionnairesFilling 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 |
| Psoriatic arthritis | Experimental | Other: completing self-questionnairesFilling 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completing self-questionnairescompleting self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism | Other | Psoriatic arthritis, rheumatoid arthritis, spondyloarthritis |
Primary outcome
catastrophic assessment
Time frame: Day 0
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Time frame: at 3 months
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Time frame: at 6 months
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
catastrophic assessment
Time frame: at 12 months
Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing completing self-questionnaires in people with Chronic Inflammatory Rheumatism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catastrophic assessment (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.