- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306784
Pain Catastrophizing and Routine Assessment of Patient Index Data 3(RAPID3) in Ten Categories of Rheumatology Outpatients
September 20, 2021 updated by: Nantes University Hospital
Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic
Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including RAPID3 and pain catastrophizing scales.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology clinic from a university French hospital in at least one month period) of a set of 6 questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and related conditions.
Study Type
Observational
Enrollment (Actual)
572
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nantes, France, 44093
- CHU de Nantes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
300 Men or women coming to the Rheumatology Department of the Nantes University Hospital with a senior rheumatologist agreeing to fulfil the set of 6 questionnaires
Description
Inclusion Criteria:
- any outpatient aged 18 or more, agreeing to fulfil the set of 6 questionnaires
- Man or woman coming to the Rheumatology Department of the Nantes University Hospital with a senior rheumatologist
Exclusion Criteria:
- Patients not fluent enough in French or suffering from neurological or psychological disorders making their responses unreliable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ranking of PCS scores according to the underlying disorders (10 predefined categories), and also ranking of RAPID-3 scores according to the underlying disorders (10 predefined categories).
Time Frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
|
Composite score: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients.
|
At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ranking of correlations between RAPID3 and Pain catastrophizing scale (PCS) (13 items) scores in the 10 subsets of categories listed above (from the strongest correlation to the lowest correlation)
Time Frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
|
RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients
|
At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Marie Berthelot, Dr, CHU de Nantes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 3, 2017
Primary Completion (ACTUAL)
January 31, 2018
Study Completion (ACTUAL)
January 31, 2018
Study Registration Dates
First Submitted
July 5, 2017
First Submitted That Met QC Criteria
October 5, 2017
First Posted (ACTUAL)
October 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Arthritis
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Spinal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Arthritis, Rheumatoid
- Rheumatic Diseases
- Spondylitis
- Spondylarthritis
- Rheumatic Fever
Other Study ID Numbers
- RC17_0182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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