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Completed
NCT03999489
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
Conditions: Spondylarthritis
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Enrollment: 708
Sponsor: Centre Hospitalier Universitaire de Nīmes
Location: CHU de Nîmes Nîmes Gard
Summary
The general main objective of our study is to investigate the psychometric properties, the levels and determinants of the extent of SF- 6D utility in patients followed for recent back pain inflammatory disease.
The specific objectives are :
* Study the feasibility of the tool considering missing data, distribution, construct validity, reproducibility, sensitivity to change or clinically different groups (discriminative ability) the extent of SF -6D utility .
* Study the impact of socio-demographic characteristics, disease characteristics and quality of life, comorbidities at baseline on the measurement of utility and sensitivity to change.
Eligibility Criteria
Inclusion Criteria:
* The patient should be given free and informed consent and signed the consent
* The patient must be affiliated or beneficiary of a health insurance plan
* patients aged 18 years and under 50
* inflammatory back pain (buttocks , lumbar or thoracic spine )
* fulfilling the criteria of Calin or Berlin (30,31)
* duration of symptoms than three months and less than three years
* symptoms suggestive of spondyloarthritis as assessed by the local investigator ( score≥5 on a numerical scale from 0 to 10 where 0 = no evocative and 10 = very suggestive of spondyloarthritis ) .
Exclusion Criteria:
* Another clearly defined spinal disease (eg discarthrose )
* history of treatment with biotherapy
* taking glucocorticoids allowed only in low dose of less than 10mg of prednisone daily and stable for at least four weeks before inclusion
* Current or history anomalies that could interfere with the validity of informed consent and / or prevent a patient's optimal adhesion to the cohort (eg , alcoholism , mental illness) .
Source: ClinicalTrials.gov (NCT03999489). StuddyBuddy aggregates publicly available trial information.