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Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Spondylarthritis

Study type

Observational

Funder types

Other

Identifiers

NCT03999489
LOCAL/2013/CGV-01

Details and patient eligibility

About

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.

Enrollment

708 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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) .

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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