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

Completed

• Conditions: Spondylarthritis

• Registration Number: NCT03999489
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-09-12
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 708

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) .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of utility measured by the SF-6D	12 months	The SF-6D derives from 11 questions of the SF36 using the algorithm of Brazier et al which then provides a unique score. It has 6 dimensions: Physical Function, Role Limitation, Social Function, Pain, Mental Health and Vitality with 4 to 6 levels of responses depending on the dimension. SF-6D thus makes it possible to describe 18,000 health conditions. The utility score obtained with SF-6D varies between 0.29 and 1.