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

Spondylarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999489
• Other study ID #: LOCAL/2013/CGV-01
• Status: Completed
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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) .

Related Conditions & MeSH terms

• Spondylarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of utility measured by the SF-6D	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.	baseline (0 months)
Primary	Level of utility measured by the SF-6D	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.	6 months
Primary	Level of utility measured by the SF-6D	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.	12 months