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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03999489
Other study ID # LOCAL/2013/CGV-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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) .

Study Design


Related Conditions & MeSH terms


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
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