Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patie… (NCT03999489) | Clinical Trial Compass
CompletedNot Applicable
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
France708 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at something called the SF-6D, which measures quality of life and health utility in people with early inflammatory low back pain — can you explain what 'health utility' means in practical terms, and why it matters for how my spondylarthritis care might be planned?
2Since this trial is already completed, would you be able to help me find out what the results showed about quality of life in people with early spondylarthritis, and whether those findings might be relevant to my situation?
3This study seems to focus on measuring and understanding the disease rather than testing a treatment — does that mean its main value is in improving how doctors assess patients like me, and how might that affect the tools or questionnaires used in my own care?
4Given that this was an observational study about psychometric properties rather than a drug or therapy trial, are there related treatment trials for early spondylarthritis that might be worth exploring alongside this research?
5Because the study focused on patients with early inflammatory low back pain, how would you determine whether my symptoms are at a stage where the kind of quality-of-life tracking this study examined would be useful for monitoring my condition over time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.