SpondylarthritisNCT03999489
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
An observational study of Spondylarthritis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Spondylarthritis
- How many people
- 708 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 708 patients with early inflammatory low back pain included in the French cohort DESIR
Who may be able to join
- 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 ) .
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spondylarthritis
- Medical subject headings
- Spondylarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (0 months)
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.
Measured: 6 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999489
- Sponsor's protocol ID
- LOCAL/2013/CGV-01
- Status last verified
- Jun 2019
- First submitted
- 12 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
- ClinicalTrials.gov ID
- NCT03999489
- Acronym / sponsor ID
- LOCAL/2013/CGV-01
- Conditions
- Spondylarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 708 patients with early inflammatory low back pain included in the French cohort DESIR
Key inclusion criteria (7 listed)
- The patient should be given free and informed consent and signed the consent
Key exclusion criteria (4 listed)
- Another clearly defined spinal disease (eg discarthrose )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of utility measured by the SF-6D
Time frame: baseline (0 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.
Level of utility measured by the SF-6D
Time frame: 6 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.
Level of utility measured by the SF-6D
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthritis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of utility measured by the SF-6D (time frame: baseline (0 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.