To evaluate the clinical impact of the CaFaSpA referral rule in young patients presenting at the general practioners with chronic low back pain, who are at risk for axSpA, compared to usual care.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a change in the Roland Morris Disability Questionnaire
(RMDQ) compared to baseline in the CLBP patients with or without use of the
referral model after 4 months.
Secondary outcome
Quality of life measurements (SF-36), cost-effectiveness (EQ-5D, iPCQ, iMCQ),
pain and fatigue (VAS), psychosocial tests (Tampa scale for kinesiofobia, Fear
avoidance beliefs questionnaire, Hospital Anxiety Depression Scale), referral
to rheumatologist and diagnosis of axSpA.
Background summary
Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting
up to 24% of young chronic low back pain (CLBP) patients. For GPs it is
difficult to distinguish axSpA patients in the large amount of CLBP patients.
In the CaFaSpA 1 and CaFaSpA 2 study a referral rule for axSpA applicable in
CLBP patients was developed and validated. The next step is to investigate the
impact of the referral rule in daily practice. This impact analysis will test
if the referral rule will be beneficial or harmful.
Study objective
To evaluate the clinical impact of the CaFaSpA referral rule in young patients
presenting at the general practioners with chronic low back pain, who are at
risk for axSpA, compared to usual care.
Study design
A cluster randomized clinical trial.
Intervention
GP are randomized either to use or not to use the CaFaSpA referral model. The
CaFaSpA referral models consists out of four variables, a positive ASAS IBP
questionnaire, a positive family history for SpA, a good reaction to NSAIDs and
back pain duration longer than 5 years. If at least two out of four variables
are present a referral to the rheumatologist is advised.
Study burden and risks
The burden and risks associated with participation are minimal. No medical
intervention is taken place. If the GP of the patients is randomized to the
referral model, the patient is checked for the risk of axial spondyloarthritis,
by the non-invasive referral model. If the referral model is positive a
referral to the rheumatologist is advised. Is the GP is randomized to the
*usual care* there is no difference in the treatment of low back pain than
nowadays. A GP is still allowed to treat the CLBP patients optimal and a
referral to the rheumatologist is allowed but not actively advised.
All participating CLBP patients are asked to fill several questionnaires at
four different time points, at baseline, after 12 months and after 24 months.
In total there are 8 questionnaires and four separate questions. The
questionnaire are designed to fill out by the patient themselves. The total
time to fill in the questionnaire is estimated to be 30 minutes.
The benefits of the study are:
- For the CLBP patients, up to 24% of the back pain complaints are caused by
axSpA, but the GPs are not (yet) aware of this disease. When a CLBP patient is
participating in this study, the chance of having axSpA as cause for the back
pain is investigated. This a benefit for a CLBP patients since there is
effective treatment for axSpA.
- For the GP it is very difficult to distinguish an axSpA patients in the large
amount of CLBP patients. If it appears that the validated CaFaSpA referral rule
has an impact on CLBP and GPs, the next step will be implementation of this
referral model in daily practice and it will become a helpful tool for the GP.
- For the society, CLBP is a great socio-economic burden for the society. When
one of the causes for CLBP, namely axSpA is diagnosed and treated in an earlier
stage this will lead to a decreased sick leave because of back pain and is
therefore potentially cost-effective.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
• Aged 18-45 years
• ICPC L03, non-specific low back pain
• > 12 weeks of low back pain
• Mentally competent
• Understanding of the Dutch language (written)
• Willing to sign informed consent
Exclusion criteria
• A cause for the back pain (like trauma, hernia nuclei pulposi, malignancy, etc)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | EudraCT number: 2013-003838-32 en NCT nummer: NCT01944163 |
| CCMO | NL45686.101.13 |