The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
Unknown statusNot applicableNCT01944163
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Rationale: Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting up to 24% of young chronic low back pain (CLBP) patients. For general practitioners (GPs) it is difficult to distinguish axSpA patients in the large amount of CLBP patients. In previous studies 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. Objective: To evaluate the clinical impact of a referral rule in young patients presenting at the general practitioners with chronic low back pain, who are at risk for axSpA, compared to usual care. Study design: A cluster randomized clinical trial. Study population: Primary care patients with chronic low back pain, aged 18-45 years. Intervention (if applicable): GPs are randomized in clusters either to use directly the referral rule or use the referral rule after 4 months. The referral rule consists out of four variables, a positive ASAS inflammatory back pain questionnaire, a positive family history for spondyloarthritis, a good reaction to NSAIDs (non-steroidal anti-inflammatory drugs) 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. Main study parameters/endpoints: 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. Secondary parameters: Quality of life measurements, cost-effectiveness, pain and fatigue and referral to rheumatologist and diagnosis of axSpA. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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…
Study details
- Official title
- The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain - a Cluster Randomized Trial
- Conditions
- Chronic Low Back Pain
- Axial Spondyloarthritis
- Interventions
- Other: Applying a referral model
- Sponsor
- Maasstad Hospital
- Start date
- 2014-09
- Primary completion
- 2016-03
- Sex
- All
- Age range
- from 18 Years to 45 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged 18-45 years * Coded by the GP with ICPC L03, standing for 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01944163