The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
NCT ID: NCT01944163
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
850 participants
INTERVENTIONAL
2014-09-30
2017-11-30
Brief Summary
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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 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 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 socioeconomic 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Usual care
GP provide care as usual to their CLBP patients.
No interventions assigned to this group
Referral arm
GP are randomized in clusters 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.
Applying a referral model
GP are randomized in clusters 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.
Interventions
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Applying a referral model
GP are randomized in clusters 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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
ALL
No
Sponsors
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Maasstad Hospital
OTHER
Responsible Party
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A.E.A.M. Weel
Dr.
Principal Investigators
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Angelique Weel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maasstad Hospital
Locations
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Maasstad Hospital
Rotterdam, , Netherlands
Countries
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References
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Jamal M, Korver AM, Kuijper M, Lopes Barreto D, Appels CWY, Spoorenberg APL, Koes BW, Hazes JMW, Hoeven LV, Weel AEAM. The IMPACT study: A clustered randomized controlled trial to assess the effect of a referral algorithm for axial spondyloarthritis. PLoS One. 2020 Jan 28;15(1):e0227025. doi: 10.1371/journal.pone.0227025. eCollection 2020.
van Hoeven L, Vergouwe Y, Koes BW, Hazes JM, Weel AE. Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study. BMC Musculoskelet Disord. 2016 Jul 12;17:278. doi: 10.1186/s12891-016-1132-6.
Other Identifiers
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2013-003838-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
impact-001
Identifier Type: -
Identifier Source: org_study_id