Chronic Low Back PainIMPACTNCT01944163
The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
A study testing Applying a referral model in people with Chronic Low Back Pain and Axial Spondyloarthritis, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Low Back Pain, Axial Spondyloarthritis
- What is being tested?
- Applying a referral model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Nov 2017
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- A cause for the back pain (like trauma, hernia nuclei pulposi, malignancy, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain - a Cluster Randomized Trial
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.
Read more
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.
- Conditions
- Chronic Low Back Pain, Axial Spondyloarthritis
- Being tested
- Applying a referral model
- Keywords
- Low back pain, Impact analysis, Cluster randomized trial, Referral rule, Axial spondyloarthritis
- Medical subject headings
- Axial Spondyloarthritis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying a referral modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | GP provide care as usual to their CLBP patients. |
| Referral arm | Other | 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. Receives: Other: Applying a referral model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months after enrollement
Secondary outcomes (4)
Quality of life measurements
Measured: 2 years
Cost-effectiveness
Measured by EQ-5D and healthcare use questionnaires
Measured: 2 years
Pain and fatigue caused by the chronic low back pain
Measured by the VAS-pain and VAS-fatigue
Measured: 2 years
Referral to rheumatologist and diagnosis of axSpA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2014
- Primary completionMar 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.E.A.M. Weel, Maasstad Hospital
- Investigators
- Angelique Weel, MD, PhD, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944163
- Sponsor's protocol ID
- impact-001
- Other IDs
- 2013-003838-32
- Acronym
- IMPACT
- Status last verified
- Nov 2015
- First submitted
- 6 Sep 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31990912van 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.
PubMed 27405752
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain - a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01944163
- Acronym / sponsor ID
- IMPACT / impact-001
- Conditions
- Chronic Low Back Pain, Axial Spondyloarthritis
- Keywords
- Low back pain, Impact analysis, Cluster randomized trial, Referral rule, Axial spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 17 Sep 2013 (estimated)
- 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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –GP provide care as usual to their CLBP patients. |
| Referral arm | Other | Other: Applying a referral modelGP 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- A cause for the back pain (like trauma, hernia nuclei pulposi, malignancy, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applying a referral modelGP 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. | Other | Referral arm |
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.
Time frame: 4 months after enrollement
4 secondary outcomes
Quality of life measurements
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Pain and fatigue caused by the chronic low back pain
Time frame: 2 years
Referral to rheumatologist and diagnosis of axSpA
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Derived from this study: PubMed 31990912Jamal 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.
- Derived from this study: PubMed 27405752van 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.
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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.
Angelique Weel, MD, PhD principal investigator
Maasstad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying a referral model in people with Chronic Low Back Pain and Axial Spondyloarthritis, run by Maasstad Hospital at 1 site in Netherlands.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. 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 Netherlands. 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?
Results are not available in the source record.
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?
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. (time frame: 4 months after enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944163, which also lists 2 linked publications.
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 24 Nov 2015.