The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain (IMPACT)

November 23, 2015 updated by: A.E.A.M. Weel, Maasstad Hospital

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
GP provide care as usual to their CLBP patients.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 months after enrollement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measurements
Time Frame: 2 years
2 years
Cost-effectiveness
Time Frame: 2 years
Measured by EQ-5D and healthcare use questionnaires
2 years
Pain and fatigue caused by the chronic low back pain
Time Frame: 2 years
Measured by the VAS-pain and VAS-fatigue
2 years
Referral to rheumatologist and diagnosis of axSpA
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maasstad Hospital

Investigators

  • Principal Investigator: Angelique Weel, MD, PhD, Maasstad Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT-001
  • 2013-003838-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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