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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Maasstad Hospital
Sponsor:
Information provided by (Responsible Party):
A.E.A.M. Weel, Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01944163
First received: September 6, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.

Condition Intervention
Chronic Low Back Pain
Axial Spondyloarthritis
Other: Applying a referral model

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain - a Cluster Randomized Trial

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured by EQ-5D and healthcare use questionnaires

  • Pain and fatigue caused by the chronic low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured by the VAS-pain and VAS-fatigue

  • Referral to rheumatologist and diagnosis of axSpA [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: September 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944163

Contacts
Contact: Angelique Weel, MD/PhD 0031102912205 weela@maasstadziekenhuis.nl

Locations
Netherlands
Maasstad Hospital Not yet recruiting
Rotterdam, Netherlands
Contact: Angelique Weel, MD/PhD    0031102912205    weela@maasstadziekenhuis.nl   
Principal Investigator: Angelique Weel, MD/PhD         
Sponsors and Collaborators
Maasstad Hospital
Investigators
Principal Investigator: Angelique Weel, MD, PhD Maasstad Hospital
  More Information

No publications provided

Responsible Party: A.E.A.M. Weel, Dr., Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01944163     History of Changes
Other Study ID Numbers: impact-001, 2013-003838-32
Study First Received: September 6, 2013
Last Updated: August 25, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maasstad Hospital:
Low back pain
Impact analysis
Cluster randomized trial
Referral rule
Axial spondyloarthritis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Spondylarthritis
Spondylitis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infection

ClinicalTrials.gov processed this record on August 28, 2014