Referral Recommendations for Axial Spondyloarthritis

NCT ID: NCT00383617

Last Updated: 2013-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31

Brief Summary

The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.

Detailed Description

Ankylosing spondylitis (AS) and its early form accounts for up to 5% of all patients with chronic back pain. Shortening the delay of 5-10 years between first symptoms and making a diagnosis of AS has become a challenge especially because effective treatments have become available. Easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier.

Methods: Orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration >3 months) and ii) onset of back pain at an age < 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (IBP), 2) positive HLA-B27, 3) sacroiliitis as detected by imaging. The final diagnosis was made according to expert opinion.

It was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial SpA.

Conditions

Spondyloarthropathy; Ankylosing Spondylitis; Spondyloarthritis

Eligibility Criteria

Inclusion Criteria

• chronic back pain with a duration of more than 3 months
• onset of back pain before age of 45 years

Exclusion Criteria

• age younger than 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

J. Sieper

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Sieper, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany

Locations

Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30

Berlin, State of Berlin, Germany

Countries

Germany

References

Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005 Apr;52(4):1000-8. doi: 10.1002/art.20990. No abstract available.

Reference Type: BACKGROUND

PMID: 15818678 (View on PubMed)

Sieper J, Rudwaleit M. Early referral recommendations for ankylosing spondylitis (including pre-radiographic and radiographic forms) in primary care. Ann Rheum Dis. 2005 May;64(5):659-63. doi: 10.1136/ard.2004.028753. Epub 2004 Nov 4.

Reference Type: BACKGROUND

PMID: 15528281 (View on PubMed)

Other Identifiers

Antragsnummer : EA4/058/05

Identifier Type: -

Identifier Source: org_study_id