Referral Recommendations for Axial Spondyloarthritis

Ankylosing Spondylitis Clinical Trial

Official title:

Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383617
• Other study ID #: Antragsnummer : EA4/058/05
• Status: Completed
• Phase: N/A
• First received: October 2, 2006
• Last updated: February 12, 2013
• Start date: July 2004

Study information

• Verified date: February 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylarthropathies
• Spondylitis
• Spondylitis, Ankylosing
• Spondyloarthritis
• Spondyloarthropathy

Locations

Country	Name	City	State
Germany	Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Review. — View Citation

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. Epub 2004 Nov 4. Review. — View Citation