Referral Recommendations for Axial Spondyloarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383617
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany

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.

Condition or disease
Spondyloarthropathy Ankylosing Spondylitis Spondyloarthritis

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Official Title: Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
Study Start Date : July 2004
Actual Primary Completion Date : April 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383617

Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Joachim Sieper, MD Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany

Responsible Party: J. Sieper, Prof., Charite University, Berlin, Germany Identifier: NCT00383617     History of Changes
Other Study ID Numbers: Antragsnummer : EA4/058/05
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by J. Sieper, Charite University, Berlin, Germany:
early diagnosis

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases