Text Size

Referral Recommendations for Axial Spondyloarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00383617
First received: October 2, 2006
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Spondyloarthropathy
Ankylosing Spondylitis
Spondyloarthritis

Study Type: Observational
Official Title: Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Estimated Enrollment: 500
Study Start Date: July 2004
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383617

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

Publications:

Responsible Party: J. Sieper, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00383617     History of Changes
Other Study ID Numbers: Antragsnummer : EA4/058/05
Study First Received: October 2, 2006
Last Updated: February 12, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
pre-radiographic
screening
early diagnosis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Spondylarthropathies
Bone Diseases, Infectious
Infection
 Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 16, 2013