search
Back to results

Referral Recommendations for Axial Spondyloarthritis

Primary Purpose

Spondyloarthropathy, Ankylosing Spondylitis, Spondyloarthritis

Status
Completed
Phase
Locations
Germany
Study Type
Observational
Intervention
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Spondyloarthropathy focused on measuring pre-radiographic, screening, early diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 2, 2006
Last Updated
February 12, 2013
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT00383617
Brief Title
Referral Recommendations for Axial Spondyloarthritis
Official Title
Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
Study Type
Observational

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthropathy, Ankylosing Spondylitis, Spondyloarthritis
Keywords
pre-radiographic, screening, early diagnosis

7. Study Design

Enrollment
500 (Anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Sieper, MD
Organizational Affiliation
Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15818678
Citation
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.
Results Reference
background
PubMed Identifier
15528281
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. doi: 10.1136/ard.2004.028753. Epub 2004 Nov 4.
Results Reference
background

Learn more about this trial

Referral Recommendations for Axial Spondyloarthritis

We'll reach out to this number within 24 hrs