Diagnostic accuracy of recently proposed criteria for inflammatory back pain (IBP) in suspected ankylosing spondylitis (AS) and early axial spondyloarthritis (axial SpA)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN66488490
• Date of registration: 19/08/2008
• Prospective Registration: Yes
• Primary sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
• Public title: Diagnostic accuracy of recently proposed criteria for inflammatory back pain (IBP) in suspected ankylosing spondylitis (AS) and early axial spondyloarthritis (axial SpA)
• Date of first enrolment: 01/09/2008
• Target sample size: 550
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66488490
• Study type: Observational
• Study design: Observational diagnostic accuracy study (Diagnostic)

Countries of recruitment

Germany

Contacts

• Name: Martin Rudwaleit

Key inclusion & exclusion criteria

Inclusion criteria: Patients (aged greater tha 18 years, either sex) with chronic back pain (greater than 3 months) of unknown origin:
1. Referred to the rheumatologist because of suspected AS/axial SpA
2. Seen by primary care physicians/orthopaedists, who agree to subsequently be referred to the rheumatologists
Exclusion criteria: Patients with a definite diagnosis (cause) related to their back pain.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing spondylitis (AS), early axial spondyloarthritis (axial SpA)
Musculoskeletal Diseases
Ankylosing spondylitis

Intervention(s)

Experimental group (no medical intervention):
The diagnostic accuracy of IBP will be investigated in four private practices and two hospitals by assessing IBP by an independent and blinded observer (rheumatologist in each setting) in patients with undiagnosed chronic back pain who are referred because of suspected SpA.

IBP will also be assessed by primary care physicians or orthopaedists in patients with chronic back pain of unclear origin, and also self-assessed by the patient prior to referral to the Rheumatology Department at Charité CBF for further work-up.

The total duration of the trial is two years. There is no follow-up.

Primary Outcome(s)

Sensitivity, specificity and positive likelihood-ratio (LR+) if two out of four parameters of IBP are present.

Secondary Outcome(s)

Sensitivity, specificity and positive likelihood-ratio (LR+) if three or four out of four parameters of IBP are present.

Secondary ID(s)

N/A

Source(s) of Monetary Support

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)