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

ISRCTN	ISRCTN66488490
DOI	https://doi.org/10.1186/ISRCTN66488490
Secondary identifying numbers	N/A

Submission date: 11/07/2008
Registration date: 19/08/2008
Last edited: 19/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Martin Rudwaleit
Scientific

Hindenburgdamm 30
Berlin
12200
Germany

Phone	+49 (0)30 8445 4547
Email	martin.rudwaleit@charite.de

Study information

Study design	Observational diagnostic accuracy study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	DIVERS
Study objectives	Sensitivity of at least 70% and specificity of at least 70% for the previously proposed criteria for inflammatory back pain (IBP).
Ethics approval(s)	Ethics approval received from the Ethics Committee of Charité - University Medicine Berlin on the 8th July 2008 (ref: EA4/058/08).
Health condition(s) or problem(s) studied	Ankylosing spondylitis (AS), early axial spondyloarthritis (axial SpA)
Intervention	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.
Intervention type	Other
Primary outcome measure	Sensitivity, specificity and positive likelihood-ratio (LR+) if two out of four parameters of IBP are present.
Secondary outcome measures	Sensitivity, specificity and positive likelihood-ratio (LR+) if three or four out of four parameters of IBP are present.
Overall study start date	01/09/2008
Completion date	01/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	550
Key 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
Key exclusion criteria	Patients with a definite diagnosis (cause) related to their back pain.
Date of first enrolment	01/09/2008
Date of final enrolment	01/08/2010

Locations

Countries of recruitment

Germany

Study participating centre

Hindenburgdamm 30

Berlin
12200
Germany

Sponsor information

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
University/education

c/o Dr. Krukenkamp
Charitéplatz 1
Virchowweg 1
Berlin
10117
Germany

Email	c.krukenkamp@charite.de
Website	http://www.charite.de/
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Research council

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan