Contact information
Type
Scientific
Contact name
Dr Martin Rudwaleit
ORCID ID
Contact details
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)30 8445 4547
martin.rudwaleit@charite.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DIVERS
Study hypothesis
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).
Study design
Observational diagnostic accuracy study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
550
Participant exclusion criteria
Patients with a definite diagnosis (cause) related to their back pain.
Recruitment start date
01/09/2008
Recruitment end date
01/08/2010
Locations
Countries of recruitment
Germany
Study participating centre
Hindenburgdamm 30
Berlin
12200
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
c/o Dr. Krukenkamp
Charitéplatz 1
Virchowweg 1
Berlin
10117
Germany
c.krukenkamp@charite.de
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research council
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|