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 |
| Protocol serial number | N/A |
| Sponsor | Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany) |
| Funder | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
- 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
Scientific
Hindenburgdamm 30
Berlin
12200
Germany
| Phone | +49 (0)30 8445 4547 |
|---|---|
| martin.rudwaleit@charite.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational diagnostic accuracy study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) | Sensitivity, specificity and positive likelihood-ratio (LR+) if two out of four parameters of IBP are present. |
| Key secondary outcome measure(s) | Sensitivity, specificity and positive likelihood-ratio (LR+) if three or four out of four parameters of IBP are present. |
| Completion date | 01/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
12200
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
