Condition category
Musculoskeletal Diseases
Date applied
11/07/2008
Date assigned
19/08/2008
Last edited
19/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Rudwaleit

ORCID ID

Contact details

Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)30 8445 4547
martin.rudwaleit@charite.de

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

01/08/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.charite.de/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes