Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)(COMPLETED)

Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00726765

Enrollment

1090

Registered

2008-08-01

Start date

2008-06-30

Completion date

2010-05-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis, Spinal Spondyloarthropathies

Brief summary

This is a multi-national, multi-site, observational study to determine which of two strategies, when used by referring physicians is superior in the diagnosis of axial spondyloarthritis (AS) by rheumatologists.

Detailed description

Subjects will be selected using a non-probability sampling method. For each center of excellence, the local network of referring physicians will be assigned, according to a random code in a 1:1 ratio, to use one of the two referral strategies for eligible patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A subject must have back pain of unknown origin, of more than 3 months' duration, and with onset before age 45. * A subject must be willing to give written informed consent and be able to adhere to visit schedules.

Exclusion criteria

* Established diagnosis of spondyloarthropathies at the time of referral. * Any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Design outcomes

Primary

Measure	Time frame
To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists.	Approximately 3-6 months

Secondary

Measure	Time frame
To determine which of the referral criteria proposed, or which combination of referral criteria, is the most successful and workable in the diagnosis of AS when used by referring physicians.	Approximately 3-6 months
To describe the demographics and disease characteristics of patients diagnosed with AS.	Approximately 3-6 months
To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS.	Approximately 3-6 months

Outcome results