Condition category
Musculoskeletal Diseases
Date applied
20/07/2011
Date assigned
07/11/2011
Last edited
14/01/2016
Prospective/Retrospective
Retrospectively 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 Louise Hamilton

ORCID ID

Contact details

Rheumatology Department
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
-
louise.hamilton@nnuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The prevalence of inflammatory back pain and SpondyloArthropathies in a primary care population in Norfolk

Acronym

PSpAN

Study hypothesis

Axial SpA (AS) is an inflammatory condition affecting the spine, peripheral joints and extra-articular systems. Untreated it can lead to ankylosis of the sacro-iliac joints and spine. Anti-TNF drugs can improve symptoms, but drug-free remission can usually be achieved only in patients with early disease who have not yet developed radiographic changes. There is therefore a pressing need to identify patients early in the course of disease. One way to do this is to find those with inflammatory back pain (IBP), the earliest and commonest symptom of SpA.

Estimates of the prevalence of IBP in the UK are based on a single study, published in 1995 [Underwood and Dawes. Br J Rheumatol 1995; 34:1074-7]. In this study, 313 patients with chronic back pain were screened for inflammatory back pain using a GP-administered questionnaire. 15% scored positively and were subsequently examined. Two patients were found to have AS, and 18 had features of an inflammatory arthropathy. The authors concluded that up to 5% of patients with chronic back pain might have a mild form of AS.

We have developed and validated a patient-administered questionnaire and want to use this in a primary care population with low back pain to identify those with possible inflammation. Advances in imaging techniques, and the more widespread availability of magnetic resonance imaging (MRI) scanning in the past 15 years, should allow us to identify with more certainty which of those patients with IBP actually have an inflammatory spondyloarthropathy.

This will enable us to determine the prevalence of inflammatory back pain and SpA in primary care, and evaluate the diagnostic utility of various clinical parameters.

Ethics approval

NRES Committee East of England, Norfolk, 05/08/2011, ref: 11/EE/0245

Study design

Single-centre cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Axial spondyloarthropathy, ankylosing spondylitis

Intervention

Participants will be asked to complete a screening questionnaire for inflammatory back pain. A subgroup (comprising 75 positive-scoring cases and 25 age and sex-matched negative-scoring controls) will then be assessed more fully with history and examination, a blood test for HLA-B*27 and erythrocyte sedimentation rate (ESR), and outcome measure questionnaires [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life (ASQoL)]. This group will also be invited to have an MRI scan of the sacroiliac joints and whole spine. Follow-up will end after the MRI scan.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Inflammatory back pain questionnaire score

Secondary outcome measures

1. MASES
2. HLA-B*27 status
3. BASDAI
4. BASFI
5. BASMI
6. ASQoL
7. AS-DAS
8. MRI scan result

Overall trial start date

01/09/2011

Overall trial end date

01/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged 18 and over
2. Have ever attended GP with back pain
3. Willing and able to give informed consent to take part in study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Unwilling to take part in study
2. Identified as unsuitable for inclusion by GP
3. Unable to communicate in English (as screening questionnaire not validated in translation)
4. Patients will be excluded from the MRI scanning phase of the study if this is contra-indicated (e.g. cardiac pacemaker)

Recruitment start date

01/09/2011

Recruitment end date

01/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Industry

Funder name

Pfizer (UK)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24136063
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26690935

Publication citations

Additional files

Editorial Notes

14/01/2016: Publication reference added.