Prevalence of SpondyloArthropathies in Norfolk

ISRCTN	ISRCTN76873217
DOI	https://doi.org/10.1186/ISRCTN76873217
Secondary identifying numbers	N/A

Submission date: 20/07/2011
Registration date: 07/11/2011
Last edited: 14/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Louise Hamilton
Scientific

Rheumatology Department
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Email	louise.hamilton@nnuh.nhs.uk

Study information

Study design	Single-centre cross-sectional cohort study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The prevalence of inflammatory back pain and SpondyloArthropathies in a primary care population in Norfolk
Study 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(s)	NRES Committee East of England, Norfolk, 05/08/2011, ref: 11/EE/0245
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
Primary outcome measure	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 study start date	01/09/2011
Overall study end date	01/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1000
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 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

England
United Kingdom

Study participating centre

Norfolk and Norwich University Hospital

Norwich
NR4 7UY
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

Norwich Research Park
Norwich
NR4 7TJ
England
United Kingdom

Website	http://www.uea.ac.uk/
"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Industry

Pfizer (UK)
Government organisation / For-profit companies (industry)

Alternative name(s): Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No
Results article	results	21/12/2015		Yes	No

Editorial Notes

14/01/2016: Publication reference added.