Inter-examiner reliability of diagnostic criteria

ISRCTN	ISRCTN43417727
DOI	https://doi.org/10.1186/ISRCTN43417727
Secondary identifying numbers	NL36822.078.11

Submission date: 09/07/2013
Registration date: 18/07/2013
Last edited: 29/05/2020

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 of protocol

Background and study aims
Different types of low back pain (e.g. sacroiliac, discogenic and facet joint pain) have been identified. Treatment has become more effective due to the availability of specific treatments. Several diagnostic tests have been developed, but little is known about whether different doctors use the same diagnostic tests. This study aims to find out the inter-examiner reliability of the different clinical tests used to diagnose patients.

Who can participate?
Patients aged 18 or over with signs and symptoms of low back pain.

What does the study involve?
A physical examination of patients is done independently by two experienced pain specialists and one experienced surgeon. The list of tests prescribed by the three doctors are then compared and the tests are judged based on their presence in the list.

What are the possible benefits and risks of participating?
Improving diagnostic tests for identifying subtypes of low back pain increases the possibility for better treatment. We expect that this will improve overall success in treatment. No major risks are involved in this study.

Where is the study run from?
This study is run from Lievensberg Hospital, Bergen op Zoom, The Netherlands.

When is the study starting and how long is it expected to run for?
The study started in January 2013 and is expected to run for two years.

Who is funding the study?
This study is funded by the Centre for Pain Medicine, Erasmus University MC, Rotterdam, The Netherlands.

Who is the main contact?
C.W.J. van Tilburg, MD, FIPP
vtilburg@ziggo.nl

Contact information

Dr Cornelis Wilhelmus Jacobus van Tilburg
Scientific

Multidisciplinary pain centre
Lievensberg hospital
Boerhaaveplein 1
Bergen op Zoom
4624 VT
Netherlands

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Inter-examiner reliability of diagnostic criteria for diagnosing sacroiliac joint - discogenic and facet joint pain
Study objectives	Investigate the inter-examiner reliability of diagnostic tests in diagnosing sacroiliac joint - discogenic and facet joint pain. Our study aims to assess the reliability between examiners (pain specialists and orthopedic surgeons are involved) of the clinical tests used to select the patients in these studies.
Ethics approval(s)	Ethics approval has been granted by the Medical Ethics Committee (Medisch Ethische Toetsings Commissie) (METC) Erasmus MC, Rotterdam, The Netherlands on 14th November, 2012, reference number MEC-2011-246.
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	Patients will receive three separate consultations from two anaesthesiologist-pain specialists and one orthopaedic surgeon, during which every item from the list with diagnostic criteria are judged on their presence or absence.
Intervention type	Other
Primary outcome measure	The results of the diagnostic tests by two pain specialists and one orthopaedic surgeon.
Secondary outcome measures	Not provided at time of registration
Overall study start date	10/01/2013
Completion date	10/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	180
Total final enrolment	100
Key inclusion criteria	1. Age 18 years or older 2. Chronic low back pain lasting for more than 3 months
Key exclusion criteria	Presence of red flags as possible fracture, tumor or infection
Date of first enrolment	10/01/2013
Date of final enrolment	10/01/2015

Locations

Countries of recruitment

Netherlands

Study participating centre

Multidisciplinary pain centre

Bergen op Zoom
4624 VT
Netherlands

Sponsor information

Erasmus University Medical Centre (MC) (Netherlands)
University/education

c/o Frank Huygen
Centre for Pain Medicine
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

"ROR"	https://ror.org/018906e22

Funders

Funder type

University/education

Centre for Pain Medicine, Erasmus University MC, Rotterdam, Netherlands.

No information available

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	28/05/2018	29/05/2020	Yes	No

Editorial Notes

29/05/2020: Publication reference and total final enrolment number added.