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Inter-examiner reliability of diagnostic criteria
ISRCTN ISRCTN43417727
DOI 10.1186/ISRCTN43417727
ClinicalTrials.gov identifier
EudraCT number
Public title Inter-examiner reliability of diagnostic criteria
Scientific title Inter-examiner reliability of diagnostic criteria for diagnosing sacroiliac joint - discogenic and facet joint pain
Acronym N/A
Serial number at source NL36822.078.11
Study hypothesis 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.
Lay summary 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
Ethics approval 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.
Study design Observational study
Countries of recruitment Netherlands
Disease/condition/study domain Chronic low back pain
Participants - inclusion criteria 1. Age 18 years or older
2. Chronic low back pain lasting for more than 3 months
Participants - exclusion criteria Presence of red flags as possible fracture, tumor or infection
Anticipated start date 10/01/2013
Anticipated end date 10/01/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions 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.
Primary outcome measure(s) The results of the diagnostic tests by two pain specialists and one orthopaedic surgeon.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Centre for Pain Medicine, Erasmus University MC, Rotterdam, Netherlands.
Trial website
Publications
Contact name Dr  Cornelis Wilhelmus Jacobus  van Tilburg
  Address Multidisciplinary pain centre
Lievensberg hospital
Boerhaaveplein 1
  City/town Bergen op Zoom
  Zip/Postcode 4624 VT
  Country Netherlands
Sponsor Erasmus University Medical Centre (MC) (Netherlands)
  Address c/o Frank Huygen
Centre for Pain Medicine
's-Gravendijkwal 230
  City/town Rotterdam
  Zip/Postcode 3015 CE
  Country Netherlands
Date applied 09/07/2013
Last edited 18/07/2013
Date ISRCTN assigned 18/07/2013
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