Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cornelis Wilhelmus Jacobus van Tilburg

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL36822.078.11

Study information

Scientific title

Inter-examiner reliability of diagnostic criteria for diagnosing sacroiliac joint - discogenic and facet joint pain

Acronym

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.

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

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

The results of the diagnostic tests by two pain specialists and one orthopaedic surgeon.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/2013

Overall trial end date

10/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or older
2. Chronic low back pain lasting for more than 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

Presence of red flags as possible fracture, tumor or infection

Recruitment start date

10/01/2013

Recruitment end date

10/01/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Multidisciplinary pain centre
Bergen op Zoom
4624 VT
Netherlands

Sponsor information

Organisation

Erasmus University Medical Centre (MC) (Netherlands)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Editorial Notes