Inter-examiner reliability of diagnostic criteria
| ISRCTN | ISRCTN43417727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43417727 |
| Protocol serial number | NL36822.078.11 |
| Sponsor | Erasmus University Medical Centre (MC) (Netherlands) |
| Funder | Centre for Pain Medicine, Erasmus University MC, Rotterdam, Netherlands. |
- 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
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
Scientific
Multidisciplinary pain centre
Lievensberg hospital
Boerhaaveplein 1
Bergen op Zoom
4624 VT
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | Other |
| Study type | Participant 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(s) |
The results of the diagnostic tests by two pain specialists and one orthopaedic surgeon. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
4624 VT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/05/2020: Publication reference and total final enrolment number added.
