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The centralization phenomenon and stability in patients with low back pain.


- candidate number15657
- NTR NumberNTR4246
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2013
- Secondary IDsMETC VUmc 2013/16, WC2013-025 
- Public TitleThe centralization phenomenon and stability in patients with low back pain.
- Scientific TitleMDT evaluation and stability tests in patients with low back pain
- ACRONYM
- hypothesisFor clinicians, positive clinical tests for identification of lumbar spine instability are indicators for the use of stabilization exercises. However, it is our clinical experience that these tests frequently become negative after the patient has demonstrated a centralization response assessed with Mechanical Diagnosis & Therapy (MDT). Given that this response is commonly elicited during MDT assessment, it may be that instability tests should be preceded by a MDT assessment to ensure appropriate interpretation. The aim of this study will be to assess the influence of the centralization response on the outcome of instability tests in patients with low back pain. We hypothesize that the number of positive tests will reduce in patients whose pain centralizes, but that this will not be the case for patients who do not centralize.
- Healt Condition(s) or Problem(s) studiedStability, Low back pain (LBP)
- Inclusion criteriaLow back pain (LBP) as primary complaint, with or without associated leg pain, age over 17 years, and able to read and write Dutch
- Exclusion criteriaknown or suspected specific LBP (e.g., cauda equina compression, fractures), severe radiculopathy, spondylolisthesis (grade 2 or more), serious co-morbidity (e.g., metastases, AIDS, cerebrovascular accident), psychopathology, currently pregnant or given birth in the past three months, lumbar spinal surgery in the previous 6 months, increase of pain due to clinical instability tests by the first examiner or inability to demonstrate any LBP symptoms during mechanical examination
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2013
- planned closingdate1-apr-2014
- Target number of participants100
- InterventionsPatients will be recruited from a private physical therapy clinic. Each patient will be assessed by two examiners on the same day. The first examiner will conduct a standardized set of tests to identify signs of lumbar spine instability before and directly after a MDT session which is conducted by the second examiner. This second examiner will classify each patient as a centralizer or non-centralizer. The assessments of instability tests and the MDT assessment will be conducted independently and the examiners will be blinded to each otherís results. At least 100 patients will be included.
- Primary outcomeThe proportion of positive instability tests measured before and after the MDT session will be calculated for all patients as will their classification as a centralizer or non-centralizer. The differences between instability results pre and post-MDT will be reported as a percentage and investigated with X2 tests between the two groups.
- Secondary outcomeAs a secondary analysis, patients with a directional preference will be regarded centralizers and the same statistical tests will be used.
- TimepointsNA
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Apeldoorn
- CONTACT for SCIENTIFIC QUERIES A. Apeldoorn
- Sponsor/Initiator EMGO Institute, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
International Mechanical Diagnosis and Therapy Research Foundation www.imdtrf.org
- PublicationsN/A
- Brief summaryFor clinicians, positive clinical tests for identification of lumbar spine instability are indicators for the use of stabilization exercises. However, in our clinical experience these tests frequently become negative after the patient has demonstrated a centralization response assessed with Mechanical Diagnosis & Therapy (MDT). Given that this response is commonly elicited during MDT assessment, it may be that instability tests should be preceded by a MDT assessment to ensure appropriate interpretation. The aim of this study will be to assess the influence of the centralization response on the outcome of instability tests in patients with low back pain. Design: Observational study Methods: Patients will be recruited from a private physical therapy clinic. Each patient will be assessed by two examiners on the same day. The first examiner will conduct a standardized set of tests to identify signs of lumbar spine instability before and directly after a MDT session which is conducted by the second examiner. This second examiner will classify each patient as a centralizer or non-centralizer. The assessments of instability tests and the MDT assessment will be conducted independently and the examiners will be blinded to each otherís results. At least 100 patients will be included. The differences between pre-test and post-test results on the instability test will be described in percentages and via X2 tests for the two groups (centralizers and non-centralizers). Analyses will be performed to investigate whether selected baseline characteristics have an influence on the outcomes. The present study will contribute to our knowledge about the influence of MDT, and more specifically the centralization response, on clinical lumbar spine stabilization measures in patients with low back pain.
- Main changes (audit trail)
- RECORD3-nov-2013 - 20-nov-2013


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