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Development of the Nijmegen Decision Tool for chronic low back pain to guide patient triage and treatment.


- candidate number24582
- NTR NumberNTR5946
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2016
- Secondary IDs2921 Innovatiefonds Zorgverzekeraars
- Public TitleDevelopment of the Nijmegen Decision Tool for chronic low back pain to guide patient triage and treatment.
- Scientific TitlePatient profiles to guide patient triage and treatment. Developmet and validation of the Nijmegen Decision Tool for Chronic Low Back Pain (NDT-CLBP)
- ACRONYMNDT-CLBP
- hypothesisThe NDT-CLBP is a valid tool to guide treatment based on patient profiles for secondary spine care professionals
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP), Decision-making
- Inclusion criteriaPatients referred with chronic low back pain:
- adults, aged 18 years and older
- duration of low back pain complaints for 3 months or more
- Exclusion criteria- acute low back pain complaints
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate1-jan-2019
- Target number of participants1000
- InterventionsNDT-CLBP;p decision for treatment and teratment as usual
- Primary outcomeFunctional ability
- Secondary outcomePain; Quality of Life; Satisfaction Measures of efficiency, relevance, usability for patients and professioonals
- TimepointsFollows usual care pathways - systematic outcome monitoring:
pre-treatment; (6 months follow up); 12 and 24 months follow up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Miranda van Hooff
- CONTACT for SCIENTIFIC QUERIESMSc Miranda van Hooff
- Sponsor/Initiator Sint Maartenskliniek Nijmegen, VU University Medical Center, EMGO Institute
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsseveral publications planned for 2016 and further
- Brief summaryLow back pain (LBP) is responsible for the greatest burden of all diseases. Chronic Low Back Pain (CLBP) is among the most common reasons why patients visit a spine surgeon. As the CLBP population is heterogeneous, it remains a challenge to address etiology and to suggest treatment options. (Inter-)National guidelines recommend to develop a decision tool to triage towards either surgical or nonsurgical interventions.

The Nijmegen decision tool, consisting of a web-based screening questionnaire, a systematic follow up of outcomes (i.e. outcome monitoring) built in the patient-based system of the SweSpine outcomes Registry, is developed to support patient-triage and is based on evidence and professional (Delphi) consensus. Since April2012 all new patients complete the questionnaire as a part of usual care, consisting of several indicators potentially predicting successful treatment outcome or persistence of pain complaints, and are systematically followed over time.

In this study pre-intervention patient profiles have been determined and a decision tool ('proof-of-principle') will be developed, based on indicators predicting successful or non-response at one-year follow-up outcome of spine surgery, of a non-surgical, multidisciplinary Combined Physical and Psychological (CPP) program and of counseling (including physical therapy in primary care). After pilot testing, the tool will be implemented in other spine clincics and externally validated.
- Main changes (audit trail)
- RECORD7-jul-2016 - 23-aug-2016


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