Background Studies in the United Kingdom find the stratified care model of the STarT Back Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients. However, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services. Objective To investigate the effectiveness of the stratified care model of the SBT, when embedded into the regional disease management programs on LBP in primary care as compared to current best practice care.
Methods The study is a two-armed randomized controlled trial in Danish primary health care setting. In total 700 patients are included in the study. The patients are randomised automatically by a developed database to; 1) Stratified care (treatment matched to stratification according to SBT) or 2) Control treatment (treatment based solely on clinical reasoning). All data including patient consent is collected and monitored using a web-based data management system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
333
Patients are stratified according to the SBT subgroups (low, medium and high risk) and the appropriate matched intervention will be delivered accordingly. Low risk: Reassuring information. Onwards referral, investigation or further treatment is not recommended Medium risk: In addition to reassuring information patients receive evidence based individualised treatment focusing on restoring function (targeting back pain, leg pain, co-morbid pain and disability) High risk : In addition to medium risk treatment patients will receive individualised psychologically informed physiotherapy aiming to reduce pain and disability.
Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.
Department of Occ. Medicine
Herning, Central Region, Denmark
Centre for Quality
Middelfart, Southern Denmark, Denmark
Patient reported change measured by the Roland Morris Disability Questionnaire
Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
Time frame: 3 and 12 months
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
The health economic analysis will test the cost-effectiveness/cost-utility of SBT against current practice. Patient reported quality of life on the EuroQol (EQ-5D) questionnaire
Time frame: 12 months
Change in pain intensity measured on a numeric range scale
Change in pain intensity is monitored on numeric range scales indicating back and leg pain.
Time frame: 3 and 12 months
Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)
Short and long term time of work is monitored by standardized data from the Danish National Register on Public Transfer Payments (DREAM)
Time frame: 3 and 12 months
Time off work monitored by standardized patient reported data
Short and long term time of work is monitored by standardized patient reported data
Time frame: 3 and 12 months
Patient reported global change measured by the questionnaire "Global Impression of Change"
Patients perception of global change is monitored by the questionnaire "Global Impression of Change"
Time frame: 3 and 12 months
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