Low Back Pain - What's Next? Stratified Care Compared to Current Practice
- Conditions
- Low Back Pain
- Interventions
- Other: Stratified careOther: Current care
- Registration Number
- NCT02612467
- Lead Sponsor
- Region of Southern Denmark
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- patients found eligible for referral to physiotherapy by the general practitioner (GP)
- 18 years and above
- understand Danish language.
- Serious pathology (malignancy, inflammatory arthritis, etc.),
- serious nerve root compression (cauda equina, paresis <3),
- influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratified care Stratified care Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group Current care Current care Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.
- Primary Outcome Measures
Name Time Method Patient reported change measured by the Roland Morris Disability Questionnaire 3 and 12 months Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
- Secondary Outcome Measures
Name Time Method Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM) 3 and 12 months Short and long term time of work is monitored by standardized data from the Danish National Register on Public Transfer Payments (DREAM)
Patient reported global change measured by the questionnaire "Global Impression of Change" 3 and 12 months Patients perception of global change is monitored by the questionnaire "Global Impression of Change"
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire 12 months 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
Change in pain intensity measured on a numeric range scale 3 and 12 months Change in pain intensity is monitored on numeric range scales indicating back and leg pain.
Time off work monitored by standardized patient reported data 3 and 12 months Short and long term time of work is monitored by standardized patient reported data
Trial Locations
- Locations (2)
Centre for Quality
🇩🇰Middelfart, Southern Denmark, Denmark
Department of Occ. Medicine
🇩🇰Herning, Central Region, Denmark