Low Back Pain - What's Next? Stratified Care Compared to Current Practice

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of a Stratified Care Model for Non-specific Low Back Pain in Danish Primary Care Compared to Current Practice in a Randomised Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Stratified care
* Other: Current care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients found eligible for referral to physiotherapy by the general practitioner (GP) 18 years and above understand Danish language. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratified care<br>Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group | Other: Stratified care<br>* 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.<br>|
| Active Comparator: Current care<br>Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. | Other: Current care<br>* Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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) | 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 | 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 | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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start back tool, stratified care, targeted treatment