NCT02612467

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Region of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Stratified care	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.
OTHER	Current care	Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-12-15
• Completion: 2018-12-15
• First posted: 2015-11-23
• Last updated: 2019-09-10

Locations

2 sites across 1 country: Denmark