Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 10:39 PM
Study NCT ID:
NCT02612467
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2015-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Back Pain - What's Next? Stratified Care Compared to Current Practice
Sponsor:
Region of Southern Denmark
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: