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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612467
• Other study ID #: S-20140205
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 15, 2018

Study information

• Verified date: September 2019
• Source: Region of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• Current care
Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

Locations

Country	Name	City	State
Denmark	Department of Occ. Medicine	Herning	Central Region
Denmark	Centre for Quality	Middelfart	Southern Denmark

Sponsors (5)

Lead Sponsor	Collaborator
Region of Southern Denmark	Herning Hospital, Keele University, Research Unit of General Practice, Odense, Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomi — View Citation

Morsø L, Albert H, Kent P, Manniche C, Hill J. Translation and discriminative validation of the STarT Back Screening Tool into Danish. Eur Spine J. 2011 Dec;20(12):2166-73. doi: 10.1007/s00586-011-1911-6. Epub 2011 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Information regarding STarT Back Tool on the Keele University Homepage