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| Name | Class |
|---|---|
| Herning Hospital | OTHER |
| Research Unit of General Practice, Odense | OTHER |
| Spine Centre of Southern Denmark | OTHER |
| Keele University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratified care | Experimental | Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group |
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| Current care | Active Comparator | Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratified care | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Morsø, Ph.D | Centre for Quality, Institute for Regional Healthresearch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Occ. Medicine | Herning | Central Region | 7400 | Denmark | ||
| Centre for Quality |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21769444 | Background | Morso 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. | |
| 21963002 | Result | 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 randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| OTHER |
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| Current care | Other | Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. |
|
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 |
| Middelfart |
| Southern Denmark |
| 5500 |
| Denmark |
| 34101953 | Derived | Morso L, Olsen Rose K, Schiottz-Christensen B, Sowden G, Sondergaard J, Christiansen DH. Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial. Eur J Pain. 2021 Oct;25(9):2020-2038. doi: 10.1002/ejp.1818. Epub 2021 Jul 2. |
| 29884217 | Derived | Morso L, Schiottz-Christensen B, Sondergaard J, Andersen NV, Pedersen F, Olsen KR, Jensen MS, Hill J, Christiansen DH. The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial. Trials. 2018 Jun 8;19(1):315. doi: 10.1186/s13063-018-2685-5. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |