- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central Region
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Herning, Central Region, Denmark, 7400
- Department of Occ. Medicine
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Southern Denmark
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Middelfart, Southern Denmark, Denmark, 5500
- Centre for Quality
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stratified care
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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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. |
Active Comparator: Current care
Treatment based on clinical judgement, clinical need and patient preferences.
No access to guidance tools.
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Treatment based on clinical judgement, clinical need and patient preferences.
No access to guidance tools.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported change measured by the Roland Morris Disability Questionnaire
Time Frame: 3 and 12 months
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Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
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3 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
Time Frame: 12 months
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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
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12 months
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Change in pain intensity measured on a numeric range scale
Time Frame: 3 and 12 months
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Change in pain intensity is monitored on numeric range scales indicating back and leg pain.
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3 and 12 months
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Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)
Time Frame: 3 and 12 months
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Short and long term time of work is monitored by standardized data from the Danish National Register on Public Transfer Payments (DREAM)
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3 and 12 months
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Time off work monitored by standardized patient reported data
Time Frame: 3 and 12 months
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Short and long term time of work is monitored by standardized patient reported data
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3 and 12 months
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Patient reported global change measured by the questionnaire "Global Impression of Change"
Time Frame: 3 and 12 months
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Patients perception of global change is monitored by the questionnaire "Global Impression of Change"
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3 and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars Morsø, Ph.D, Centre for Quality, Institute for Regional Healthresearch
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20140205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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