Low Back PainNCT02612467
Low Back Pain - What's Next? Stratified Care Compared to Current Practice
A study testing Stratified care and Current care in people with Low Back Pain, run by Region of Southern Denmark at 2 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Stratified care and Current care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2015to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients found eligible for referral to physiotherapy by the general practitioner (GP)
- 18 years and above
- understand Danish language.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Occ. Medicine
Herning, Central Region, 7400
Centre for Quality
Middelfart, Southern Denmark, 5500
About this study
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
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.
Read the 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
- Being tested
- Stratified care, Current care
- Keywords
- start back tool, stratified care, targeted treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratified careOther
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 careOther
Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stratified care |
| Current care | Active comparator | Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. Receives: Other: Current care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 and 12 months
Secondary outcomes (5)
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
Measured: 12 months
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.
Measured: 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)
Measured: 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
Measured: 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"
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Herning Hospital, Research Unit of General Practice, Odense, Spine Centre of Southern Denmark, Keele University
- Responsible party
- Principal investigator, Lars Morsoe, Region of Southern Denmark
- Investigators
- Lars Morsø, Ph.D, Principal investigator, Centre for Quality, Institute for Regional Healthresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612467
- Sponsor's protocol ID
- S-20140205
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2015
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21769444Hill 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.
PubMed 21963002Morso 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.
PubMed 34101953Morso 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.
PubMed 29884217
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02612467
- Acronym / sponsor ID
- S-20140205
- Conditions
- Low Back Pain
- Keywords
- start back tool, stratified care, targeted treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- Herning Hospital, Research Unit of General Practice, Odense, Spine Centre of Southern Denmark, Keele University
- Study start
- Nov 2015
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratified care | Experimental | Other: Stratified carePatients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group |
| Current care | Active comparator | Other: Current careTreatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients found eligible for referral to physiotherapy by the general practitioner (GP)
- 18 years and above
- understand Danish language.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stratified carePatients 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 | Stratified care |
| Current careTreatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools. | Other | Current care |
Primary outcome
Patient reported change measured by the Roland Morris Disability Questionnaire
Time frame: 3 and 12 months
Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
5 secondary outcomes
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
Time frame: 12 months
Change in pain intensity measured on a numeric range scale
Time frame: 3 and 12 months
Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)
Time frame: 3 and 12 months
Time off work monitored by standardized patient reported data
Time frame: 3 and 12 months
Patient reported global change measured by the questionnaire "Global Impression of Change"
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 21769444Morso 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.
- Results publication: PubMed 21963002Hill 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.
- Derived from this study: PubMed 34101953Morso 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.
- Derived from this study: PubMed 29884217Morso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Morsø, Ph.D principal investigator
Centre for Quality, Institute for Regional Healthresearch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratified care and Current care in people with Low Back Pain, run by Region of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported change measured by the Roland Morris Disability Questionnaire (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612467, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.