Clinical trial NCT02612467: Low Back Pain - What's Next? Stratified Care Compared to Current Practice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: start back tool
stratified care
targeted treatment
Lead sponsor: Region of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Herning Hospital
name: Research Unit of General Practice, Odense
name: Spine Centre of Southern Denmark
name: Keele University
First posted: 2015-11-23
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient reported change measured by the Roland Morris Disability Questionnaire
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
timeFrame: 12 months
measure: Change in pain intensity measured on a numeric range scale
timeFrame: 3 and 12 months
measure: Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)
timeFrame: 3 and 12 months
measure: Time off work monitored by standardized patient reported data
timeFrame: 3 and 12 months
measure: Patient reported global change measured by the questionnaire "Global Impression of Change"
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of Occ. Medicine
state: Central Region
city: Middelfart
country: Denmark
facility: Centre for Quality
state: Southern Denmark
Study officials:
affiliation: Centre for Quality, Institute for Regional Healthresearch
name: Lars Morsø, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.