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Completed

NCT Number: NCT02612467

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Occ. Medicine, Herning, Central Region, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Current care

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire

    Time frame: 12 months

    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

  2. Change in pain intensity measured on a numeric range scale

    Time frame: 3 and 12 months

    Change in pain intensity is monitored on numeric range scales indicating back and leg pain.

  3. Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)

    Time frame: 3 and 12 months

    Short and long term time of work is monitored by standardized data from the Danish National Register on Public Transfer Payments (DREAM)

  4. Time off work monitored by standardized patient reported data

    Time frame: 3 and 12 months

    Short and long term time of work is monitored by standardized patient reported data

  5. Patient reported global change measured by the questionnaire "Global Impression of Change"

    Time frame: 3 and 12 months

    Patients perception of global change is monitored by the questionnaire "Global Impression of Change"

Sponsors and collaborators

Lead sponsor

Region of Southern Denmark

Other

Collaborators

  • Herning Hospital
  • Keele University
  • Research Unit of General Practice, Odense
  • Spine Centre of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2015
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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