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

September 9, 2019 updated by: Lars Morsoe, Region of Southern Denmark

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Central Region
      • Herning, Central Region, Denmark, 7400
        • Department of Occ. Medicine
    • Southern Denmark
      • Middelfart, Southern Denmark, Denmark, 5500
        • Centre for Quality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

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
Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
3 and 12 months

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
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
Time Frame: 3 and 12 months
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)
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)
3 and 12 months
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
3 and 12 months
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"
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lars Morsø, Ph.D, Centre for Quality, Institute for Regional Healthresearch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

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.

Clinical Trials on Low Back Pain

Clinical Trials on Stratified care

3
Subscribe