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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-15

Brief Summary

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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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Detailed Description

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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

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Stratified care

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Current care

Intervention Type OTHER

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

Interventions

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Stratified care

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.

Intervention Type OTHER

Current care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No