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

Region of Southern Denmark

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Stratified care; Other: Current care

Study type: Interventional

Funder types: Other

Identifiers

NCT02612467

S-20140205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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333 participants in 2 patient groups

Stratified care

Experimental group

Description:

Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group

Treatment:

Other: Stratified care

Current care

Active Comparator group

Description:

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

Treatment:

Other: Current care