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

R

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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