Previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (LBP), results in improved clinical outcomes, as well as reduced health-related costs. However, despite these results, the effectiveness of direct access to physiotherapy and its impact on costs has never been investigated in Belgium. Therefore, the goal of this study is to compare the (cost-)effectiveness of direct access to physiotherapy compared to usual care by the general practitioner (GP) for patients with acute LBP. In this study, 600 patients with acute LBP (lasting \>24 hours and \<6 weeks) will be divided into two groups (Dutch-speaking: n=2x150; French-speaking n= 2x150). One group will receive treatment through direct access to the physiotherapist, without prescription by a GP. The other group will follow the traditional care pathway through the GP. Th effects on pain, disability and cost-effectiveness will be analysed using questionnaires obtained before and at the end of treatment, after 3 months, after one and after two years. Primary outcomes include pain and disability. Secondary outcomes include clinical outcomes, beliefs related to LBP, quality of life, patient satisfaction, but also direct health care costs, health care resource use, as well as absenteeism and productivity loss. The results of this study will answer the question whether direct access to physiotherapy is (cost)effective for acute LBP. In the long term, these results might be used to optimize the care pathway in Belgium for patients with acute low back pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Interventions include physiotherapeutic treatment, without prescription of the general practitioner, for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.
Interventions include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.
REVAL Faculty of Rehabilitation Sciences
Diepenbeek, Belgium
RECRUITINGChanges in pain intensity
Numeric Rating Scale
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in pain location and extent
Pain Diagram of Margolis
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in disability
Oswestry Disability Index
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)
Costs of low back pain and its treatment in terms of medical and societal costs
Time frame: Up to 2 years after enrollment
Changes in beliefs and cognitions related to low back
Back Pain Attitude Questionnaire (Back-PAQ)
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in patient satisfaction
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in quality of life
EQ-5D
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Amount of / coping with flare-ups during follow-up
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
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