The Direct-Physio Trial

Study Overview
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Brief Summary
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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.

Official Title
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Direct Access to Physiotherapy for Acute Low Back Pain: a Pragmatic Pilot Trial

Conditions
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Low Back Pain, Physiotherapy

Intervention / Treatment
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* Other: Direct access physiotherapy for acute low back pain
* Other: Usual care for acute low back pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-specific acute LBP defined as (based on Nicol et al. 2020): pain between the 12th rib and buttocks associated or not with non-dominant leg pain looking for LBP care for the first time in case of first episode, OR for the first time for the current episode in case of recurrent or persistent LBP lasting > 24 hours and < 6 weeks with an average pain intensity during the past 24 hours of ≥ 3 on an 11-point Numerical Pain Rating Scale with an Oswestry Disability Index score (version 2.1a) of at least 20% (Denteneer et al. 2018). Patients aged between 18 and 65 years Exclusion Criteria: Recent lumbar surgery (< 1 year) Pregnancy History of (any) treatment for the current pain episode Red flags suggesting specific LBP (e.g. resulting from infection or neoplasm, cauda equina), based on the Belgian Health Care Knowledge Center (KCE, BEL) who published evidence-based guidelines to manage LBP and radicular pain (Van Wambeke et al. 2017), leads to exclusion from treatment within the study. Generalized musculoskeletal pain (based on fibromyalgia criteria) (Galvez-Sánchez and Reyes del Paso 2020).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct physiotherapy pathway<br>People with acute low back pain will directly go to a physiotherapist, who will treat the patient without prescription of the general practitioner. | Other: Direct access physiotherapy for acute low back pain<br>* 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.<br>|
| Active Comparator: Usual care pathway<br>People with low back pain will receive usual care by the general practitioner (with or without referral to physiotherapy). | Other: Usual care for acute low back pain<br>* Interventions include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain intensity | Numeric Rating Scale | 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 | 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 | Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 2 years after enrollment | 
| Changes in beliefs and cognitions related to low back | Back Pain Attitude Questionnaire (Back-PAQ) | 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 |  | 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 | 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 |  | Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct access