The Direct-Physio Trial

Summary

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.

Conditions

• Low Back Pain
• Physiotherapy

Interventions

OTHER

Direct access physiotherapy for acute low back pain

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.

OTHER

Usual care for acute low back pain

Interventions include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• Axxon - the Belgian physiotherapy professional association

  collaborator UNKNOWN

• Riziv-Inami - National Institute for the Sickness and Invalidity Insurance

  collaborator UNKNOWN

• Hasselt University

  lead OTHER

Principal Investigators

• Lotte Janssens, PhD · UHasselt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Belgium

Study Locations