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NCT Number: NCT05215093

The Direct-Physio Trial

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physiotherapy Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REVAL Faculty of Rehabilitation Sciences

Diepenbeek, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Direct access physiotherapy for acute low back pain

Other

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.

Usual care for acute low back pain

Other

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

Primary outcomes

  1. Changes in pain intensity

    Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment

    Numeric Rating Scale

  2. Changes in pain location and extent

    Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment

    Pain Diagram of Margolis

  3. Changes in disability

    Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment

    Oswestry Disability Index

Secondary outcomes

  1. Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)

    Time frame: Up to 2 years after enrollment

    Costs of low back pain and its treatment in terms of medical and societal costs

  2. Changes in beliefs and cognitions related to low back

    Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment

    Back Pain Attitude Questionnaire (Back-PAQ)

  3. 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

  4. Changes in quality of life

    Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment

    EQ-5D

  5. 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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Axxon - the Belgian physiotherapy professional association
  • KU Leuven
  • Riziv-Inami - National Institute for the Sickness and Invalidity Insurance
  • Universiteit Antwerpen
  • Université Catholique de Louvain

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2022
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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