The Direct-Physio Trial

NCT ID: NCT05215093

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Direct physiotherapy pathway

People with acute low back pain will directly go to a physiotherapist, who will treat the patient without prescription of the general practitioner.

Group Type: EXPERIMENTAL

Direct access physiotherapy for acute low back pain

Intervention Type: 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 pathway

People with low back pain will receive usual care by the general practitioner (with or without referral to physiotherapy).

Group Type: ACTIVE_COMPARATOR

Usual care for acute low back pain

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Axxon - the Belgian physiotherapy professional association

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Lotte Janssens

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lotte Janssens, PhD

Role: PRINCIPAL_INVESTIGATOR

UHasselt

Locations

REVAL Faculty of Rehabilitation Sciences

Diepenbeek, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Pieter Severijns, PhD

Role: CONTACT

pieter.severijns@uhasselt.be

+32477560517

Lotte Janssens, PhD

Role: CONTACT

lotte.janssens@uhasselt.be

Facility Contacts

Pieter Severijns

Role: primary

pieter.severijns@uhasselt.be

Other Identifiers

CME2021/066

Identifier Type: -

Identifier Source: org_study_id