The Direct-Physio Trial

NCT05215093 | Unknown

• 1 other identifier: CME2021/066
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

Direct access

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

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

  Up to 2 years after enrollment

• Changes in beliefs and cognitions related to low back

  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

  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

Study Arms (2)

Direct physiotherapy pathway

EXPERIMENTAL

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

Usual care pathway

ACTIVE COMPARATOR

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

Interventions

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.

Direct physiotherapy pathway

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.

Usual care pathway

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recent lumbar surgery (\< 1 year)
• Pregnancy
• History of (any) treatment for the current pain episode
• Generalized musculoskeletal pain (based on fibromyalgia criteria) (Galvez-Sánchez and Reyes del Paso 2020).

Sponsors & Collaborators

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

Study Sites (1)

REVAL Faculty of Rehabilitation Sciences

Diepenbeek, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lotte Janssens, PhD

  UHasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Severijns, PhD

CONTACT

+32477560517; pieter.severijns@uhasselt.be

Lotte Janssens, PhD

CONTACT

lotte.janssens@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 31, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

BE (1)