The Direct-Physio Trial

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Physiotherapy
• Intervention / Treatment: Other: Direct access physiotherapy for acute low back pain; Other: Usual care for acute low back pain

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pieter Severijns, PhD; Phone Number: +32477560517; Email: pieter.severijns@uhasselt.be
• Study Contact Backup: Name: Lotte Janssens, PhD; Email: lotte.janssens@uhasselt.be

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Recruiting
    • REVAL Faculty of Rehabilitation Sciences
    • Contact: Pieter Severijns; Email: pieter.severijns@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Usual care pathway; 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 include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: KU Leuven; Université Catholique de Louvain; Universiteit Antwerpen; Axxon - the Belgian physiotherapy professional association; Riziv-Inami - National Institute for the Sickness and Invalidity Insurance
• Investigators: Principal Investigator: Lotte Janssens, PhD, UHasselt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Direct access
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CME2021/066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No