The Direct-Physio Trial

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215093
• Other study ID #: CME2021/066
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Hasselt University
• Contact: Pieter Severijns, PhD
• Phone: +32477560517
• Email: pieter.severijns[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Physiotherapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	REVAL Faculty of Rehabilitation Sciences	Diepenbeek

Sponsors (6)

Lead Sponsor	Collaborator
Hasselt University	Axxon - the Belgian physiotherapy professional association, KU Leuven, Riziv-Inami - National Institute for the Sickness and Invalidity Insurance, Université Catholique de Louvain, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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