The Direct-Physio Trial

Not Applicable

Recruiting

• Conditions: Low Back Pain; Physiotherapy
• Interventions: Other: Direct access physiotherapy for acute low back pain; Other: Usual care for acute low back pain

• Registration Number: NCT05215093
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-31
• Study Start: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct physiotherapy pathway	Direct access physiotherapy for acute low back pain	People with acute low back pain will directly go to a physiotherapist, who will treat the patient without prescription of the general practitioner.
Usual care pathway	Usual care for acute low back pain	People with low back pain will receive usual care by the general practitioner (with or without referral to physiotherapy).

Primary Outcome Measures

Name	Time	Method
Changes in pain location and extent	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
Changes in pain intensity	Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment	Numeric Rating Scale
Changes in disability	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 Outcome Measures

Name	Time	Method
Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)	Up to 2 years after enrollment	Costs of low back pain and its treatment in terms of medical and societal costs
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
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	Back Pain Attitude Questionnaire (Back-PAQ)
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	EQ-5D

Trial Locations

Locations (1)

REVAL Faculty of Rehabilitation Sciences; 🇧🇪 Diepenbeek, Belgium