Clinical trial NCT05215093: The Direct-Physio Trial
Official title: Direct Access to Physiotherapy for Acute Low Back Pain: a Pragmatic Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Physiotherapy
Keywords: Direct access
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Universiteit Antwerpen
name: Université Catholique de Louvain
name: Axxon - the Belgian physiotherapy professional association
name: Riziv-Inami - National Institute for the Sickness and Invalidity Insurance
First posted: 2022-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Changes in pain intensity
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
measure: Changes in pain location and extent
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
measure: Changes in disability
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Secondary outcomes:
measure: Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)
timeFrame: Up to 2 years after enrollment
measure: Changes in beliefs and cognitions related to low back
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
measure: Changes in patient satisfaction
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
measure: Changes in quality of life
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
measure: Amount of / coping with flare-ups during follow-up
timeFrame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: REVAL Faculty of Rehabilitation Sciences
Study officials:
affiliation: UHasselt
name: Lotte Janssens, PhD
role: PRINCIPAL_INVESTIGATOR
References: