Status:
UNKNOWN
The Direct-Physio Trial
Lead Sponsor:
Hasselt University
Collaborating Sponsors:
KU Leuven
Universiteit Antwerpen
Conditions:
Low Back Pain
Physiotherapy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05215093
Start Date
December 1 2022
End Date
December 1 2024
Last Update
February 28 2023
Active Locations (1)
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1
REVAL Faculty of Rehabilitation Sciences
Diepenbeek, Belgium, 3590