Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT05215093
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05215093
Study Brief:
Protocol Section:
NCT05215093