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:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT05706103
Eligibility Criteria:
Inclusion Criteria:
* History of non-specific recurrent LBP with the first onset being at least 6 months ago
* At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
* Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
* During remission the NRS intensity for LBP should be 0.
* LBP should be of that severity that it limits activities of daily living
* LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints
* Flexion pattern of LBP
Exclusion Criteria:
* Chronic LBP (i.e. duration remission \<1 month)
* Subacute LBP (i.e. first onset between 3 and 6 months ago)
* Acute (i.e. first onset \<3 months ago) LBP
* Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy)
* Patients with neuropathic pain
* Patients with chronic widespread pain as defined by the criteria of the 1990 ACR (i.e. fibromyalgia)
* A lifetime history of spinal traumata (e.g. whiplash), surgery (e.g. laminectomy) or deformations (e.g. scoliosis)
* A lifetime history of respiratory, metabolic, neurologic, cardiovascular, inflammatory, orthopedic or rheumatologic diseases
* Concomitant therapies (i.e. rehabilitation, alternative medicine or therapies)
* Contra-indications for MRI (e.g. suffering from claustrophobia, the presence of metallic foreign material in the body, BMI \>30kg/m²)
* Professional athletes
* Pregnant women
* Breastfeeding women
* Women given birth in the last year before enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05706103
Study Brief:
Protocol Section:
NCT05706103