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NCT07846163
Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling
Conditions: Chronic Low-back Pain (cLBP)
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Enrollment: 60
Sponsor: Aristotle University Of Thessaloniki
Location: Laboratory of Medical Physics and Digital Innovation, AUTH Thessaloniki Central Macedonia
Summary
This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). The study evaluates brain activity dynamics at rest and during controlled movement-evoked pain. Additionally, it explores the relationship between cortical processing markers and multidimensional biopsychosocial profiles (including pain intensity, kinesiophobia, catastrophizing, sleep quality, and functional disability) and gait adaptaions in adults with CLBP aged 18 to 45 compared to healthy pain-free controls.
Eligibility Criteria
Inclusion Criteria (Group of Chronic Low Back Pain Patients):
* 18-45 years old
* Non-specific low back pain
* Duration of pain \> 3 months
* Positive SLUMP test
Inclusion Criteria (Group of Healthy Control Participants):
* 18-45 years old
* Healthy/ free of pain
Exclusion Criteria (Common for both groups):
* History of spinal injury
* History of cancer
* Bone metabolic diseases
* Inflammatory conditions (spondyloarthritis or systemic inflammatory diseases)
* Spondylolistethis
* Presence of neurological deficits suggesting active nerve root compression/radiculopathy (pathological of tendon reflexes, sensitivity and muscle strength)
* Diagnosed neurodegenerative/neurological disorders or epilepsy
* Psychiatric disorders
* High irritability, according to Severity, Irritability, Nature, Stage, and Stability- SINSS pain assessment tool.
* Claustrophobia due to the measurement process inside the shielded room
* Electrical/electronic implants(e.g. pacemakers), metallic surgical materials (e.g. plates, stent) and dental and orthodontic metallic materials (e.g. braces).
Source: ClinicalTrials.gov (NCT07846163). StuddyBuddy aggregates publicly available trial information.