About this trial
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
This trial accepts healthy volunteersQualifiers
18-45 years old
Non-specific low back pain
Duration of pain > 3 months
Positive SLUMP test
Disqualifiers
History of spinal injury
History of cancer
Bone metabolic diseases
Inflammatory conditions (spondyloarthritis or systemic inflammatory diseases)
Trial population
Patients and healthy controls will be recruited through referrals from private physical therapy clinics and medical centers in Thessaloniki, as well as through an open call for expressions of interest to the broader community for voluntary participation.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Power spectral density as measured via OPM-MEG
Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power.
Current density strength of the cortical activity as measured via OPM-MEG
Differences in cortical activity strength between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via an inverse solution algorithm.
Cortical connectivity as measured via OPM-MEG
Differences in cortical connectivity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a connectivity metric estimated from the cortical activity, as reconstructed via an inverse solution algorithm.
Network Topology as measured via OPM-MEG
Differences in network topology between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a graph measure estimated from the connectivity matrices of Outcome 3.
Secondary outcomes
Numerical Rating Pain Scale (NRPS)
Differences in pain intensity between groups and subgroups. This scale assesses subjective pain Intensity by selecting an integer from 0 to 10, where 0 represents complete absence of pain and 10 worst possible pain.
Tampa Scale of Kinesiophobia (TSK)
Differences in kinesiophobia between groups and subgroups. This questionnaire assesses kinesiophobia, i.e. the patient's fear of movement, physical activity, or re-inury due to pain. It includes 17 statements, where each statement is rated on a 4-point Likert scale, from 1 "Strongly disagree" to 4 "Strongly agree". Certain items, such as 4,8,12 and 16 are reversed scored. The total score is derived from the sum of all answers, with higher values indicating greater fear of movement.
Pain Catastrophizing Scale (PCS)
Differences in catastrophizing between groups and subgroups. This questionnaire measures pain catastrophizing i.e. the negative thoughts and excessive emotions experienced by the patient when in pain. It includes 13 statements. The patient rates each statement from 0 "Not at all" to 4 "All the time". The total score ranges from 0 to 52, with higher scores indicating higher levels of catastrophizing.
Athens Insomnia Scale (AIS)
Differences in sleep quality and the likelihood of insomnia between groups and subgroups. This scale assesses sleep quality and the likelihood of insomnia. It consists of 8 questions and each question has 4 response option from 0 "no problem/adequate" to 3 "severe problem/very inadequate". Total scores range from 0 to 24, with higher scores indicating more severe insomnia problems.
Sponsors and contacts
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