Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorAristotle University Of Thessaloniki

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: CLBP
Group B: HC

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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