Exploring Pain: An OPM-MEG, Biomechanical, and Biopsychosocial Analysis in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Power spectral density as measured via OPM-MEG
研究概览
简要总结
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.
详细描述
Chronic low back pain (CLBP) is a leading healthcare challenge, with a significant proportion of cases classified as non-specific (NSLBP). A distinct subset of CLBP patients presents with neural mechanosensitivity, often clinically confirmed via neurodynamic tests such as the Slump test. While traditional neuroimaging has advanced our understanding of pain processing, conventional methods like EEG lack spatial resolution for deep brain structures, and traditional SQUID-MEG systems severely restrict patient movement.
This study leverages the novel technology of wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG), allowing for non-invasive, high-resolution recording of brain activity during movement.
The study protocol involves screening for eligibility, comprehensive demographic and medical history collection, and a physical/neurological examination (including reflex, sensory, and muscle strength testing, alongside Straight Leg Raise and Slump tests). Participants complete validated psychometric questionnaires evaluating pain intensity, kinesiophobia, pain catastrophizing , sleep quality, functional disability, and quality of life. Furthermore, participants undergo a standardized 6-minute walk test using smart digital insoles to record spatiotemporal parameters, kinematic variables, and composite gait biomarkers.
Participants, also, perform a controlled, movement-evoked pain task (modified Slump-based knee extension/flexion protocol) designed to elicit mild, transient symptoms and a resting state recording.
The primary objectives are to map and compare resting-state and movement-evoked cortical oscillations, current density, and functional connectivity between CLBP patients and healthy controls, and to assess the predictive value of neurophysiological markers on psychological burden. Secondary objectives include identifying distinct pain phenotypes by integrating biomechanical, psychophysiological, and neural data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •(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).
研究组 & 干预措施
CLBP
Adults aged 18-45 with chronic low back pain (>3 months) and neural mechanosensitivity.
HC
Healthy volunteers without pain.
结局指标
主要结局
Power spectral density as measured via OPM-MEG
时间窗: Baseline
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
时间窗: Baseline
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
时间窗: Baseline
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
时间窗: Baseline
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.
次要结局
- Numerical Rating Pain Scale (NRPS)(Baseline)
- Tampa Scale of Kinesiophobia (TSK)(Baseline)
- Pain Catastrophizing Scale (PCS)(Baseline)
- Athens Insomnia Scale (AIS)(Baseline)
- Functional Disability measured via Modified Oswestry Disability Index (ODI)(Baseline)
- Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)(Baseline)
- Distance walked during the 6-Minutes Walking Test (6-MWT)(Baseline)
- Average Walking Speed (km/h)(Baseline)
- Cadence (step/min)(Baseline)
- Stride Length (cm)(Baseline)
- Stance Time (ms and %)(Baseline)
- Swing Time (ms and %)(Baseline)
- Double Support Time (%).(Baseline)
- Symmetry Percentages (%) between the lower limbs(Baseline)
研究者
Panos Bamidis
Professor
Aristotle University Of Thessaloniki