This is a single-center prospective cohort study. We plan to enroll at least 1,000 patients with muscle pain (VAS ≥ 3) and 200 healthy controls. The study aims to investigate neural oscillatory and functional connectivity characteristics in muscle pain patients using magnetoencephalography (MEG), and to analyze their associations with clinical phenotypes including pain intensity, emotional status, sleep quality, disease duration, and sex. Furthermore, we aim to develop a prognostic model for pain outcome. All pain patients will undergo baseline assessments including MEG (with working-memory task, resting-state, and stimulus-evoked paradigms), brain MRI, and a series of clinical scales (VAS, MPQ, HAMA, HAMD, PSQI, ODI, NDI, SPADI, IKDC, WOMAC, DASH, etc.). They will then be followed up at 1, 3, and 6 months, with repeated collection of pain and functional outcome measures. Multivariate regression, mixed-effects models, and penalized regression will be employed to build prediction models. Model performance will be evaluated using AUC, calibration curves, and bootstrap internal validation. We aim to identify candidate objective neural biomarkers to provide a scientific basis for objective pain assessment and stratified management.
Study Type
OBSERVATIONAL
Enrollment
1,200
MEG is a technique that passively detects weak magnetic field signals generated by intracellular currents in the brain, using superconducting or atomic magnetometers within a magnetically shielded room. By co-registering the MEG signals with MRI for source localization, and performing power spectral analysis across different frequency bands, it enables non-invasive, high temporal-resolution assessment of brain function.
Qilu hospital, Jinan, Shangdong
Jinan, Shandong, China
RECRUITINGVisual Analogue Scale
Uses a 0-10 cm linear scale, with 0 representing no pain and 10 representing the worst imaginable pain; participants mark their current pain level based on subjective feeling
Time frame: baseline, pre-intervention
Pittsburgh Sleep Quality Index (PSQI)
Consists of 19 self-rated items assessing 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction); total score 0-21; higher scores indicate poorer sleep quality
Time frame: baseline, pre-intervention
Shoulder Pain and Disability Index (SPADI)
Consists of two subscales: pain (5 items, 0-10 each, total 0-50) and disability (8 items, 0-10 each, total 0-80), with a total score of 0-130 expressed as a percentage (total/130 × 100%); higher percentages indicate more severe shoulder pain and disability
Time frame: baseline, pre-intervention
Neck Disability Index (NDI)
Consists of 10 items, each scored 0-5, with a total score of 0-50; the score is expressed as a percentage (total/50 × 100%), with higher percentages indicating more severe disability due to neck pain
Time frame: baseline, pre-intervention
Brain MRI
Uses MRI to evaluate brain structure, used for coregistration with MEG source localization
Time frame: baseline, pre-intervention
Oswestry Disability Index (ODI)
Consists of 10 items, each scored 0-5, with a total score of 0-50; the score is expressed as a percentage (total/50 × 100%), with higher percentages indicating more severe disability due to low back pain
Time frame: baseline, pre-intervention
Central Sensitization Inventory (CSI)
Part A consists of 25 items, each scored 0-4, with a total score of 0-100; higher scores indicate more severe central sensitization. Part B records previously diagnosed related syndromes
Time frame: baseline, pre-intervention
American Orthopaedic Foot & Ankle Society (AOFAS)
baseline, pre-intervention
Time frame: Consists of 3 subscales: pain (40 points), function (50 points), and alignment (10 points), with a total score of 0-100; higher scores indicate better ankle-hindfoot function
SF-36 Health Survey
Consists of 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), with each dimension score transformed to a 0-100 scale; higher scores indicate better health status
Time frame: baseline, pre-intervention
nternational Knee Documentation Committee Subjective Knee Form
Covers multiple aspects including knee symptoms, functional activities, and sports ability; total score 0-100, with higher scores indicating better knee function; 90-100 represents normal knee function
Time frame: baseline, pre-intervention
Magnetoencephalography
Uses atomic spin magnetometers in a magnetically shielded room to record spontaneous and task-evoked magnetic signals from the brain, and analyzes neural oscillatory power spectra and functional connectivity as brain network features
Time frame: baseline, pre-intervention
Disabilities of the Arm, Shoulder and Hand Scale
Consists of 30 items, each scored 1-5; the total score is calculated using the formula: (total/30 - 1) × 25, yielding a score range of 0-100; higher scores indicate more severe upper limb disability
Time frame: baseline, pre-intervention
Hamilton Anxiety Scale
Consists of 14 items, each scored 0-4, with a total score of 0-56; higher scores indicate more severe anxiety symptoms; 0-17: mild, 18-24: moderate, ≥25: severe
Time frame: baseline, pre-intervention
Electroencephalography
Uses scalp electrodes to record brain electrical activity and assess brain function
Time frame: baseline, pre-intervention
Hamilton Depression Scale
Consists of 17 items, each scored 0-4, with a total score of 0-52; higher scores indicate more severe depressive symptoms; 0-7: normal/very mild, 8-13: mild, 14-18: moderate, ≥19: severe
Time frame: baseline, pre-intervention
Western Ontario and McMaster Universities Osteoarthritis Index
Consists of 3 subscales: pain (5 items, 0-20), stiffness (2 items, 0-8), and physical function (17 items, 0-68), with a total score of 0-96; higher scores indicate more severe osteoarthritis symptoms
Time frame: baseline, pre-intervention
McGill Pain Questionnaire
Includes pain quality score (20 adjectives, 0-3 each, total 0-78) and pain intensity score (0-5), with a total score of 0-83; higher scores indicate more severe pain
Time frame: baseline, pre-intervention
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