An observational study in Muscle Pain, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
256 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 196 across 35 observational studies indexed under Myalgia.
Browse Myalgia studies →Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pain patients constitute the core longitudinal follow-up cohort of this study. Their role is to provide baseline MEG brain network features and clinical data for model training, and to supply longitudinal outcome data through follow-up visits, which will be used to establish a prognostic model for pain outcomes and to screen for candidate objective neural biomarkers.
Healthy controls serve as a baseline reference group and do not participate in longitudinal follow-up. Their role is to establish normative reference features of brain networks in healthy individuals, providing a normal benchmark for assessing the degree of abnormality in pain patients.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a prospective cohort that continuously enrolls pain patients aged 18-70 years who meet the diagnostic criteria for muscle pain, have a VAS score ≥3, and present with lesions in the soft tissues of the neck, shoulders, or low back accompanied by tender points. Patients with a history of previous cervical, shoulder, or lumbar disorders, those taking medications that significantly affect central nervous system excitability with unstable disease control, those with contraindications to MEG/MRI, those with severe systemic diseases, and those with cognitive or communication impairments are excluded. After undergoing baseline MEG, MRI, and multi-dimensional scale assessments, participants receive routine clinical treatment according to standard care pathways (the study does not impose any additional intervention), and are followed up regularly via telephone or electronic means. Treatment exposure and outcome changes are dynamically documented throughout follow-up, and the collected d
Device: Magnetoencephalography
This group serves as a baseline reference cohort, comprising healthy volunteers aged 18-70 years without metallic implants in the head or neck region. After signing informed consent, participants complete a single baseline assessment consisting of MEG, MRI, and health questionnaire evaluations. No intervention is administered, and participants are not included in the longitudinal follow-up. Data from this group are used to establish reference characteristics of brain networks in healthy individuals, providing a baseline comparative standard for assessing the degree of brain network abnormalities in the pain group.
Device: Magnetoencephalography
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.
Visual 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
PDFs hosted by the registry, ClinicalTrials.gov.
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