Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07809542

Brain Network Characteristics of Pain Patients Based on Magnetoencephalography

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Muscle Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu hospital, Jinan, Shangdong

Jinan, Shandong, 250000, China

Location status: Recruiting

Location contact

Xiangxin Xing

CONTACT

[email protected]

86-18560086949

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for muscle pain as specified in the Clinical Diagnosis Guidelines: Volume of Physical Medicine and Rehabilitation
  • VAS score ≥ 3 points.
  • Aged 18-70 years.
  • Lesions located in the soft tissues of the neck, shoulder, or lumbodorsal region, accompanied by tender points.
  • Able to understand and cooperate in completing the scales and undergoing MEG and MRI examinations.
  • Has signed the informed consent form

Exclusion criteria

  • History of previous related disorders in the neck, shoulder, or lumbodorsal region.
  • Recent use of medications that significantly affect central excitability and inability to stabilize the condition.
  • Contraindications to MEG or MRI.
  • Presence of ferromagnetic metals implanted in the body (e.g., metal dentures, aneurysm clips, pacemakers, stents, steel plates, etc.), claustrophobia that prevents MEG examination, or failed data acquisition.
  • Concurrent severe diseases of the heart, brain, kidney, or other major organs.
  • History of muscle diseases such as tuberculosis, rheumatism, or infection.
  • Obvious cognitive impairment or communication difficulties that prevent cooperation with this study.

Treatment and study plan

magnetoencephalography

Device

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: baseline, pre-intervention

    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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline, pre-intervention

    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

  2. Shoulder Pain and Disability Index (SPADI)

    Time frame: baseline, pre-intervention

    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

  3. Neck Disability Index (NDI)

    Time frame: baseline, pre-intervention

    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

  4. Brain MRI

    Time frame: baseline, pre-intervention

    Uses MRI to evaluate brain structure, used for coregistration with MEG source localization

  5. Oswestry Disability Index (ODI)

    Time frame: baseline, pre-intervention

    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

  6. Central Sensitization Inventory (CSI)

    Time frame: baseline, pre-intervention

    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

  7. American Orthopaedic Foot & Ankle Society (AOFAS)

    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

    baseline, pre-intervention

  8. SF-36 Health Survey

    Time frame: baseline, pre-intervention

    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

  9. nternational Knee Documentation Committee Subjective Knee Form

    Time frame: baseline, pre-intervention

    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

  10. Magnetoencephalography

    Time frame: baseline, pre-intervention

    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

  11. Disabilities of the Arm, Shoulder and Hand Scale

    Time frame: baseline, pre-intervention

    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

  12. Hamilton Anxiety Scale

    Time frame: baseline, pre-intervention

    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

  13. Electroencephalography

    Time frame: baseline, pre-intervention

    Uses scalp electrodes to record brain electrical activity and assess brain function

  14. Hamilton Depression Scale

    Time frame: baseline, pre-intervention

    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

  15. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: baseline, pre-intervention

    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

  16. McGill Pain Questionnaire

    Time frame: baseline, pre-intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofei Zhang

CONTACT

[email protected]

86-15563139097

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.