Brain Network Characteristics of Pain Patients Based on Magnetoencephalography

NCT07809542 | Recruiting

• 1 other identifier: KYLL-2026-04-089-1
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Pain

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, pre-intervention

Secondary Outcomes (16)

• Pittsburgh Sleep Quality Index (PSQI)

  baseline, pre-intervention

• Shoulder Pain and Disability Index (SPADI)

  baseline, pre-intervention

• Neck Disability Index (NDI)

  baseline, pre-intervention

• Brain MRI

  baseline, pre-intervention

• Oswestry Disability Index (ODI)

  baseline, pre-intervention

Study Arms (2)

Pain group

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

Healthy Control Group

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

Interventions

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.

Healthy Control Group; Pain group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital, Jinan, Shangdong

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (18)

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• Witjes B, Starmans MPA, Huygen FJPM, de Vos CC. Classification of chronic pain and spinal cord stimulation response using machine learning in magnetoencephalography data. PLoS One. 2025 Dec 5;20(12):e0337726. doi: 10.1371/journal.pone.0337726. eCollection 2025.

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• SABERI M, VENTRESCA M, ZAMYADI R, et al. Neural synchrony in the pain connectome predicts chronic pain severity and interactions with mental health outcomes: A transdiagnostic study using magnetoencephalography and multivariate modeling [J]. medRxiv, 2024: 2024.11.15.24317356.

  BACKGROUND

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  PMID: 38582288 BACKGROUND

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  PMID: 41095052 BACKGROUND

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MeSH Terms

Conditions

Myalgia

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Central Study Contacts

Xiaofei Zhang

CONTACT

86-15563139097; xfeizhang2025@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: September 9, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)