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Brain network characteristics of pain patients based on magnetoencephalography

NCT ID NCT07809542

NEW Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meet the diagnostic criteria for muscle pain as specified in the Clinical Diagnosis Guidelines: Volume of Physical Medicine and Rehabilitation 2. VAS score ≥ 3 points. 3. Aged 18-70 years. 4. Lesions located in the soft tissues of the neck, shoulder, or lumbodorsal region, accompanied by tender points. 5. Able to understand and cooperate in completing the scales and undergoing MEG and MRI examinations. 6. Has signed the informed consent form Exclusion Criteria: 1. History of previous related disorders in the neck, shoulder, or lumbodorsal region. 2. Recent use of medications that significantly affect central excitability and inability to stabilize the condition. 3. Contraindications to MEG or MRI. 4. 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. 5. Concurrent severe diseases of the heart, brain, kidney, or other major organs. 6. History of muscle diseases such as tuberculosis, rheumatism, or infection. 7. Obvious cognitive impairment or communication difficulties that prevent cooperation with this study.

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Conditions

The condition(s) this trial relates to.

Myalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscle pain

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Qilu hospital, Jinan, Shangdong

    RECRUITING

    Jinan, Shandong, 250000, China

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