Health TrialsbyHealthPanel

Brain Network Characteristics of Pain Patients Based on Magnetoencephalography

ConditionMuscle Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Pain group1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

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

Time frame
baseline, pre-intervention

Secondary outcomes

1

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
2

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
3

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
4

Brain MRI

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

Time frame
baseline, pre-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov
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