NCT07809542 Brain Network Characteristics of Pain Patients Based on Magnetoencephalography
| NCT ID | NCT07809542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Muscle Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2026-05-26 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07809542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Muscle Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07809542 currently recruiting?
Yes, NCT07809542 is actively recruiting participants. Contact the research team at xfeizhang2025@163.com for enrollment information.
Where is the NCT07809542 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07809542 clinical trial?
NCT07809542 is sponsored by Qilu Hospital of Shandong University. The trial plans to enroll 1,200 participants.