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Muscle PainNCT07809542

Brain Network Characteristics of Pain Patients Based on Magnetoencephalography

An observational study of Muscle Pain, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Pain
What is being tested?
Magnetoencephalography
Type of treatment
Medical device
How many people
1,200 participants
Where
1 siteChina
Study dates
26 May 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaofei Zhang contact

86-15563139097

xfeizhang2025@163.com

China1 site, 1 recruiting

  • Qilu hospital, Jinan, Shangdong

    Jinan, Shandong, 250000

    Xiangxin Xing, 86-18560086949, xingxiangxin123@163.com

    Recruiting

Other trials in China

About this study

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
Being tested
Magnetoencephalography
Medical subject headings
Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagnetoencephalographyDevice

    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.

Study groups in NCT07809542
Study groupRoleWhat they receive
Pain groupThis 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
Receives: Device: Magnetoencephalography
Healthy Control GroupThis 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.
Receives: Device: Magnetoencephalography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, pre-intervention

Secondary outcomes (16)

  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

    Measured: 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

    Measured: 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

    Measured: baseline, pre-intervention

  4. Brain MRI

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

    Measured: baseline, pre-intervention

  5. Oswestry Disability Index (ODI)

    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

    Measured: baseline, pre-intervention

  6. Central Sensitization Inventory (CSI)

    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

    Measured: baseline, pre-intervention

  7. American Orthopaedic Foot & Ankle Society (AOFAS)

    baseline, pre-intervention

    Measured: 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

  8. SF-36 Health Survey

    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

    Measured: baseline, pre-intervention

  9. nternational Knee Documentation Committee Subjective Knee Form

    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

    Measured: baseline, pre-intervention

  10. Magnetoencephalography

    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

    Measured: baseline, pre-intervention

  11. Disabilities of the Arm, Shoulder and Hand Scale

    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

    Measured: baseline, pre-intervention

  12. Hamilton Anxiety Scale

    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

    Measured: baseline, pre-intervention

  13. Electroencephalography

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

    Measured: baseline, pre-intervention

  14. Hamilton Depression Scale

    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

    Measured: baseline, pre-intervention

  15. Western Ontario and McMaster Universities Osteoarthritis Index

    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

    Measured: baseline, pre-intervention

  16. McGill Pain Questionnaire

    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

    Measured: baseline, pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start26 May 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07809542
Sponsor's protocol ID
KYLL-2026-04-089-1
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baillet S. Magnetoencephalography for brain electrophysiology and imaging. Nat Neurosci. 2017 Feb 23;20(3):327-339. doi: 10.1038/nn.4504.

    PubMed 28230841

  • Frokjaer JB, Olesen SS, Graversen C, Andresen T, Lelic D, Drewes AM. Neuroimaging of the human visceral pain system-A methodological review. Scand J Pain. 2018 Jul 1;2(3):95-104. doi: 10.1016/j.sjpain.2011.02.006.

    PubMed 29913746

  • Cavicchioli M, Scalabrini A, Nimbi F, Torelli A, Bottiroli S, Pichiecchio A, Prodi E, Trentini C, Sarzi-Puttini P, Galli F. Fibromyalgia and the painful self: A meta-analysis of resting-state fMRI data. J Psychiatr Res. 2025 Mar;183:61-71. doi: 10.1016/j.jpsychires.2025.01.048. Epub 2025 Jan 30.

    PubMed 39938202

  • 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.

    PubMed 41348694

  • Kim D, Chae Y, Park HJ, Lee IS. Effects of Chronic Pain Treatment on Altered Functional and Metabolic Activities in the Brain: A Systematic Review and Meta-Analysis of Functional Neuroimaging Studies. Front Neurosci. 2021 Jul 5;15:684926. doi: 10.3389/fnins.2021.684926. eCollection 2021.

    PubMed 34290582

  • Phelps CE, Navratilova E, Porreca F. Cognition in the Chronic Pain Experience: Preclinical Insights. Trends Cogn Sci. 2021 May;25(5):365-376. doi: 10.1016/j.tics.2021.01.001. Epub 2021 Jan 25.

    PubMed 33509733

  • 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.

  • Yoshino A, Maekawa T, Kato M, Chan HL, Otsuru N, Yamawaki S. Changes in Resting-State Brain Activity After Cognitive Behavioral Therapy for Chronic Pain: A Magnetoencephalography Study. J Pain. 2024 Aug;25(8):104523. doi: 10.1016/j.jpain.2024.104523. Epub 2024 Apr 4.

    PubMed 38582288

  • Choe MK, Lim M, Kim JS, Lee DS, Chung CK. Disrupted Resting State Network of Fibromyalgia in Theta frequency. Sci Rep. 2018 Feb 1;8(1):2064. doi: 10.1038/s41598-017-18999-z.

    PubMed 29391478

  • Khera T, Rangasamy V. Cognition and Pain: A Review. Front Psychol. 2021 May 21;12:673962. doi: 10.3389/fpsyg.2021.673962. eCollection 2021.

    PubMed 34093370

  • Gopalakrishnan R, Burgess RC, Plow EB, Floden DP, Machado AG. A magnetoencephalography study of multi-modal processing of pain anticipation in primary sensory cortices. Neuroscience. 2015 Sep 24;304:176-89. doi: 10.1016/j.neuroscience.2015.07.049. Epub 2015 Jul 23.

    PubMed 26210576

  • Chertic D, Dabala V, Livint-Popa L, Balea M, Draghici NC, Strilciuc S, Chereches R, Vacaras V, Muresanu DF. EEG Spectral Analysis in Chronic Pain During Rest and Cognitive Reasoning. Sensors (Basel). 2025 Oct 8;25(19):6230. doi: 10.3390/s25196230.

    PubMed 41095052

  • Cohen D. Magnetoencephalography: evidence of magnetic fields produced by alpha-rhythm currents. Science. 1968 Aug 23;161(3843):784-6. doi: 10.1126/science.161.3843.784.

    PubMed 5663803

  • Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.

    PubMed 15979027

  • Bott FS, Zebhauser PT, Hohn VD, Turgut O, May ES, Tiemann L, Gil Avila C, Heitmann H, Nickel MM, Day MA, Adhia DB, Ashar YK, Wager TD, Granovsky Y, Yarnitsky D, Jensen MP, Gross J, Ploner M. Exploring electroencephalographic chronic pain biomarkers: a mega-analysis. EBioMedicine. 2025 Oct;120:105955. doi: 10.1016/j.ebiom.2025.105955. Epub 2025 Sep 30.

    PubMed 41033105

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Pain, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaofei Zhang (86-15563139097, xfeizhang2025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: baseline, pre-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07809542, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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