Chronic PainNCT07832188

A Study on the Efficacy of Dual-Carrier-Frequency Transcranial Alternating Current Stimulation Modulating the Hippocampus for the Treatment of Chronic Non-Specific Low Back Pain

A study testing Dual-carrier-frequency transcranial alternating current stimulation and Transcranial electrical stimulation (tES) in people with Chronic Pain, run by Qilu Hospital of Shandong University at 1 site in China.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Pain
What is being tested?: Dual-carrier-frequency transcranial alternating current stimulation and Transcranial electrical stimulation (tES)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: 3 Jul 2026to 24 Sep 2029
Phase: Interventional
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 80 years;
Meets the diagnostic criteria for non-specific low back pain as specified in the Chinese Clinical Guidelines for the Diagnosis and Treatment of Non-specific Low Back Pain (2022) ;
Diagnosed with chronic non-specific low back pain within the past 3 months, or pain located between T12 and the gluteal fold for at least half of the days within the past 6 months;
VAS score ≥ 3 (Visual Analogue Scale, 0-10);
Mechanical pain induced by posture, activity, and movement (e.g., flexion and functional movement tasks);
Voluntarily agrees to participate in this study and has signed the informed consent form.

Who cannot join

Clear etiology of specific low back pain, such as vertebral fracture, severe spinal cord/nerve root compression symptoms (progressive neurological deficit), spinal infection, tumor, ankylosing spondylitis, etc.;
Prior major lumbar surgery or implants (e.g., internal fixation, spinal cord stimulation devices, etc.), or recent (within 3 months) invasive analgesic treatments such as nerve blocks or radiofrequency ablation;
Contraindications to MEG or MRI, including the presence of ferromagnetic metal implants in the body (e.g., cardiac pacemakers, hearing aids, carotid artery stents, etc.), claustrophobia that precludes MEG examination, or failed MEG acquisition;
History of severe cardiovascular disease, epilepsy, or other conditions that contraindicate electrical stimulation;
Pregnancy or lactation;
Cognitive impairment, psychiatric disorders, or other conditions that prevent understanding or compliance with the study procedures;
Rheumatic diseases, connective tissue diseases, or diabetes.

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, randomized, double-blind, sham-controlled trial evaluating dual-carrier-frequency transcranial alternating current stimulation targeting the hippocampus in 60 patients with chronic non-specific low back pain. Participants will be randomized into four groups: active stimulation, active stimulation with iTBS, superficial stimulation control, and sham control. All groups will receive standard rehabilitation. The intervention is 20 minutes per session, 5 sessions weekly for 2 weeks (10 sessions total).

The primary objective is to assess improvements in pain intensity (VAS) and emotional symptoms (anxiety, depression) at week 2. Exploratory objectives include examining functional connectivity changes between the hippocampus and prefrontal/sensory cortices using fMRI, MEG, and fNIRS, and correlating these with clinical improvements.

Outcomes include VAS (primary), McGill Pain Questionnaire, HAMA, HAMD, ODI, CSI, PSQI, and objective measures (brain imaging, EEG, EMG). Assessments occur at baseline (T0), post-first stimulation (T1), mid-treatment (T2), treatment end (T3), and 2-week follow-up (T4).

Linear mixed-effects models will be used for analysis with multiple comparison correction. This study aims to provide evidence for hippocampal-targeted neuromodulation in chronic non-specific low back pain.

Conditions: Chronic Pain
Being tested: Dual-carrier-frequency transcranial alternating current stimulation, Transcranial electrical stimulation (tES)
Medical subject headings: Chronic Pain

What participants receive

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

Dual-carrier-frequency transcranial alternating current stimulationDevice
Also called Temporal interference (TI)
Dual-carrier-frequency transcranial alternating current stimulation is based on the interference principle. Two pairs of carrier-frequency alternating currents with slightly different frequencies are applied to the scalp. After intracranial superposition, the nonlinear response of biological tissues generates a low-frequency envelope-modulated electric field in deep brain regions. This interference electric field oscillates periodically at the difference between the two carrier frequencies, enabling entrainment and modulation of neuronal rhythms in deep structures. This distinguishes it from conventional transcranial electrical stimulation, in which electric field intensity decays exponentially with depth, predominantly affecting superficial cortical layers and having limited efficacy in modulating deep nuclei.
In terms of safety, this technique is a non-invasive stimulation method. Adverse effects are limited to mild tingling or itching at the electrode contact sites, indicating favo
Transcranial electrical stimulation (tES)Device
Cortical electrical stimulation is a neuromodulation technique in which electrodes are placed on the surface of the cerebral cortex or over the dura mater to deliver weak electrical currents for direct modulation of local neuronal electrical activity. By either exciting or inhibiting neuronal firing in specific cortical regions, it can regulate functional brain networks and is commonly used in studies on brain function mapping, neurorehabilitation, and pain modulation.

Study groups in NCT07832188
Study group	Role	What they receive
TI Group	Experimental	Interference currents of 2 kHz and 2.010 kHz are delivered through scalp electrodes to produce a 10 Hz modulation effect in the right hippocampus. The stimulation current is gradually increased from 0.5 mA to 2 mA, and electrode placement is optimized using a head model. A total of 10 sessions are administered (5 sessions per week for 2 weeks), with routine pain rehabilitation performed immediately after each session. Receives: Device: Dual-carrier-frequency transcranial alternating current stimulation
TI-iTBS Group	Active comparator	In addition to the parameters used in the TI group, an intermittent theta-burst stimulation (iTBS) pattern is superimposed. All other parameters, including current intensity, target region, treatment frequency, total course, and subsequent rehabilitation, are identical to those of the TI group. Receives: Device: Dual-carrier-frequency transcranial alternating current stimulation
tES Group	Active comparator	Cortical electrical stimulation is applied, with electrodes primarily placed over the primary somatosensory cortex (S1 region) to activate superficial cortical layers and modulate the sensorimotor network. Stimulation intensity is set within the tolerated range. Each session lasts 20 minutes, and the treatment frequency, total course, and subsequent rehabilitation are consistent with those of the previous two groups. Receives: Device: Transcranial electrical stimulation (tES)
Sham group	Sham comparator	Electrode placement and the operational procedures are identical to those of the TI group. However, the current output during the treatment is 0 mA, with only the onset and offset sensations of stimulation being simulated, and no effective frequency difference or envelope modulation is generated. The treatment course, frequency, and subsequent rehabilitation are the same as those of the other groups, aiming to maintain blinding without producing any neuromodulatory effects. Receives: Device: Dual-carrier-frequency transcranial alternating current stimulation

What is being measured

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

Visual Analogue Scale (VAS)
A 100-mm visual analogue scale is used, with "0" indicating no pain and "10" indicating the worst possible pain; the subject marks the current pain level on the scale, and the distance (mm) from the left end is measured as the VAS score
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Secondary outcomes (13)

Ultrasound
A high-frequency linear array ultrasound probe (≥10 MHz) is placed over the erector spinae and multifidus muscles; cross-sectional and longitudinal gray-scale images are acquired in standardized positions, and muscle thickness, cross-sectional area, and echo intensity are measured using image analysis software to assess morphological and structural changes
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Motion Sensors
Inertial measurement unit (IMU) sensors integrating tri-axial accelerometers, gyroscopes, and magnetometers are attached to the subject's lumbar region and bilateral lower limbs; continuous data on acceleration, angular velocity, and orientation are collected during standardized walking and trunk movement tasks, and gait parameters, trunk range of motion, and symmetry indices are calculated using dedicated algorithms
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Central Sensitization Inventory (CSI)
A 25-item self-administered questionnaire is used, with each item scored from 0 to 4 (never to always); the total score ranges from 0 to 100, with higher scores indicating a higher degree of central sensitization
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Magnetoencephalography (MEG)
A whole-head magnetoencephalography system is used to record spontaneous brain magnetic signals in a shielded room during the resting state; source localization algorithms are applied to reconstruct the magnetic signals from the scalp to the intracerebral source space, and spectral power and functional connectivity of the hippocampus and pain-related brain regions are assessed
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Functional Magnetic Resonance Imaging (fMRI)
Blood oxygen level-dependent (BOLD) functional imaging is performed using a 3.0T or higher MRI scanner; the subject remains in a resting state during scanning, and functional connectivity is assessed by measuring the temporal synchronization of low-frequency BOLD signal oscillations between brain regions, with a focus on connectivity changes between the hippocampus, prefrontal cortex, and somatosensory cortex
Measured: Pre-enrollment (T0),end of the 2-week intervention (T3),
Functional Near-Infrared Spectroscopy (fNIRS)
A multi-channel functional near-infrared spectroscopy system is used, with optodes placed over the scalp regions corresponding to the prefrontal cortex and sensorimotor cortex; changes in oxygenated and deoxygenated hemoglobin concentrations are monitored in real time by measuring near-infrared light attenuation, reflecting regional cerebral functional activity.
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Surface Electromyography (sEMG)
Surface electrodes are placed symmetrically over the bilateral erector spinae and multifidus muscle bellies; sEMG signals are recorded during standardized functional movements (e.g., trunk flexion and extension), and after amplification, filtering and root mean square (RMS) processing, time-domain and frequency-domain parameters are extracted to assess muscle activation patterns and fatigue
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Depression Scale (HAMD)
The 17-item version of the Hamilton Depression Scale is administered by a trained evaluator through a structured interview; the total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Anxiety Scale (HAMA)
The 14-item version of the Hamilton Anxiety Scale is administered by a trained evaluator through a structured interview; the total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
McGill Pain Questionnaire (MPQ)
A standardized self-administered questionnaire comprising sensory, affective, and evaluative dimensions is used; the subject selects the most appropriate pain descriptors based on personal pain experience, and the Pain Rating Index (PRI) and Present Pain Intensity (PPI) scores are calculated
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Oswestry Disability Index (ODI)
A 10-item self-administered questionnaire (covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling) is used; each item is scored 0-5, and the sum is expressed as a percentage of the maximum possible score (0-100%), with higher percentages indicating more severe disability
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Pittsburgh Sleep Quality Index (PSQI)
A 19-item self-administered questionnaire comprising 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) is used; each component is scored 0-3, and the sum yields a global PSQI score (0-21), with a score >5 indicating poor sleep quality
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Electroencephalography (EEG)
Scalp electroencephalography is recorded using the international 10-20 electrode placement system during both resting and task states; signals are amplified, filtered, and digitized, and power spectral density across frequency bands (δ, θ, α, β, γ) and EEG microstate features are extracted to assess changes in spontaneous neural electrical activity
Measured: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Timeline

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

3 Jul 202624 Sep 2029

First posted21 Sep 2026
Study start3 Jul 2026
Primary completion24 Sep 2029 (estimated)
Study completion24 Sep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07832188
Sponsor's protocol ID: KYLL-2026-06-017-1
Status last verified: Jul 2026
First submitted: 21 Jul 2026
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Luo H, Ye X, Cai HT, Wang M, Wang Y, Liu Q, Xu Y, Mao Z, Cai Y, Hong J, Zhang C, Wei P, Lu Y, Liu Q, Xu J, Yuan TF. Frequency-specific and state-dependent neural responses to brain stimulation. Mol Psychiatry. 2025 Jul;30(7):2880-2890. doi: 10.1038/s41380-025-02892-7. Epub 2025 Jan 20.
PubMed 39833357
Esmaeilpour Z, Kronberg G, Reato D, Parra LC, Bikson M. Temporal interference stimulation targets deep brain regions by modulating neural oscillations. Brain Stimul. 2021 Jan-Feb;14(1):55-65. doi: 10.1016/j.brs.2020.11.007. Epub 2020 Nov 11.
PubMed 33186778
Ding M, Xiang S, Zhang Y, Wei L, Weng Y, Zhang X, Ni Y, Zhang Y, Wang Q, Hou R, Du H, Chio KK, Zhang W, Wang H, Jia T, Wu Y, Feng J, Robbins TW, Xiao X. From chronic pain to depression: Neurogenesis-driven microglial remodeling in the hippocampal dentate gyrus. Science. 2026 Mar 19;391(6791):eaee6177. doi: 10.1126/science.aee6177. Epub 2026 Mar 19.
PubMed 41855330
Wang D, Du Z, Wen X, Li Q, Liu Y, Tang J, Shui C, Yu P, Yang L, Tu P, Liu X, Yuan C, Yu D, Ma T, Yuan K. Hippocampal transcranial temporal interference stimulation reduced craving in methamphetamine use disorder. Addict Behav. 2026 Mar;174:108581. doi: 10.1016/j.addbeh.2025.108581. Epub 2025 Dec 11.
PubMed 41389502
Beanato E, Moon HJ, Windel F, Vassiliadis P, Wessel MJ, Popa T, Pauline M, Neufeld E, De Falco E, Gauthier B, Steiner M, Blanke O, Hummel FC. Noninvasive modulation of the hippocampal-entorhinal complex during spatial navigation in humans. Sci Adv. 2024 Nov;10(44):eado4103. doi: 10.1126/sciadv.ado4103. Epub 2024 Oct 30.
PubMed 39475597
Lamos M, Bockova M, Missey F, Lubrano C, de Araujo E Silva M, Trajlinek J, Studnicka O, Daniel P, Carron R, Jirsa V, Chrastina J, Jancalek R, Glowacki ED, Cassara A, Neufeld E, Rektorova I, Williamson A. Noninvasive Temporal Interference Stimulation of the Subthalamic Nucleus in Parkinson's Disease Reduces Beta Activity. Mov Disord. 2025 Jun;40(6):1051-1060. doi: 10.1002/mds.30134. Epub 2025 Apr 9.
PubMed 40202094
Vassiliadis P, Beanato E, Popa T, Windel F, Morishita T, Neufeld E, Duque J, Derosiere G, Wessel MJ, Hummel FC. Non-invasive stimulation of the human striatum disrupts reinforcement learning of motor skills. Nat Hum Behav. 2024 Aug;8(8):1581-1598. doi: 10.1038/s41562-024-01901-z. Epub 2024 May 29.
PubMed 38811696
Ma R, Xia X, Zhang W, Lu Z, Wu Q, Cui J, Song H, Fan C, Chen X, Zha R, Wei J, Ji GJ, Wang X, Qiu B, Zhang X. High Gamma and Beta Temporal Interference Stimulation in the Human Motor Cortex Improves Motor Functions. Front Neurosci. 2022 Jan 3;15:800436. doi: 10.3389/fnins.2021.800436. eCollection 2021.
PubMed 35046771
Demchenko I, Tailor I, Chegini S, Yu H, Gholamali Nezhad F, Rueda A, Kever A, Krishnan S, Datta A, Meltzer JA, Graham SJ, Schweizer TA, Rampersad S, Boyden ES, Violante IR, Chen R, Lozano AM, Bhat V. Human Applications of Transcranial Temporal Interference Stimulation: A Systematic Review. medRxiv [Preprint]. 2025 Sep 23:2025.05.16.25327804. doi: 10.1101/2025.05.16.25327804.
PubMed 40463528
Rampersad S, Roig-Solvas B, Yarossi M, Kulkarni PP, Santarnecchi E, Dorval AD, Brooks DH. Prospects for transcranial temporal interference stimulation in humans: A computational study. Neuroimage. 2019 Nov 15;202:116124. doi: 10.1016/j.neuroimage.2019.116124. Epub 2019 Aug 29.
PubMed 31473351
Vachon-Presseau E, Roy M, Martel MO, Caron E, Marin MF, Chen J, Albouy G, Plante I, Sullivan MJ, Lupien SJ, Rainville P. The stress model of chronic pain: evidence from basal cortisol and hippocampal structure and function in humans. Brain. 2013 Mar;136(Pt 3):815-27. doi: 10.1093/brain/aws371.
PubMed 23436504
Duric V, McCarson KE. Persistent pain produces stress-like alterations in hippocampal neurogenesis and gene expression. J Pain. 2006 Aug;7(8):544-55. doi: 10.1016/j.jpain.2006.01.458.
PubMed 16885011
Zhang J, Zheng X, Zhang G, Cheng Z, Liu Y, Zhang L, Zhang J, Liu X, Yang Z. Chronic postoperative pain induces contextual fear extinction dysfunction through hippocampal NMDAR/BDNF/TrkB signaling pathway in mice. Transl Psychiatry. 2025 Jun 17;15(1):203. doi: 10.1038/s41398-025-03417-0.
PubMed 40527933
Perry Caleb, Heathcote Lauren, Thomas Kayla, et al. The role of hippocampus and amygdala morphology in memory bias of learned fear in youth with chronic pain[J]. The Journal of Pain, 2021, 22(5): 604.
Berger SE, Vachon-Presseau E, Abdullah TB, Baria AT, Schnitzer TJ, Apkarian AV. Hippocampal morphology mediates biased memories of chronic pain. Neuroimage. 2018 Feb 1;166:86-98. doi: 10.1016/j.neuroimage.2017.10.030. Epub 2017 Nov 6.
PubMed 29080714

Interested in taking part?

Xiaofei Zhang

86-15563139097

xfeizhang2025@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Efficacy of Dual-Carrier-Frequency Transcranial Alternating Current Stimulation Modulating the Hippocampus for the Treatment of Chronic Non-Specific Low Back Pain
ClinicalTrials.gov ID: NCT07832188
Acronym / sponsor ID: KYLL-2026-06-017-1
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Qilu Hospital of Shandong UniversityUniversity, hospital or other
Study start: 3 Jul 2026 (actual)
Primary completion: 24 Sep 2029 (estimated)
Study completion: 24 Sep 2029 (estimated)
First posted: 21 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TI Group	Experimental	Device: Dual-carrier-frequency transcranial alternating current stimulationInterference currents of 2 kHz and 2.010 kHz are delivered through scalp electrodes to produce a 10 Hz modulation effect in the right hippocampus. The stimulation current is gradually increased from 0.5 mA to 2 mA, and electrode placement is optimized using a head model. A total of 10 sessions are administered (5 sessions per week for 2 weeks), with routine pain rehabilitation performed immediately after each session.
TI-iTBS Group	Active comparator	Device: Dual-carrier-frequency transcranial alternating current stimulationIn addition to the parameters used in the TI group, an intermittent theta-burst stimulation (iTBS) pattern is superimposed. All other parameters, including current intensity, target region, treatment frequency, total course, and subsequent rehabilitation, are identical to those of the TI group.
tES Group	Active comparator	Device: Transcranial electrical stimulation (tES)Cortical electrical stimulation is applied, with electrodes primarily placed over the primary somatosensory cortex (S1 region) to activate superficial cortical layers and modulate the sensorimotor network. Stimulation intensity is set within the tolerated range. Each session lasts 20 minutes, and the treatment frequency, total course, and subsequent rehabilitation are consistent with those of the previous two groups.
Sham group	Sham comparator	Device: Dual-carrier-frequency transcranial alternating current stimulationElectrode placement and the operational procedures are identical to those of the TI group. However, the current output during the treatment is 0 mA, with only the onset and offset sensations of stimulation being simulated, and no effective frequency difference or envelope modulation is generated. The treatment course, frequency, and subsequent rehabilitation are the same as those of the other groups, aiming to maintain blinding without producing any neuromodulatory effects.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age between 18 and 80 years;
Meets the diagnostic criteria for non-specific low back pain as specified in the Chinese Clinical Guidelines for the Diagnosis and Treatment of Non-specific Low Back Pain (2022) ;
Diagnosed with chronic non-specific low back pain within the past 3 months, or pain located between T12 and the gluteal fold for at least half of the days within the past 6 months;
VAS score ≥ 3 (Visual Analogue Scale, 0-10);
Mechanical pain induced by posture, activity, and movement (e.g., flexion and functional movement tasks);

Key exclusion criteria (7 listed)

Clear etiology of specific low back pain, such as vertebral fracture, severe spinal cord/nerve root compression symptoms (progressive neurological deficit), spinal infection, tumor, ankylosing spondylitis, etc.;
Prior major lumbar surgery or implants (e.g., internal fixation, spinal cord stimulation devices, etc.), or recent (within 3 months) invasive analgesic treatments such as nerve blocks or radiofrequency ablation;
Contraindications to MEG or MRI, including the presence of ferromagnetic metal implants in the body (e.g., cardiac pacemakers, hearing aids, carotid artery stents, etc.), claustrophobia that precludes MEG examination, or failed MEG acquisition;
History of severe cardiovascular disease, epilepsy, or other conditions that contraindicate electrical stimulation;
Pregnancy or lactation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual-carrier-frequency transcranial alternating current stimulationAlso: Temporal interference (TI)Dual-carrier-frequency transcranial alternating current stimulation is based on the interference principle. Two pairs of carrier-frequency alternating currents with slightly different frequencies are applied to the scalp. After intracranial superposition, the nonlinear response of biological tissues generates a low-frequency envelope-modulated electric field in deep brain regions. This interference electric field oscillates periodically at the difference between the two carrier frequencies, enabling entrainment and modulation of neuronal rhythms in deep structures. This distinguishes it from conventional transcranial electrical stimulation, in which electric field intensity decays exponentially with depth, predominantly affecting superficial cortical layers and having limited efficacy in modulating deep nuclei. In terms of safety, this technique is a non-invasive stimulation method. Adverse effects are limited to mild tingling or itching at the electrode contact sites, indicating favo	Device	Sham group, TI Group, TI-iTBS Group
Transcranial electrical stimulation (tES)Cortical electrical stimulation is a neuromodulation technique in which electrodes are placed on the surface of the cerebral cortex or over the dura mater to deliver weak electrical currents for direct modulation of local neuronal electrical activity. By either exciting or inhibiting neuronal firing in specific cortical regions, it can regulate functional brain networks and is commonly used in studies on brain function mapping, neurorehabilitation, and pain modulation.	Device	tES Group

Primary outcome

Visual Analogue Scale (VAS)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
A 100-mm visual analogue scale is used, with "0" indicating no pain and "10" indicating the worst possible pain; the subject marks the current pain level on the scale, and the distance (mm) from the left end is measured as the VAS score

13 secondary outcomes

Ultrasound
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Motion Sensors
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Central Sensitization Inventory (CSI)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Magnetoencephalography (MEG)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Pre-enrollment (T0),end of the 2-week intervention (T3),
Functional Near-Infrared Spectroscopy (fNIRS)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Surface Electromyography (sEMG)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Depression Scale (HAMD)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Anxiety Scale (HAMA)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
McGill Pain Questionnaire (MPQ)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Oswestry Disability Index (ODI)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Electroencephalography (EEG)
Time frame: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Background: PubMed 39833357Luo H, Ye X, Cai HT, Wang M, Wang Y, Liu Q, Xu Y, Mao Z, Cai Y, Hong J, Zhang C, Wei P, Lu Y, Liu Q, Xu J, Yuan TF. Frequency-specific and state-dependent neural responses to brain stimulation. Mol Psychiatry. 2025 Jul;30(7):2880-2890. doi: 10.1038/s41380-025-02892-7. Epub 2025 Jan 20.
Background: PubMed 33186778Esmaeilpour Z, Kronberg G, Reato D, Parra LC, Bikson M. Temporal interference stimulation targets deep brain regions by modulating neural oscillations. Brain Stimul. 2021 Jan-Feb;14(1):55-65. doi: 10.1016/j.brs.2020.11.007. Epub 2020 Nov 11.
Background: PubMed 41855330Ding M, Xiang S, Zhang Y, Wei L, Weng Y, Zhang X, Ni Y, Zhang Y, Wang Q, Hou R, Du H, Chio KK, Zhang W, Wang H, Jia T, Wu Y, Feng J, Robbins TW, Xiao X. From chronic pain to depression: Neurogenesis-driven microglial remodeling in the hippocampal dentate gyrus. Science. 2026 Mar 19;391(6791):eaee6177. doi: 10.1126/science.aee6177. Epub 2026 Mar 19.
Background: PubMed 41389502Wang D, Du Z, Wen X, Li Q, Liu Y, Tang J, Shui C, Yu P, Yang L, Tu P, Liu X, Yuan C, Yu D, Ma T, Yuan K. Hippocampal transcranial temporal interference stimulation reduced craving in methamphetamine use disorder. Addict Behav. 2026 Mar;174:108581. doi: 10.1016/j.addbeh.2025.108581. Epub 2025 Dec 11.
Background: PubMed 39475597Beanato E, Moon HJ, Windel F, Vassiliadis P, Wessel MJ, Popa T, Pauline M, Neufeld E, De Falco E, Gauthier B, Steiner M, Blanke O, Hummel FC. Noninvasive modulation of the hippocampal-entorhinal complex during spatial navigation in humans. Sci Adv. 2024 Nov;10(44):eado4103. doi: 10.1126/sciadv.ado4103. Epub 2024 Oct 30.
Background: PubMed 40202094Lamos M, Bockova M, Missey F, Lubrano C, de Araujo E Silva M, Trajlinek J, Studnicka O, Daniel P, Carron R, Jirsa V, Chrastina J, Jancalek R, Glowacki ED, Cassara A, Neufeld E, Rektorova I, Williamson A. Noninvasive Temporal Interference Stimulation of the Subthalamic Nucleus in Parkinson's Disease Reduces Beta Activity. Mov Disord. 2025 Jun;40(6):1051-1060. doi: 10.1002/mds.30134. Epub 2025 Apr 9.
Background: PubMed 38811696Vassiliadis P, Beanato E, Popa T, Windel F, Morishita T, Neufeld E, Duque J, Derosiere G, Wessel MJ, Hummel FC. Non-invasive stimulation of the human striatum disrupts reinforcement learning of motor skills. Nat Hum Behav. 2024 Aug;8(8):1581-1598. doi: 10.1038/s41562-024-01901-z. Epub 2024 May 29.
Background: PubMed 35046771Ma R, Xia X, Zhang W, Lu Z, Wu Q, Cui J, Song H, Fan C, Chen X, Zha R, Wei J, Ji GJ, Wang X, Qiu B, Zhang X. High Gamma and Beta Temporal Interference Stimulation in the Human Motor Cortex Improves Motor Functions. Front Neurosci. 2022 Jan 3;15:800436. doi: 10.3389/fnins.2021.800436. eCollection 2021.
Background: PubMed 40463528Demchenko I, Tailor I, Chegini S, Yu H, Gholamali Nezhad F, Rueda A, Kever A, Krishnan S, Datta A, Meltzer JA, Graham SJ, Schweizer TA, Rampersad S, Boyden ES, Violante IR, Chen R, Lozano AM, Bhat V. Human Applications of Transcranial Temporal Interference Stimulation: A Systematic Review. medRxiv [Preprint]. 2025 Sep 23:2025.05.16.25327804. doi: 10.1101/2025.05.16.25327804.
Background: PubMed 31473351Rampersad S, Roig-Solvas B, Yarossi M, Kulkarni PP, Santarnecchi E, Dorval AD, Brooks DH. Prospects for transcranial temporal interference stimulation in humans: A computational study. Neuroimage. 2019 Nov 15;202:116124. doi: 10.1016/j.neuroimage.2019.116124. Epub 2019 Aug 29.
Background: PubMed 23436504Vachon-Presseau E, Roy M, Martel MO, Caron E, Marin MF, Chen J, Albouy G, Plante I, Sullivan MJ, Lupien SJ, Rainville P. The stress model of chronic pain: evidence from basal cortisol and hippocampal structure and function in humans. Brain. 2013 Mar;136(Pt 3):815-27. doi: 10.1093/brain/aws371.
Background: PubMed 16885011Duric V, McCarson KE. Persistent pain produces stress-like alterations in hippocampal neurogenesis and gene expression. J Pain. 2006 Aug;7(8):544-55. doi: 10.1016/j.jpain.2006.01.458.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xiaofei Zhang contact

86-15563139097

xfeizhang2025@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 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. Some participants in this study may receive a placebo. 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 (VAS) (time frame: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)). 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 NCT07832188, which also lists 25 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 21 Sep 2026.