Dual-Carrier-Frequency Brain Stimulation for Chronic Low Back Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, sham-controlled trial enrolling 60 adults with chronic non-specific low back pain. Participants are assigned to four groups: active dual-carrier-frequency stimulation, active stimulation plus iTBS, superficial stimulation control, and sham control, all combined with standard rehabilitation. Each participant receives 20-minute sessions, five times a week for two weeks (10 sessions total). Primary outcomes focus on pain intensity (VAS) and emotional symptoms (anxiety and depression) at week 2, with exploratory analyses examining brain connectivity using imaging and neurophysiological measures. Secondary outcomes include the McGill Pain Questionnaire, HAMA, HAMD, ODI, CSI, PSQI, and objective brain/EMG/EEG data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 80 years;
2. 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) ;
3. 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;
4. VAS score ≥ 3 (Visual Analogue Scale, 0-10);
5. Mechanical pain induced by posture, activity, and movement (e.g., flexion and functional movement tasks);
6. Voluntarily agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

1. 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.;
2. 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;
3. 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;
4. History of severe cardiovascular disease, epilepsy, or other conditions that contraindicate electrical stimulation;
5. Pregnancy or lactation;
6. Cognitive impairment, psychiatric disorders, or other conditions that prevent understanding or compliance with the study procedures;
7. Rheumatic diseases, connective tissue diseases, or diabetes.

Where it's running

• Qilu hospital, Jinan, Shangdong
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Xiaofei Zhang
• Email: xfeizhang2025@163.com
• Phone: 86-15563139097

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.