The goal of this clinical trial is to learn if electroacupuncture can improve sleep in people with chronic sciatica caused by lumbar disc herniation. It will also assess the safety of this treatment. The main questions it aims to answer are whether electroacupuncture improves sleep quality and whether it reduces pain and improves daily function. Researchers will compare electroacupuncture to a sham treatment, which looks like real acupuncture but has little or no therapeutic effect, to determine its effectiveness. Participants will be randomly assigned to receive electroacupuncture or sham treatment, will receive treatment three times per week for four weeks, and will complete questionnaires about their sleep, pain, and daily activities.
Aged 18-75 years, of either sex;
Diagnosis with lumbar disc herniation accompanied by unilateral chronic sciatica (disease duration ≥ 3 months);
Experiencing moderate to severe radiating leg pain (below the knee), defined as a Numerical Rating Scale (NRS) score ≥ 4 at screening within the past 24 h;
Diagnosis of chronic insomnia, with a Pittsburgh Sleep Quality Index (PSQI) total score > 7;
Spinal or structural conditions: lumbar spinal stenosis, spondylolisthesis, vertebral fracture, spinal infection (e.g., tuberculosis), or tumor;
Surgical indications: cauda equina syndrome, conus medullaris syndrome, or other conditions requiring urgent surgical intervention;
Severe systemic diseases: unstable cardiovascular, hepatic, renal, respiratory, or hematological disorders, or metabolic conditions that may significantly affect study outcomes (e.g., uncontrolled diabetes or thyroid disease);
Neurological or psychiatric disorders: major neurological diseases (e.g., epilepsy, Parkinson's disease, dementia, multiple sclerosis) or severe psychiatric disorders (e.g., schizophrenia);
Parallel
Electroacupuncture
Procedure/SurgeryElectroacupuncture will be administered by a licensed acupuncturist. Adhesive foam pads will be applied at each acupoint to enhance blinding. Sterile needles will be inserted through the pads into the skin at predefined acupoints, including Sishencong (EX-HN1), bilateral Shenmen (HT7) and Sanyinjiao (SP6), Jiaji (EX-B2) at the L3-L5 levels (bilateral points at each segment), Shenshu (BL23), Dachangshu (BL25), and selected lower limb acupoints. Electrical stimulation will be applied using a sparse-dense wave (2/10 Hz) for 30 minutes per session. Treatment will be delivered three times per week for four weeks.
Sham electroacupuncture
Procedure/SurgerySham electroacupuncture will be administered by a licensed acupuncturist. Adhesive foam pads will be applied at each non-acupoint to maintain blinding. Sterile needles will be inserted superficially (2-3 mm) through the pads without manipulation or eliciting deqi sensation. Electrical stimulation will be minimally applied only briefly at the beginning and end of each session to mimic the procedure. Treatment duration and frequency will be identical to the electroacupuncture group (30 minutes per session, three times per week for four weeks).
Pittsburgh Sleep Quality Index (PSQI) total score
The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported instrument designed to assess sleep quality over the preceding month, with total scores ranging from 0 to 21, where higher scores denote poorer sleep quality.
Numerical Rating Scale (NRS) score for leg pain intensity
The 11-point Numerical Rating Scale (NRS) is a self-reported instrument used to assess average radiating leg pain intensity over the preceding 24 hours, with scores ranging from 0 to 10, where higher scores denote more severe pain.
Numerical Rating Scale (NRS) score for low back pain intensity
The 11-point Numerical Rating Scale (NRS) is a self-reported instrument used to assess average low back pain intensity over the preceding 24 hours, with scores ranging from 0 to 10, where higher scores denote more severe pain.
Oswestry Disability Index (ODI) score
The Oswestry Disability Index (ODI) is a self-reported questionnaire used to assess disability related to lumbar spine disorders, with percentage scores ranging from 0% to 100%, where higher scores denote greater disability.
Insomnia Severity Index (ISI) score
The Insomnia Severity Index (ISI) is a self-reported instrument used to assess the subjective severity of insomnia, its impact on daytime functioning, and associated distress over the preceding two weeks, with total scores ranging from 0 to 28, where higher scores denote more severe insomnia.
Resting-state electroencephalography-derived microstate parameters
Resting-state electroencephalography-derived microstate parameters, including mean duration, occurrence rate, time coverage, and transition probability, will be assessed at baseline and week 4. Mean duration refers to the average time for which a microstate class remains stable; occurrence rate refers to the number of occurrences per second; time coverage refers to the percentage of total recording time occupied by a microstate class; and transition probability refers to the probability of transition from one microstate class to another.
Untargeted plasma metabolomic features
Fasting plasma samples will be collected at baseline and week 4 and analyzed using an untargeted metabolomics approach based on ultra-high-performance liquid chromatography-high-resolution mass spectrometry (UHPLC-HRMS). Detected metabolomic features will be characterized by mass-to-charge ratio, retention time, relative ion intensity, and tandem mass spectrometry spectra.
Credibility/Expectancy Questionnaire scores
Treatment credibility and expectancy will be assessed before treatment using the Credibility/Expectancy Questionnaire. The credibility subscale consists of three items rated on a 1-9 scale, with a total score ranging from 3 to 27; higher scores indicate greater perceived treatment credibility. The expectancy subscale consists of three items assessing expected improvement and perceived treatment benefit. Two items are rated from 0% to 100%, and one item rated on a 1-9 scale will be transformed to a 0-100 scale; the three items will be averaged to generate a score ranging from 0 to 100, with higher scores indicating greater treatment expectancy.
Bang blinding index
At week 4, before unblinding, participants will complete a structured blinding assessment question asking them to guess their treatment allocation as real electroacupuncture, sham electroacupuncture, or "uncertain." Blinding success will be quantified using the Bang blinding index and its 95% confidence interval. The Bang blinding index ranges from -1 to 1, with values close to 0 indicating successful blinding. Values between -0.2 and 0.2 will be interpreted as indicating adequate blinding.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
