Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial

Inclusion Criteria:

Participants will be eligible if they meet all of the following criteria:

1. Aged 18-75 years, of either sex;
2. Diagnosis with lumbar disc herniation accompanied by unilateral chronic sciatica (disease duration ≥ 3 months);
3. 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;
4. Diagnosis of chronic insomnia, with a Pittsburgh Sleep Quality Index (PSQI) total score > 7;
5. Onset or exacerbation of insomnia temporally associated with the onset or worsening of sciatica symptoms;
6. Willing to participate and able to provide written informed consent.

Exclusion Criteria:

Participants will be excluded if any of the following criteria are met:

1. Spinal or structural conditions: lumbar spinal stenosis, spondylolisthesis, vertebral fracture, spinal infection (e.g., tuberculosis), or tumor;
2. Surgical indications: cauda equina syndrome, conus medullaris syndrome, or other conditions requiring urgent surgical intervention;
3. 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);
4. Neurological or psychiatric disorders: major neurological diseases (e.g., epilepsy, Parkinson's disease, dementia, multiple sclerosis) or severe psychiatric disorders (e.g., schizophrenia);
5. Clinically significant depression or anxiety, defined as Patient Health Questionnaire-9 (PHQ-9) ≥ 10 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10;
6. Other primary sleep disorders, including obstructive sleep apnea, narcolepsy, or restless legs syndrome;
7. Use of centrally acting medications: regular use (≥ 3 days/week within 4 weeks prior to enrolment) of medications affecting the central nervous system (e.g., opioids, sedative-hypnotics, antidepressants) without an adequate washout period (≥ 2 weeks or longer depending on drug half-life);
8. Irregular sleep patterns, including night shift work (≥ 2 times/week between 22:00-06:00) or highly irregular sleep-wake cycles;
9. Pregnancy or lactation;
10. History of substance abuse or dependence;
11. Lumbar spine surgery or interventional procedures within the past 3 months;
12. History of acupuncture treatment;
13. Implanted electronic devices (e.g., pacemakers) or metal implants at acupuncture sites;
14. Participation in another clinical trial within the past 3 months;
15. Severe sensory or cognitive impairment affecting assessment compliance;
16. Any other condition deemed by investigators to compromise safety or data integrity.