Insomnia, Lumbar Disc Herniation, Sciatica
Conditions
Brief summary
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.
Interventions
PROCEDUREElectroacupuncture
Electroacupuncture 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.
PROCEDURESham electroacupuncture
Sham 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).
Sponsors
Shanghai Yueyang Integrated Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) total score | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) score for low back pain intensity | Baseline, Week 4, and Week 8 | 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 | Baseline, Week 4, and Week 8 | 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 | Baseline, Week 2, Week 4, and Week 8 | 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. |
| Pittsburgh Sleep Quality Index (PSQI) total score | Week 8 | 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 | Baseline, Week 2, Week 4, and Week 8 | 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. |
| Sleep efficiency measured by actigraphy | Baseline, Week 4 | — |
| Total sleep time measured by actigraphy | Baseline, Week 4 | — |
| Incidence of adverse events | From baseline to Week 8 | — |
| Proportion of participants achieving ≥50% reduction in Pittsburgh Sleep Quality Index (PSQI) total score | Week 4, Week 8 | 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. |
Contacts
CONTACTKe Wang
Outcome results
None listed