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NCT Number: NCT07576348

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

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.

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Key information

Conditions

Sciatica Bone Diseases Dyssomnias Hernia Insomnia Intervertebral Disc Displacement Lumbar Disc Herniation Mental Disorders Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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;
  • Onset or exacerbation of insomnia temporally associated with the onset or worsening of sciatica symptoms;
  • Willing to participate and able to provide written informed consent.

Exclusion criteria

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

  • 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);
  • Clinically significant depression or anxiety, defined as Patient Health Questionnaire-9 (PHQ-9) ≥ 10 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10;
  • Other primary sleep disorders, including obstructive sleep apnea, narcolepsy, or restless legs syndrome;
  • 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);
  • Irregular sleep patterns, including night shift work (≥ 2 times/week between 22:00-06:00) or highly irregular sleep-wake cycles;
  • Pregnancy or lactation;
  • History of substance abuse or dependence;
  • Lumbar spine surgery or interventional procedures within the past 3 months;
  • History of acupuncture treatment;
  • Implanted electronic devices (e.g., pacemakers) or metal implants at acupuncture sites;
  • Participation in another clinical trial within the past 3 months;
  • Severe sensory or cognitive impairment affecting assessment compliance;
  • Any other condition deemed by investigators to compromise safety or data integrity.

Treatment and study plan

electroacupuncture

Procedure

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.

sham electroacupuncture

Procedure

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).

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) total score

    Time frame: 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 outcomes

  1. Numerical Rating Scale (NRS) score for leg pain intensity

    Time frame: 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.

  2. Numerical Rating Scale (NRS) score for low back pain intensity

    Time frame: 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.

  3. Oswestry Disability Index (ODI) score

    Time frame: 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.

  4. Insomnia Severity Index (ISI) score

    Time frame: 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.

  5. Pittsburgh Sleep Quality Index (PSQI) total score

    Time frame: 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.

  6. Proportion of participants achieving ≥50% reduction in Pittsburgh Sleep Quality Index (PSQI) total score

    Time frame: 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.

  7. Sleep efficiency measured by actigraphy

    Time frame: Baseline, Week 4

  8. Total sleep time measured by actigraphy

    Time frame: Baseline, Week 4

  9. Incidence of adverse events

    Time frame: From baseline to Week 8

Other outcomes

  1. Resting-state electroencephalography-derived microstate parameters

    Time frame: Baseline, Week 4

    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.

  2. Untargeted plasma metabolomic features

    Time frame: Baseline, Week 4

    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.

  3. Credibility/Expectancy Questionnaire scores

    Time frame: Baseline

    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.

  4. Bang blinding index

    Time frame: Week 4

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke Wang

CONTACT

[email protected]

+86 21-65161782-3136

Sponsors and collaborators

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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