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

NCT07576348 | Not Yet Recruiting

• 1 other identifier: 2026-084
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sciatica; Lumbar Disc Herniation; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (9)

• Numerical Rating Scale (NRS) score for leg pain intensity

  Baseline, Week 2, Week 4, and Week 8

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

  Baseline, Week 4, and Week 8

• Oswestry Disability Index (ODI) score

  Baseline, Week 4, and Week 8

• Insomnia Severity Index (ISI) score

  Baseline, Week 2, Week 4, and Week 8

• Pittsburgh Sleep Quality Index (PSQI) total score

  Week 8

Other Outcomes (4)

• Resting-state electroencephalography-derived microstate parameters

  Baseline, Week 4

• Untargeted plasma metabolomic features

  Baseline, Week 4

• Credibility/Expectancy Questionnaire scores

  Baseline

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

Procedure: Electroacupuncture

Sham electroacupuncture

SHAM COMPARATOR

Procedure: Sham electroacupuncture

Interventions

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.

Electroacupuncture

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).

Sham electroacupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

MeSH Terms

Conditions

Sciatica; Intervertebral Disc Displacement; Sleep Initiation and Maintenance Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Ke Wang

CONTACT

+86 21-65161782-3136; wangke8430@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05