SciaticaNCT07576348
Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial
A study testing Electroacupuncture in people with Sciatica and Lumbar Disc Herniation, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sciatica, Lumbar Disc Herniation, Insomnia
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Medical subject headings
- Sciatica, Intervertebral Disc Displacement, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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 electroacupunctureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Not described Receives: Procedure: Electroacupuncture |
| Sham electroacupuncture | Sham comparator | Not described Receives: Procedure: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (9)
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.
Measured: Baseline, Week 2, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 2, Week 4, and Week 8
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.
Measured: Week 8
Proportion of participants achieving ≥50% reduction in 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.
Measured: Week 4, Week 8
Sleep efficiency measured by actigraphy
Measured: Baseline, Week 4
Total sleep time measured by actigraphy
Measured: Baseline, Week 4
Incidence of adverse events
Measured: From baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startMay 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576348
- Sponsor's protocol ID
- 2026-084
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07576348
- Acronym / sponsor ID
- 2026-084
- Conditions
- Sciatica, Lumbar Disc Herniation, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Procedure: Electroacupuncture |
| Sham electroacupuncture | Sham comparator | Procedure: Sham electroacupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture 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. | Procedure or surgery | Electroacupuncture |
| Sham electroacupunctureSham 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). | Procedure or surgery | Sham electroacupuncture |
Primary outcome
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.
9 secondary outcomes
Numerical Rating Scale (NRS) score for leg pain intensity
Time frame: Baseline, Week 2, Week 4, and Week 8
Numerical Rating Scale (NRS) score for low back pain intensity
Time frame: Baseline, Week 4, and Week 8
Oswestry Disability Index (ODI) score
Time frame: Baseline, Week 4, and Week 8
Insomnia Severity Index (ISI) score
Time frame: Baseline, Week 2, Week 4, and Week 8
Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Week 8
Proportion of participants achieving ≥50% reduction in Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Week 4, Week 8
Sleep efficiency measured by actigraphy
Time frame: Baseline, Week 4
Total sleep time measured by actigraphy
Time frame: Baseline, Week 4
Incidence of adverse events
Time frame: From baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Sciatica and Lumbar Disc Herniation, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Wang (+86 21-65161782-3136, wangke8430@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) total score (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.