An interventional study of Electroacupuncture and Sham electroacupuncture in Sciatica, Lumbar Disc Herniation and Insomnia, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Not applicable, Interventional, and Treatment
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 114 is above the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will be eligible if they meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if any of the following criteria are met:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Electroacupuncture
Procedure: Sham electroacupuncture
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 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).
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.
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Resting-state electroencephalography-derived microstate parameters
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.
Time frame: Baseline, Week 4
Untargeted plasma metabolomic features
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.
Time frame: Baseline, Week 4
Credibility/Expectancy Questionnaire scores
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.
Time frame: Baseline
Bang blinding index
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.
Time frame: Week 4
No study locations are listed for this record.
Start is estimated for May 2026; primary completion for Feb 2027, 9 months later.
Of 44 non-industry interventional studies with no phase under Sciatica, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 9 months is below that.
Counting every sponsor, half of 44 studies reached it within 11 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Yueyang Integrated Medicine Hospital