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Not yet recruiting NCT06611332

Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

No phase Interventional Lumbar Disc Herniation Radiculopathy Lumbar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroacupuncture, Sham electroacupuncture.
Who it may be relevant to
Registry conditions: Lumbar Disc Herniation, Radiculopathy Lumbar. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial

Overview

Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.

Interventions

  • Other Electroacupuncture
    The main acupoints selected for the electroacupuncture group are bilateral BL23, bilateral BL25, bilateral GB30, bilateral LR11, bilateral LR8, GV4, GV3, and the affected BL40, and the secondary acupoints selected are bilateral BL54, the affected side BL57 and the affected side BL60.The treatment will be administered once every other day for 30 minutes each time, lasting for 8 consecutive weeks, totaling 24 sessions.
  • Other Sham electroacupuncture
    In the sham electroacupuncture group, the acupoints will be at a position 2 cm lateral to the correct acupoints horizontally. The dosage and treatment course are the same as those in the electroacupuncture group.

Primary outcome measures

  • Proportion of responders [Time frame: Weeks 8 and 24]
Secondary outcome measures (12)
  • Intensity of low back pain [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Intensity of leg pain [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Level of disability [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Performance status [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Severity of depression [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Severity of anxiety [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Sleep quality [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Pain self-efficacy [Time frame: Weeks 2, 4, 8, 16, and 24]
  • Use of analgesics [Time frame: Weeks 8 and 24]
  • Incidence of lumbar spine surgery [Time frame: Weeks 8 and 24]
  • Incidence of any adverse events [Time frame: Weeks 8 and 24]
  • Incidence of treatment-related adverse events [Time frame: Weeks 8 and 24]

Eligibility criteria

Inclusion criteria

  • Aged from 18 to 70 years old.
  • With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
  • With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
  • Voluntarily participating the trial and signing the informed consent form.

Exclusion criteria

  • Previous surgical treatment of the spine.
  • Received any physical therapy for lumbar disc herniation within the recent 3 months.
  • Complicated with diseases that can cause low back and leg pain.
  • Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
  • Previous severe mental illness, organ failure, or malignant tumor.
  • Planned spinal surgery or other major surgeries within the next 3 months.
  • Pregnancy or lactation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

China · 1 center
  • The Affiliated Hospital of Jiangxi University of Chinese Medicine — Jiangxi

Publications

  • Yang Y, Liu L, Yuan L, Liu X, Ding H, Zhou X, Cao Q. A Randomized, Sham-Controlled Trial on the Efficacy and Safety of Electroacupuncture for Lumbar Disc Herniation with Radiculopathy: Rationale and Study Protocol. J Pain Res. 2025 May 5;18:2307-2319. doi: 10.2147/JPR.S512711. eCollection 2025. PMID 40352817

Identifiers

NCT: NCT06611332 · JXUCM-ACU-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗