Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

Jiangxi University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Radiculopathy Lumbar; Lumbar Disc Herniation

Treatments: Other: Electroacupuncture; Other: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06611332

JXUCM-ACU-01

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups

Electroacupuncture

Experimental group

Treatment:

Other: Electroacupuncture

Sham electroacupuncture

Sham Comparator group

Treatment:

Other: Sham electroacupuncture