Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

NCT ID: NCT06611332

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-10-25

Brief Summary

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.

Conditions

Lumbar Disc Herniation; Radiculopathy Lumbar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Electroacupuncture

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: OTHER

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.

Sham electroacupuncture

Group Type: SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xu Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Hospital of Jiangxi University of Chinese Medicine

Jiangxi, Nanchang, China

Countries

China

Facility Contacts

Xu Zhou Professor, M.D.

Role: primary

88299077@qq.com

+86-0791-86363831

References

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.

Reference Type: DERIVED

PMID: 40352817 (View on PubMed)

Other Identifiers

JXUCM-ACU-01

Identifier Type: -

Identifier Source: org_study_id