Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

NCT06611332 | Not Yet Recruiting DMC

• 1 other identifier: JXUCM-ACU-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

electroacupuncture; radiculopathy; sham control; randomized controlled trial; lumbar disc herniation

Outcome Measures

Primary Outcomes (1)

• Proportion of responders

  Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain.

  Weeks 8 and 24

Secondary Outcomes (13)

• Intensity of low back pain

  Weeks 2, 4, 8, 16, and 24

• Intensity of leg pain

  Weeks 2, 4, 8, 16, and 24

• Level of disability

  Weeks 2, 4, 8, 16, and 24

• Performance status

  Weeks 2, 4, 8, 16, and 24

• Severity of depression

  Weeks 2, 4, 8, 16, and 24

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

Other: Electroacupuncture

Sham electroacupuncture

SHAM COMPARATOR

Other: Sham electroacupuncture

Interventions

Electroacupuncture 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.

Electroacupuncture

Sham electroacupuncture 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.

Sham electroacupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead

Study Sites (1)

The Affiliated Hospital of Jiangxi University of Chinese Medicine

Jiangxi, Nanchang, 330006, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: October 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 25, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)