Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Disc Herniation; Radiculopathy Lumbar
• Intervention / Treatment: Other: Electroacupuncture; Other: Sham electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanchang
    • Jiangxi, Nanchang, China, 330006
      • The Affiliated Hospital of Jiangxi University of Chinese Medicine
      • Contact: Xu Zhou Professor, M.D.; Phone Number: +86-0791-86363831; Email: 88299077@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture	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.
Sham Comparator: Sham electroacupuncture	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of low back pain	Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale	Weeks 2, 4, 8, 16, and 24
Intensity of leg pain	Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale	Weeks 2, 4, 8, 16, and 24
Level of disability	Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire	Weeks 2, 4, 8, 16, and 24
Performance status	Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score	Weeks 2, 4, 8, 16, and 24
Severity of depression	Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale	Weeks 2, 4, 8, 16, and 24
Severity of anxiety	Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale	Weeks 2, 4, 8, 16, and 24
Sleep quality	Changes from baseline in sleep quality assessed by the Insomnia Severity Index	Weeks 2, 4, 8, 16, and 24
Pain self-efficacy	Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire	Weeks 2, 4, 8, 16, and 24
Use of analgesics	The proportion of patients who used analgesics for emergency.	Weeks 8 and 24
Incidence of lumbar spine surgery	The incidence of lumbar spine surgery during the follow-up	Weeks 8 and 24
Incidence of any adverse events	Adverse events be reported by patients and determined by clinicians.	Weeks 8 and 24
Incidence of treatment-related adverse events	Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.	Weeks 8 and 24
Incidence of serious adverse event	Serious adverse events refer to adverse events that require hospitalization or an extended hospital stay, result in disability, pose a threat to life, or cause death.	Weeks 8 and 24

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): October 25, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; lumbar disc herniation; electroacupuncture; radiculopathy; sham control
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: JXUCM-ACU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No