Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

Not Applicable

Not yet recruiting

• Conditions: Lumbar Disc Herniation; Radiculopathy Lumbar
• Interventions: Other: Electroacupuncture; Other: Sham electroacupuncture

• Registration Number: NCT06611332
• Lead Sponsor: Jiangxi University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-10-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	-
Sham electroacupuncture	Sham electroacupuncture	-

Primary Outcome Measures

Name	Time	Method
Proportion of responders	Weeks 8 and 24	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Jiangxi University of Chinese Medicine; 🇨🇳 Jiangxi, Nanchang, China