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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
170
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.
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.
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Jiangxi, Nanchang, China
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.
Time frame: Weeks 8 and 24
Intensity of low back pain
Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale
Time frame: 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
Time frame: 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
Time frame: Weeks 2, 4, 8, 16, and 24
Performance status
Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score
Time frame: 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
Time frame: 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
Time frame: Weeks 2, 4, 8, 16, and 24
Sleep quality
Changes from baseline in sleep quality assessed by the Insomnia Severity Index
Time frame: Weeks 2, 4, 8, 16, and 24
Pain self-efficacy
Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire
Time frame: Weeks 2, 4, 8, 16, and 24
Use of analgesics
The proportion of patients who used analgesics for emergency.
Time frame: Weeks 8 and 24
Incidence of lumbar spine surgery
The incidence of lumbar spine surgery during the follow-up
Time frame: Weeks 8 and 24
Incidence of any adverse events
Adverse events be reported by patients and determined by clinicians.
Time frame: Weeks 8 and 24
Incidence of treatment-related adverse events
Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.
Time frame: 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.
Time frame: Weeks 8 and 24
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