Clinical trial NCT06611332: Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy
Official title: Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Radiculopathy Lumbar
Keywords: electroacupuncture
radiculopathy
sham control
randomized controlled trial
lumbar disc herniation
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Proportion of responders
timeFrame: Weeks 8 and 24
Secondary outcomes:
measure: Intensity of low back pain
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Intensity of leg pain
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Level of disability
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Performance status
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Severity of depression
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Severity of anxiety
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Sleep quality
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Pain self-efficacy
timeFrame: Weeks 2, 4, 8, 16, and 24
measure: Use of analgesics
timeFrame: Weeks 8 and 24
measure: Incidence of lumbar spine surgery
timeFrame: Weeks 8 and 24
measure: Incidence of any adverse events
timeFrame: Weeks 8 and 24
measure: Incidence of treatment-related adverse events
timeFrame: Weeks 8 and 24
measure: Incidence of serious adverse event
timeFrame: Weeks 8 and 24
Other outcomes:
Locations:
city: Jiangxi
country: China
facility: The Affiliated Hospital of Jiangxi University of Chinese Medicine
state: Nanchang
Study officials:
References: