Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangxi University of Traditional Chinese Medicine

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electroacupuncture

    Other intervention

    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 electroacupuncture

    Other intervention

    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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: ElectroacupunctureExperimental treatment 1 intervention
Group B: Sham electroacupunctureSham comparator 1 intervention

Trial outcomes

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.

Time frame
Weeks 8 and 24

Secondary outcomes

1

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
2

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
3

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
4

Performance status

Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score

Time frame
Weeks 2, 4, 8, 16, and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: