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NCT Number: NCT06611332

Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Radiculopathy Lumbar Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Jiangxi University of Chinese Medicine

Jiangxi, Nanchang, 330006, China

Location contact

Xu Zhou Professor, M.D.

CONTACT

[email protected]

+86-0791-86363831

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Previous severe mental illness, organ failure, or malignant tumor.
  • Planned spinal surgery or other major surgeries within the next 3 months.
  • Pregnancy or lactation.

Treatment and study plan

electroacupuncture

Other

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

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.

Primary outcomes

  1. Proportion of responders

    Time frame: 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 outcomes

  1. Intensity of low back pain

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

    Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale

  2. Intensity of leg pain

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

    Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale

  3. Level of disability

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

    Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire

  4. Performance status

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

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

  5. Severity of depression

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

    Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale

  6. Severity of anxiety

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

    Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale

  7. Sleep quality

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

    Changes from baseline in sleep quality assessed by the Insomnia Severity Index

  8. Pain self-efficacy

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

    Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire

  9. Use of analgesics

    Time frame: Weeks 8 and 24

    The proportion of patients who used analgesics for emergency.

  10. Incidence of lumbar spine surgery

    Time frame: Weeks 8 and 24

    The incidence of lumbar spine surgery during the follow-up

  11. Incidence of any adverse events

    Time frame: Weeks 8 and 24

    Adverse events be reported by patients and determined by clinicians.

  12. Incidence of treatment-related adverse events

    Time frame: Weeks 8 and 24

    Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.

  13. Incidence of serious adverse event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiangxi University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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