Electroacupuncture Treatment for Discogenic Low Back Pain

February 2, 2026 updated by: Beijing Hospital

The Efficacy and Safety of Electroacupuncture Compared With Sham Acupuncture in Patients With Discogenic Low Back Pain: A Multicenter Randomized Controlled Trial

Low back pain (LBP) is a prevalent clinical condition characterized by pain localized between the lower edge of the 12th rib and the gluteal fold.The incidence of LBP has been escalating annually.An epidemiological survey encompassing 204 countries and territories globally projects a stark increase in the affected population, from an estimated 619 million in 2020 to a projected 843 million by 2050.LBP can affect individuals across all age groups, with a lifetime prevalence ranging from 60% to 80%, significantly impairing quality of life. Discogenic low back pain (DLBP), attributed to degenerative changes in the intervertebral discs, is the predominant subtype of LBP, comprising approximately 39% of all LBP cases. Disc degeneration typically initiates in early adulthood and progresses with age, potentially leading to DLBP.As the population ages, DLBP has emerged as a major contributor to disability worldwide, imposing a substantial burden on both individuals and society. Current international guidelines establish the foundation for surgical and pharmacological interventions for DLBP.However, considering the adverse effects and economic implications associated with surgical and medical treatments, there is a growing inclination towards recommending non-pharmacological therapies.These include physiotherapy, self-management, and psychotherapy, with a concurrent reduction in emphasis on pharmacological and surgical options.

Acupuncture and moxibustion are integral components of traditional Chinese medicine, garnering global recognition for their role in restoring the equilibrium of yin and yang within the human body . Electroacupuncture, a modern derivation of traditional acupuncture, has been extensively applied worldwide for the management of various painful conditions, including headache, myofibromyalgia, neck pain, and cancer-related pain. Despite its broad application, a limited number of clinical efficacy and safety studies have been conducted on electroacupuncture for the treatment of discogenic low back pain (DLBP), thereby necessitating a scientific foundation for its therapeutic use .

The present study aims to investigate the clinical efficacy and safety of electroacupuncture in the treatment of DLBP using an evidence-based medical approach. By employing a multicenter, randomized, and sham-controlled study design, this investigation seeks to provide a robust evidence-based medical foundation for the use of electroacupuncture in DLBP treatment.

Participants will be randomly assigned to either the acupuncture group (experimental group) or the sham acupuncture group (control group) in a 1:1 ratio, akin to a lottery drawing. Following enrollment, participants will undergo a 4-week, 12-session intervention, followed by three follow-up visits at 4, 12, and 24 weeks post-treatment. The investigators will assess participants' low back pain, lumbar spine function, and quality of life through telephone communication or on-site questioning at these designated follow-up intervals.

Needling may result in minor bleeding, pain, or hematoma at the needle site, and rare infections or allergic reactions may occur. Adverse reactions to needling, such as dizziness or nerve damage, are exceedingly rare.

Participants in this study may confer direct medical benefits, such as remission of symptoms, or may not, with outcomes ranging from no remission to potential exacerbation of the condition . However, the knowledge gained from this study is anticipated to benefit future people with similar conditions .

In addition to this study , participations may opt for treatment with modern rehabilitation medicine modalities or medications, including shortwave therapy, intermediate frequency therapy, or oral analgesics . This study would not impose any costs beyond the participants' regular medical treatment, and the investigators will cover all study-related medical expenses (including acupuncture treatment costs, needle costs, and scale evaluation costs) . The investigators are legally committed to maintaining the confidentiality of the participants' study records.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Wei Liu
          • Phone Number: 01085133411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. It meets the diagnostic criteria of discogenic low back pain
  2. Betweening 18 and 70 years of age (both 18 and 70) and of either sex
  3. Visual analog score (VAS) for low back pain ≥40 mm within the last 1 month

Exclusion Criteria:

  1. Patients with symptoms such as lower limb numbness, weakness and claudication as shown by lumbar disc herniation pressing the spinal nerve on imaging
  2. Lumbar tuberculosis, tumor, infection, spinal fracture, lumbar spondylolisthesis, severe osteoporosis
  3. Patients with a history of spinal and intervertebral disc surgery
  4. Patients with rheumatism, rheumatoid disease, systemic lupus erythematosus, hematopoietic system, endocrine system and psychiatric diseases
  5. Patients who have received radiofrequency, minimally invasive, ozone, small needle-knife, acupuncture, manipulation, traction, block therapy and other clinical trials within the last 1 month
  6. Patients with severe needle fainting intolerance
  7. Women who are pregnant, planning pregnancy or breastfeeding
  8. People with a history of opioid analgesics, sedatives and hypnotics and alcohol abuse
  9. Patients who plan to undergo acupuncture, massage, traction and other treatments related to this disease and other clinical research trials within 3 months of participating in the study
  10. Patients with skin damage or infection, concomitant bleeding tendency, tumor metastasis, serious heart disease, or embedded pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electroacupuncture group
In the electroacupuncture group, the acupuncture point prescription is based on the Evidence-based Practice Guidelines for Non-surgical Treatment of lumbar disc Herniation. The best clinical acupuncture treatment strategy was determined by the expert committee.Electroacupuncture was applied to the standard acupoints (BL-23,BL-25,EX-B2,BL-40,GB-34) for 30 min per treatment, and the treatment was performed 3 times per week (with an interval of 1-2 days between treatments), with a total of 12 treatments received over 4 weeks. Point selection and location refer to the current national standard "GB/T 12346-2021 Meridian point Name and Location".
Device: electroacupuncture group
According to the acupuncture prescription, the acupuncture doctor carried out acupuncture and lifting and twisting, and "qi" appeared under the needle. Select waist Jiaji point and Shenshu point on the same side to connect a set of electronic needle therapy instrument, the positive pole (red clip) connected to Shenshu point, the negative pole (white clip) connected to waist Jiaji point, after confirming that the electric current intensity of the electric needle instrument returns to zero, open the electronic needle therapy instrument, select continuous wave, 2Hz, current intensity 2mA. During the process of needle retention, the other points were injected every 15 minutes and retained for 30 minutes.The investigators have developed detailed acupoint positioning and operation rules.
Sham Comparator: sham-acupuncture group
In the sham-acupuncture group,the prescription of this sham acupuncture scheme was made with reference to SHARE: Report Guidelines and Clinical Trial List of sham acupuncture and Research on acupuncture point Localization in the treatment of chronic low back Pain.Sham-acupuncture treatments were performed on noacupoints (Sham-BL-23,Sham-BL-25,Sham-EX-B2,Sham-BL-40,Sham-GB-34) for a duration of 30 min for each treatment session, and 3 treatments were performed per week (with an interval of 1-2 days between each treatment session), for a total of 12 treatments over 4 weeks.
Device: sham-acupuncture group
The investigators fixed the foam pad with one hand and inserted a comfort needle with the other, making sure the needle only touched the surface of the skin and did not penetrate the point. After the completion of all acupoint operations, the operator selected the simulated needle insertion points of Jiaji point on the waist and Shenshu point on the same side. An electroacupuncture treatment device designed to connect a circuit interrupt treatment is operated with the electroacupuncture group, a process that ensures that the participant does not experience any perceptible stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
Visual Analogue Scale is one of the most commonly used single-dimension measurement and evaluation tools for pain intensity. The scale is mainly composed of a 100mm straight line, one end of which means "completely painless" and the other end means "the most severe pain imaginable" or "pain to the extreme." The patient will be asked to place a mark (with a dot) on the line to represent the intensity of the pain they are experiencing at the time.A higher score means a worse result.
Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
The Oswestry Disability Index is a scale commonly used to assess low back pain (LBP) dysfunction. It consists of 10 questions, including pain intensity, self-care, lifting, walking, sitting, standing, sleep disturbance, social life, travel, sex life and other 10 aspects, with 6 options for each question, the highest score of each question is 5 points, 0 points for choosing the first option, and 5 points for choosing the last option in turn. If 10 questions are answered, the scoring method is: actual score /50 (highest possible score) ×100%, if a question is not answered, the scoring method is: actual score /45 (highest possible score) ×100%, if the higher indicates the more serious dysfunction.
Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
Japanese Orthopaedic Association scores
Time Frame: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
The Japanese Orthopaedic Association score for low back pain includes four parts: subjective symptoms (low back pain, leg pain, gait), clinical signs (straight leg lifting, sensory impairment, motor impairment), limits of daily activities and bladder function, with a total score of 29. Improvement index = post-treatment score - pre-treatment score, post-treatment score improvement rate =[(post-treatment score - pre-treatment score)/pre-treatment score]×100%. The improvement index can reflect the improvement of lumbar function before and after treatment, and the clinical treatment effect can be understood by the improvement rate. The improvement rate can also correspond to the commonly used efficacy criteria: it is a cure when the improvement rate is 100%; it is significant when the improvement rate is greater than 60%; when the improvement rate is 25%-60%, it is effective; when it is less than 25%, it is ineffective.
Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
Hospital Anxiety and Depression Scale
Time Frame: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment

The Hospital anxiety and depression scale , which integrates the assessment of anxiety and depression, is mainly applied to the screening of anxiety and depression in patients in general hospitals, and is widely used in studies. Emotions play an important role in most illnesses, and if your doctor understands your mood changes, they can help you more. Please read the following items and put a "x" in brackets after the options that best match your mood over the past month. Don't think too much about the answers to these questions; immediate answers are often more realistic. Scoring criteria: This table includes 2 subscales of anxiety and depression, 7 questions each for anxiety [A] and depression [D].

The subscale of anxiety and depression was divided into the following scores: 0-7 were asymptomatic; 8-10 are suspicious; The genus 11-21 definitely exists; In the scoring, the starting point is 8, that is, both suspicious and symptomatic people are positive.
Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
the 12-items Short Form Health Survey
Time Frame: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
The 12-item Short From Health Survey contains 12 items and 8 dimensions, which are respectively physiological function, the impact of physiological function on role function, physical pain, general health, vitality, social function, physical function. Effects of emotions on role functions, mental health.The scale was scored on a percentage scale, and the higher the score, the higher the quality of life.
Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
Number of Participants Experiencing Adverse Reactions During Acupuncture
Time Frame: We will systematically monitor and document any adverse reactions (such as pain, bleeding, infection, etc.) following each session of acupuncture or sham acupuncture within a 4-week, 12-session intervention period. The observational period for this trial
We will record the total number of participants who experience any adverse reactions (such as pain, bleeding, infection, etc.) during the acupuncture treatment.
We will systematically monitor and document any adverse reactions (such as pain, bleeding, infection, etc.) following each session of acupuncture or sham acupuncture within a 4-week, 12-session intervention period. The observational period for this trial
Rate of Adverse Reactions During Acupuncture Treatment
Time Frame: Upon the conclusion of the trial, which is anticipated to span approximately 1.5 years, we will compute and report the incidence rate of adverse events based on the tally of occurrences.
Following the conclusion of the study, we will determine the incidence rate of adverse reactions experienced during the course of acupuncture or sham acupuncture treatment.
Upon the conclusion of the trial, which is anticipated to span approximately 1.5 years, we will compute and report the incidence rate of adverse events based on the tally of occurrences.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acupuncture Treatment Expectation for Treatment Scale
Time Frame: Measured before the first pinprick and within 10 minutes after the last pinprick
There are several options in the table that indicate participants' expectations for acupuncture treatment. There is no right or wrong answer. A higher score indicates a higher expectation for treatment, and a lower score indicates a lower expectation for treatment.
Measured before the first pinprick and within 10 minutes after the last pinprick
Acupuncture blind method implementation evaluation scale
Time Frame: Measured before the first pinprick and within 10 minutes after the last pinprick
Participants in both groups were evaluated for blinding while receiving electroacupuncture or a dummy needle. Participants' feelings about the intervention were recorded with "yes," "no," or "unclear."
Measured before the first pinprick and within 10 minutes after the last pinprick

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Collaborators

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Dongzhimen Hospital, Beijing
Dongfang Hospital Beijing University of Chinese Medicine
Changshu Hospital of Traditional Chinese Medicine
Shenzhen Hospital of Traditional Chinese Medicine
Beijing University of Chinese Medicine, Shenzhen Hospital
Beijing Massage Hospital

Investigators

  • Study Chair: Guodong Ni, MMed, Department of Acupuncture and Massage, Beijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024BJYYEC-KY198-04
  • BJ-2024-205 (Other Grant/Funding Number: National High Level Hospital Clinical ResearcrFunding)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share de-identified individual participant data with others for six months after publication.

IPD Sharing Time Frame

The IPD analysis will be shared by June 1, 2026.

IPD Sharing Access Criteria

The data shared will include participant characteristics, clinical measurements, adverse events, and clinical outcomes. This data will be provided through a secure online platform or database, ensuring data security and privacy protection. The data will be shared with researchers who make legitimate requests for data, including research hypotheses, research justifications, analysis plans, publication plans, and the credentials of the research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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