Electroacupuncture Treatment for Discogenic Low Back Pain

NCT06703671 | Recruiting DMC

• 2 other identifiers: 2024BJYYEC-KY198-04BJ-2024-205
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Discogenic Low Back Pain

Keywords

Discogenic low back pain; electroacupuncture; Sham Acupuncture; A Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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 Outcomes (6)

• Oswestry disability index

  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

  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

  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

  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

  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

Other Outcomes (2)

• Acupuncture Treatment Expectation for Treatment Scale

  Measured before the first pinprick and within 10 minutes after the last pinprick

• Acupuncture blind method implementation evaluation scale

  Measured before the first pinprick and within 10 minutes after the last pinprick

Study Arms (2)

electroacupuncture group

EXPERIMENTAL

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

sham-acupuncture group

SHAM COMPARATOR

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

Interventions

electroacupuncture group DEVICE

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.

electroacupuncture group

sham-acupuncture group DEVICE

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

sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with symptoms such as lower limb numbness, weakness and claudication as shown by lumbar disc herniation pressing the spinal nerve on imaging
• Lumbar tuberculosis, tumor, infection, spinal fracture, lumbar spondylolisthesis, severe osteoporosis
• Patients with a history of spinal and intervertebral disc surgery
• Patients with rheumatism, rheumatoid disease, systemic lupus erythematosus, hematopoietic system, endocrine system and psychiatric diseases
• 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
• Patients with severe needle fainting intolerance
• Women who are pregnant, planning pregnancy or breastfeeding
• People with a history of opioid analgesics, sedatives and hypnotics and alcohol abuse
• 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
• Patients with skin damage or infection, concomitant bleeding tendency, tumor metastasis, serious heart disease, or embedded pacemaker

Sponsors & Collaborators

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

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (21)

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Study Officials

• Guodong Ni, MMed

  Department of Acupuncture and Massage, Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Guodong Ni, MMed

CONTACT

+8618601349676; nigd4785@126.com

zengbing Ma, PD

CONTACT

+8613811554913; mazb2002@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcome assessors, and statisticians were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: In the electroacupuncture group, electroacupuncture was applied to selected acupoints for 30 min per treatment, and the treatment was performed 3 times per week (1-2 days between each treatment), receiving a total of 12 treatments in 4 weeks. Considering the possibility of uncontrollable factors such as temporary outings and overtime work during the treatment period, we will allow subjects to miss a maximum of 3 treatments, including 2 consecutive treatments. In the sham acupuncture group, placebo-needle treatment was performed on nonacupoints 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 in 4 weeks. Considering the possibility of uncontrollable factors such as temporary outings, overtime work, etc. during the treatment period, we will allow subjects to miss a maximum of 3 treatments, including 2 consecutive treatments.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 25, 2024
• Study Start: March 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD analysis will be shared by June 1, 2026.
• 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.

Locations

CN (1)