Electroacupuncture Treatment for Discogenic Low Back Pain
NCT ID: NCT06703671
Last Updated: 2025-04-10
Study Results
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Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-03-08
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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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".
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-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.
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
Interventions
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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-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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Dongzhimen Hospital, Beijing
OTHER
Changshu City Hospital of Traditional Chinese Medicine
UNKNOWN
Shenzhen Hospital of Traditional Chinese Medicine
UNKNOWN
Beijing Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Guodong Ni, MMed
Role: STUDY_CHAIR
Department of Acupuncture and Massage, Beijing Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Liu
Role: primary
References
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Other Identifiers
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BJ-2024-205
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024BJYYEC-KY198-02
Identifier Type: -
Identifier Source: org_study_id
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