Discogenic Low Back PainNCT06703671
Electroacupuncture Treatment for Discogenic Low Back Pain
A study testing electroacupuncture group in people with Discogenic Low Back Pain, run by Beijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Discogenic Low Back Pain
- What is being tested?
- electroacupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Wei Liu, 01085133411
About this study
Official title: 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 .
Read more
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
- Being tested
- electroacupuncture group, sham-acupuncture group
- Keywords
- Discogenic low back pain, electroacupuncture, Sham Acupuncture, A Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture groupDevice
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 groupDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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. Receives: Device: sham-acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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
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: 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
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: 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
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: 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 record the total number of participants who experience any adverse reactions (such as pain, bleeding, infection, etc.) during the acupuncture treatment.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start8 Mar 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Discogenic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Dongzhimen Hospital, Beijing, Changshu Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Beijing Massage Hospital, Beijing University of Chinese Medicine, Shenzhen Hospital, Dongfang Hospital Beijing University of Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Guodong Ni, MMed, Study chair, Department of Acupuncture and Massage, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703671
- Sponsor's protocol ID
- 2024BJYYEC-KY198-04
- Other IDs
- BJ-2024-205
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data with others for six months after publication.
Publications
Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. 2023 Sep 5;6(9):e2332452. doi: 10.1001/jamanetworkopen.2023.32452.
PubMed 37672270Ma P, Liu X, Liu Z, Guo Y, Zhou K, Bian Z, Sun C, Liu T, Xiong Z, Xie Y, Lu Y, Lao L, He L, Liu B, Liu C, Yan S; SHARE Workgroup. The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials. J Evid Based Med. 2023 Dec;16(4):428-431. doi: 10.1111/jebm.12560. Epub 2023 Oct 31. No abstract available.
PubMed 37906211Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266Tu JF, Shi GX, Yan SY, Ni GX, Yu FT, Cai GW, Liu ZS, Ma CY, Wang LQ, Yang JW, Zhou XQ, Meng XL, Fu HY, Li J, Wan WJ, Sun TH, Wang XZ, Liu CZ. Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1417-1424. doi: 10.1001/jamainternmed.2024.5463.
PubMed 39401008Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22.
PubMed 32333996Kim G, Kim D, Moon H, Yoon DE, Lee S, Ko SJ, Kim B, Chae Y, Lee IS. Acupuncture and Acupoints for Low Back Pain: Systematic Review and Meta-Analysis. Am J Chin Med. 2023;51(2):223-247. doi: 10.1142/S0192415X23500131. Epub 2022 Dec 31.
PubMed 36585839He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.
PubMed 31855257Castellini G, Pillastrini P, Vanti C, Bargeri S, Giagio S, Bordignon E, Fasciani F, Marzioni F, Innocenti T, Chiarotto A, Gianola S, Bertozzi L. Some conservative interventions are more effective than others for people with chronic non-specific neck pain: a systematic review and network meta-analysis. J Physiother. 2022 Oct;68(4):244-254. doi: 10.1016/j.jphys.2022.09.007. Epub 2022 Oct 17.
PubMed 36266185Deare JC, Zheng Z, Xue CC, Liu JP, Shang J, Scott SW, Littlejohn G. Acupuncture for treating fibromyalgia. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007070. doi: 10.1002/14651858.CD007070.pub2.
PubMed 23728665Coeytaux RR, Befus D. Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders. Headache. 2016 Jul;56(7):1238-40. doi: 10.1111/head.12857. Epub 2016 Jul 13.
PubMed 27411557Chen HY, Yeung WF, Yang MX, Mu JL, Ziea TC, Ng Bacon FL, Lao LX. Guideline Acupuncture for low back pain: a clinical practice guideline from the Hong Kong taskforce of standardized acupuncture practice. J Tradit Chin Med. 2022 Feb;42(1):140-147. doi: 10.19852/j.cnki.jtcm.2022.01.009.
PubMed 35294134Tang X, Shi X, Zhao H, Lu L, Chen Z, Feng Y, Liu L, Duan R, Zhang P, Xu Y, Cui S, Gong F, Fei J, Xu NG, Jing X, Guyatt G, Zhang YQ. Characteristics and quality of clinical practice guidelines addressing acupuncture interventions: a systematic survey of 133 guidelines and 433 acupuncture recommendations. BMJ Open. 2022 Feb 24;12(2):e058834. doi: 10.1136/bmjopen-2021-058834.
PubMed 35210347Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
PubMed 29573872Nicol V, Verdaguer C, Daste C, Bisseriex H, Lapeyre E, Lefevre-Colau MM, Rannou F, Roren A, Facione J, Nguyen C. Chronic Low Back Pain: A Narrative Review of Recent International Guidelines for Diagnosis and Conservative Treatment. J Clin Med. 2023 Feb 20;12(4):1685. doi: 10.3390/jcm12041685.
PubMed 36836220Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Electroacupuncture Compared With Sham Acupuncture in Patients With Discogenic Low Back Pain: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06703671
- Acronym / sponsor ID
- 2024BJYYEC-KY198-04
- Conditions
- Discogenic Low Back Pain
- Keywords
- Discogenic low back pain, electroacupuncture, Sham Acupuncture, A Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Dongzhimen Hospital, Beijing, Changshu Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Beijing Massage Hospital, Beijing University of Chinese Medicine, Shenzhen Hospital, Dongfang Hospital Beijing University of Chinese Medicine
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Device: electroacupuncture groupIn 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". |
| sham-acupuncture group | Sham comparator | Device: sham-acupuncture groupIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncture groupAccording 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. | Device | electroacupuncture group |
| sham-acupuncture groupThe 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 | Device | sham-acupuncture group |
Primary outcome
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.
6 secondary outcomes
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
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
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 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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Results publication: PubMed 37672270Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. 2023 Sep 5;6(9):e2332452. doi: 10.1001/jamanetworkopen.2023.32452.
- Results publication: PubMed 37906211Ma P, Liu X, Liu Z, Guo Y, Zhou K, Bian Z, Sun C, Liu T, Xiong Z, Xie Y, Lu Y, Lao L, He L, Liu B, Liu C, Yan S; SHARE Workgroup. The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials. J Evid Based Med. 2023 Dec;16(4):428-431. doi: 10.1111/jebm.12560. Epub 2023 Oct 31. No abstract available.
- Results publication: PubMed 18055266Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Results publication: PubMed 39401008Tu JF, Shi GX, Yan SY, Ni GX, Yu FT, Cai GW, Liu ZS, Ma CY, Wang LQ, Yang JW, Zhou XQ, Meng XL, Fu HY, Li J, Wan WJ, Sun TH, Wang XZ, Liu CZ. Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1417-1424. doi: 10.1001/jamainternmed.2024.5463.
- Results publication: PubMed 32333996Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22.
- Results publication: PubMed 36585839Kim G, Kim D, Moon H, Yoon DE, Lee S, Ko SJ, Kim B, Chae Y, Lee IS. Acupuncture and Acupoints for Low Back Pain: Systematic Review and Meta-Analysis. Am J Chin Med. 2023;51(2):223-247. doi: 10.1142/S0192415X23500131. Epub 2022 Dec 31.
- Results publication: PubMed 31855257He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.
- Results publication: PubMed 36266185Castellini G, Pillastrini P, Vanti C, Bargeri S, Giagio S, Bordignon E, Fasciani F, Marzioni F, Innocenti T, Chiarotto A, Gianola S, Bertozzi L. Some conservative interventions are more effective than others for people with chronic non-specific neck pain: a systematic review and network meta-analysis. J Physiother. 2022 Oct;68(4):244-254. doi: 10.1016/j.jphys.2022.09.007. Epub 2022 Oct 17.
- Results publication: PubMed 23728665Deare JC, Zheng Z, Xue CC, Liu JP, Shang J, Scott SW, Littlejohn G. Acupuncture for treating fibromyalgia. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007070. doi: 10.1002/14651858.CD007070.pub2.
- Results publication: PubMed 27411557Coeytaux RR, Befus D. Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders. Headache. 2016 Jul;56(7):1238-40. doi: 10.1111/head.12857. Epub 2016 Jul 13.
- Results publication: PubMed 35294134Chen HY, Yeung WF, Yang MX, Mu JL, Ziea TC, Ng Bacon FL, Lao LX. Guideline Acupuncture for low back pain: a clinical practice guideline from the Hong Kong taskforce of standardized acupuncture practice. J Tradit Chin Med. 2022 Feb;42(1):140-147. doi: 10.19852/j.cnki.jtcm.2022.01.009.
- Results publication: PubMed 35210347Tang X, Shi X, Zhao H, Lu L, Chen Z, Feng Y, Liu L, Duan R, Zhang P, Xu Y, Cui S, Gong F, Fei J, Xu NG, Jing X, Guyatt G, Zhang YQ. Characteristics and quality of clinical practice guidelines addressing acupuncture interventions: a systematic survey of 133 guidelines and 433 acupuncture recommendations. BMJ Open. 2022 Feb 24;12(2):e058834. doi: 10.1136/bmjopen-2021-058834.
- Individual participant dataSharing planned: Yes. We will share de-identified individual participant data with others for six months after publication.
Related trials for Discogenic Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Recruiting
Discogen for Low Back Pain
Disc Herniation
RecruitingObservational study
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
Low Back Pain
Not yet recruitingPhase 1
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease
Active, not recruitingObservational study
VIA Disc NP Registry 3.0
Discogenic Pain, Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guodong Ni, MMed study chair
Department of Acupuncture and Massage, Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture group in people with Discogenic Low Back Pain, run by Beijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guodong Ni, MMed (+8618601349676, nigd4785@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703671, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.