Electroacupuncture Treatment for Discogenic Low Back Pain

Not Applicable

Recruiting

• Conditions: Discogenic Low Back Pain

• Registration Number: NCT06703671
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-10
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Status Verified: 2025-01
• Study Start: 2025-03-08
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue 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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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 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.
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	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.
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	We will record the total number of participants who experience any adverse reactions (such as pain, bleeding, infection, etc.) during the acupuncture treatment.
Rate of Adverse Reactions During 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.	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.

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China