Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- Lower limb nerve conduction velocity
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Electroacupuncture (EA) may provide a safe, non-pharmacological treatment option, but further clinical evidence is needed.
The purpose of this study is to evaluate the efficacy and potential mechanisms of low-frequency (2 Hz) electroacupuncture in patients with DPN. In this prospective, randomized, sham-controlled trial, participants will be assigned to either a verum 2 Hz EA group or a sham EA group. The study will assess nerve conduction velocity, pain intensity, serum neurotrophic factors and inflammatory cytokines, and quality of life.
This study is intended to provide clinical evidence on the use of low-frequency EA for DPN and to examine whether its effects are related to neurotrophic and inflammatory pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 1.Aged 18-70 years, with no restriction on disease duration or sex. 2.Met the diagnostic criteria for DPN, evidenced by: decreased NCV on lower-limb electroneurography, and/or persistent pain and/or sensory abnormalities in the limbs (at least in both lower limbs), with diminished ankle reflex (unilateral or bilateral) and reduced vibration sense, and a Toronto Clinical Scoring System (TCSS) score ≥
- •3.Able to communicate effectively. 4.No severe systemic medical conditions (e.g., cardiac, cerebral, hepatic, or renal disorders), severe psychiatric illnesses, or cognitive impairment.
- •5.Mentally competent, voluntarily agree to participate in the study, and provide written informed consent.
排除标准
- •1.Peripheral neuropathy due to other etiologies (e.g., hypothyroidism, alcohol, medications, hereditary causes), presence of limb ulcers or gangrene, or a history of skin ulceration or poorly healing lesions.
- •2.Severe comorbid conditions, including renal, cardiovascular, cerebrovascular, pulmonary, or hepatic diseases, infectious diseases, malignancies, or severe psychiatric disorders.
- •3.History of knee/hip replacement surgery or lower limb fracture within the past 3 months, or any other condition that could interfere with the assessment of neuropathy.
- •4.Received acupuncture or moxibustion treatment specifically for DPN within the past 3 months.
- •5.Concurrent participation in another interventional clinical trial. 6.Women who are planning pregnancy, are pregnant, or are lactating. 7.Unwillingness to be randomized to either the waitlist (WL) or EA group. 8.Chronic abuse of opioids, analgesics, illicit drugs, or alcohol.
研究组 & 干预措施
EA
The primary acupoints, included GB34, ST36, ST39 GB39, SP9, SP6,ST41, LR3, and GB41. Supplementary acupoints were added based on clinical presentation: BL60, ST44, and EX-LE10 for significant lower limb pain; and LI11，LI10) SJ5,LI4, and EX-UE9 for concomitant upper limb pain. Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant.
干预措施: EA (Other)
Sham EA
In the sham EA group, two non-acupoint locations on each lower limb were selected. Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session.
干预措施: Sham EA (Other)
结局指标
主要结局
Lower limb nerve conduction velocity
时间窗: Baseline (week 0) and week 6 (±3 days)
Lower limb nerve conduction velocity (NCV) will be measured at baseline and at the end of the 6-week intervention. Assessments will include motor NCV and sensory NCV of the bilateral common peroneal nerves and tibial nerves.
Overall clinical response rate
时间窗: At the end of week 6 (±3 days).
Overall clinical response rate will be assessed at the end of the 6-week treatment period. Treatment efficacy will be categorized into three levels: marked effective, effective, and ineffective. Marked effective will be defined as significant subjective symptom relief accompanied by an increase in nerve conduction velocity (NCV) of ≥5 m/s on electromyography, or recovery to near-normal levels. Effective will be defined as subjective clinical improvement with an NCV increase of \<5 m/s. Ineffective will be defined as no significant improvement in clinical symptoms, tendon reflexes, sensory perception, or NCV. The overall clinical response rate will be calculated as (number of marked effective cases + number of effective cases) / total number of participants × 100%.
次要结局
- Visual Analog Scale score(At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days))
- Toronto Clinical Scoring System score(At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days))
- Diabetes Quality of Life scale score(At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days))
- Serum nerve growth factor concentration(At baseline (week 0), week 3 (±3 days), week 6 (±3 days))
- Serum brain-derived neurotrophic factor concentration(At baseline (week 0), week 3 (±3 days), week 6 (±3 days))
- Serum tumor necrosis factor-alpha concentration(At baseline (week 0), week 3 (±3 days), week 6 (±3 days))
- Serum interleukin-6 concentration(At baseline (week 0), week 3 (±3 days), week 6 (±3 days))
- Hemoglobin A1c(At baseline (week 0), week 6 (±3 days),)
- Fasting plasma glucose(At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days))
- 2-hour postprandial glucose(At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days))