Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy

Официальное название

Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое EA
  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.
• Другое Sham EA
  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

Первичные конечные точки

• Lower limb nerve conduction velocity [Срок оценки: Baseline (week 0) and week 6 (±3 days)]
• Overall clinical response rate [Срок оценки: At the end of week 6 (±3 days).]

Вторичные конечные точки (10)

• Visual Analog Scale score [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)]
• Toronto Clinical Scoring System score [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)]
• Diabetes Quality of Life scale score [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)]
• Serum nerve growth factor concentration [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)]
• Serum brain-derived neurotrophic factor concentration [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)]
• Serum tumor necrosis factor-alpha concentration [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)]
• Serum interleukin-6 concentration [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)]
• Hemoglobin A1c [Срок оценки: At baseline (week 0), week 6 (±3 days),]
• Fasting plasma glucose [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)]
• 2-hour postprandial glucose [Срок оценки: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)]

Критерии участия

Критерии включения

\- 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 ≥ 6.

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07551726 · 2026-KL-189-01-DPN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗