Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy

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

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

• 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.