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NOT YET RECRUITING
NCT07551726
NA

Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy

Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2026-04-26

Completion Date

2027-12-31

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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 screen remained active, no actual electrical current was delivered to the needles throughout the session.