Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy

NCT07551726 | Not Yet Recruiting DMC

• 1 other identifier: 2026-KL-189-01-DPN
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Peripheral Neuropathy (DPN); Electroacupuncture

Outcome Measures

Primary Outcomes (2)

• Lower limb nerve conduction velocity

  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.

  Baseline (week 0) and week 6 (±3 days)

• Overall clinical response rate

  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%.

  At the end of week 6 (±3 days).

Secondary Outcomes (10)

• 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)

Study Arms (2)

EA

EXPERIMENTAL

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.

Other: EA

Sham EA

SHAM COMPARATOR

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.

Other: Sham EA

Interventions

EA OTHER

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.

EA

Sham EA OTHER

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.

Sham EA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• Able to communicate effectively. 4.No severe systemic medical conditions (e.g., cardiac, cerebral, hepatic, or renal disorders), severe psychiatric illnesses, or cognitive impairment.
• Mentally competent, voluntarily agree to participate in the study, and provide written informed consent.

You may not qualify if:

• 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.
• Severe comorbid conditions, including renal, cardiovascular, cerebrovascular, pulmonary, or hepatic diseases, infectious diseases, malignancies, or severe psychiatric disorders.
• 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.
• Received acupuncture or moxibustion treatment specifically for DPN within the past 3 months.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator

Central Study Contacts

Ning Luo

CONTACT

+8615083521014; 921941696@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04