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Electroacupuncture for Diabetic Peripheral Neuropathy: Study Protocol for a Three-Armed Randomized Controlled Trial

Electroacupuncture for Diabetic Peripheral Neuropathy: Study Protocol for a Three-Armed Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061408
Enrollment
Unknown
Registered
2022-06-23
Start date
2022-10-20
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Interventions

Electroacupuncture group:Electroacupuncture
Sham electroacupuncture group:Sham acupuncture

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with diabetes mellitus; 2. The patient was diagnosed with distal symmetrical polyneuropathy of diabetes mellitus, and related symptoms had been present for more than 6 months; 3. Aged 18-75 years; 4. Total Symptom Score (TSS) of diabetic distal symmetric multiple neuropathy >= 5 points; 5. Have not received drug treatment for diabetic distal symmetrical polyneuropathy in the past 1 month, have not received acupuncture treatment in the past 3 months, and have not participated in other ongoing clinical studies; 6. Sign informed consent to participate in the study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Glycosylated hemoglobin > 10%; 2. Implantation of a pacemaker; 3. Pregnancy, lactation or planned pregnancy; 4. Patients with malignant tumors or chemotherapy, severe cardiovascular and cerebrovascular diseases, infectious diseases, vitamin B12 deficiency, cervical and lumbar spine diseases, hereditary neuropathy, liver and kidney insufficiency; Alcoholism; 5. Have a history of cerebral hemorrhage, inherited hemorrhagic disease (such as hemophilia), or are using anticoagulant drugs such as warfarin; 6. Foot ulcer or gangrene; 7. Patients with cognitive dysfunction, aphasia, or mental disorders cannot cooperate with this study.

Design outcomes

Primary

MeasureTime frame
Total symptom score;

Secondary

MeasureTime frame
Numeric rating scale for pain intensity;12-item short-form health survey;Treatment expectancy;Adverse events;Nerve conduction velocity;Response rate for Total Symptom Score;Total symptom score;

Countries

China

Contacts

Public ContactYan Shiyan

Beijing University of Chinese Medicine

yanshiyan@bucm.edu.cn+86 10 6428 7525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026