Shortwave Intervention for Diabetic Peripheral Neuropathy.

Официальное название

Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)

Обзор

This study is a single-center, randomized, single-blind, sham-controlled clinical trial aimed at evaluating the efficacy and safety of shortwave therapy administered for five consecutive days in the treatment of diabetic peripheral neuropathy. The study plans to enroll 202 patients, who will be randomly assigned in a 1:1 ratio to either the shortwave therapy group (20 minutes daily for five consecutive days) or a sham treatment group with an identical appearance. The primary efficacy endpoint is the remission rate of the Toronto Clinical Scoring System score one month after treatment (a decrease of ≥1 point). Secondary endpoints include short-term efficacy, pain visual analog scale scores, quality of life scores, and safety indicators. The study hypothesizes that shortwave therapy can significantly improve neurological symptoms, with an expected remission rate of 65% in the treatment group and 20% in the control group, with the superiority margin set at 20%. This study will provide high-quality evidence-based medical evidence for the use of shortwave therapy in diabetic peripheral neuropathy.

Вмешательства

• Устройство Short-Wave Diathermy
  Use the CJ270-I model shortwave therapy device from Nanjing Congjing Biotechnology Machinery Co., Ltd. The patient sits, placing both lower limbs into the device, adjust the power to 250W, frequency to 27.12 MHz, once a day, 20 minutes each time, for 5 consecutive days.
• Устройство Placebo treatment group
  Using devices that are completely identical in appearance, the treatment process, screen display, and sounds are the same as the active group, but the devices are specially modified and do not emit electromagnetic energy. To ensure the success of blinding, the skin temperature of the treatment area will be measured before and after treatment, but the specific values will not be disclosed to the subjects.

Первичные конечные точки

• Remission rate of TCSS score [Срок оценки: From enrollment to the end of 4 weeks of treatment]

Вторичные конечные точки (6)

• Change in TCSS from baseline [Срок оценки: Within 5 days and 1 month after treatment]
• Changes in each component of TCSS compared to baseline [Срок оценки: Within 5 days and 1 month after treatment]
• Change in VAS pain score from baseline [Срок оценки: Within 5 days and 1 month after treatment]
• Change in EQ-5D quality of life score from baseline [Срок оценки: Within 5 days and 1 month after treatment]
• Response Rate [Срок оценки: After 5 days of treatment and 1 month later]
• Patient Global Impression of Change (PGIC) [Срок оценки: Within 5 days and 1 month after the treatment]

Критерии участия

Критерии включения

• 1\. Aged 18-85 years, regardless of gender, with the ability to act independently;
• 2\. Appearance of neuropathic symptoms or signs at the time of or after the diagnosis of diabetes, meeting the following criteria: presence of DPN symptoms (numbness, tingling, burning, cold, pain), with or without signs (abnormalities in any of ankle reflex, vibration sense, pinprick sensation, temperature sensation, or pressure sensation);
• 3\. Able to complete the TCSS assessment;
• 4\. Understands the entire trial process, voluntarily participates in the study, and signs the informed consent form.
• 5\. Patients who did not respond to adequate treatment with mecobalamin and other medications.

Критерии исключения

• 1\. Peripheral neuropathy caused by other reasons (such as lumbar spine lesions, vitamin B12 deficiency, uncontrolled hypothyroidism, alcohol intoxication, drug neurotoxicity, Guillain-Barré syndrome, etc.);
• 2\. Hemorrhagic diseases, malignant tumors;
• 3\. History of below-knee amputation;
• 4\. Skin damage, infection at the treatment site, or presence of metal implants, pacemaker;
• 5\. Combined severe heart, liver, or kidney dysfunction (e.g., eGFR < 15 ml/min/1.73m²), or cognitive impairment preventing cooperation;
• 6\. Pregnancy, breastfeeding, or planning pregnancy;
• 7\. Participation in other interventional clinical trials within the past 3 months;
• 8\. Combined severe psychiatric disorders;
• 9\. Other conditions assessed by the investigator that prevent completion of the trial;
• 10\. Poor compliance.

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

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07625007 · 2026-0262-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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