Shortwave Intervention for Diabetic Peripheral Neuropathy.
2026年6月16日 更新者：Cheng Qing-feng、Chongqing Medical University
Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)
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.
研究概览
研究类型
介入性
注册 (估计的)
202
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jinbo Hu, PHD
- 电话号码：13663758151
- 邮箱：hujinbo@cqmu.edu.cn
学习地点
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Chongqing、中国
- 招聘中
- The First Affiliated Hospital of Chongqing Medical University
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接触：
- Jinbo Hu, PHD
- 电话号码：15123324001
- 邮箱：hujinbo@cqmu.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：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.
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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.
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实验性的：Shortwave therapy group
Using the CJ270-I model shortwave therapy instrument from Nanjing Congjing Biological Machinery Co., Ltd.
Patients took a sitting position, placed both lower limbs into the therapy instrument, adjusted the power to 250W, frequency to 27.12MHz, once daily, 20 minutes each time, for 5 consecutive days.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Remission rate of TCSS score
大体时间：From enrollment to the end of 4 weeks of treatment
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The Toronto Clinical Scoring System (TCSS) assesses neuropathy symptoms, sensory deficits, and reflexes, with a total score ranging from 0 to 19.
Higher scores indicate worse outcomes (more severe neuropathy).
Remission is defined as a decrease of 1 point or more from baseline.
This outcome is compared between the shortwave therapy group and the sham treatment group.
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From enrollment to the end of 4 weeks of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in TCSS from baseline
大体时间：Within 5 days and 1 month after treatment
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Changes in TCSS from baseline within 5 days after treatment and 1 month later
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Within 5 days and 1 month after treatment
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Response Rate
大体时间：After 5 days of treatment and 1 month later
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Response rates of each indicator (TCSS, VAS) after 5 days and 1 month of treatment (defined as the proportion of patients with ≥30% improvement from baseline)
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After 5 days of treatment and 1 month later
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Changes in each component of TCSS compared to baseline
大体时间：Within 5 days and 1 month after treatment
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Changes in each component of the Toronto Clinical Scoring System (TCSS) from baseline.
The TCSS assesses three components: symptoms, sensory deficits, and reflexes.
Total score range: 0 to 19 Each component has its own sub-score range (symptoms: 0-6, sensory: 0-5, reflexes: 0-8) Higher scores indicate worse outcomes (more severe neuropathy) This outcome measures the within-group change from baseline at each follow-up time point.
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Within 5 days and 1 month after treatment
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Change in VAS pain score from baseline
大体时间：Within 5 days and 1 month after treatment
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Visual Analogue scale（VAS）Score range: 0-10 Higher scores indicate worse outcomes (more severe pain) This outcome measures the within-group change from baseline at each follow-up time point.
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Within 5 days and 1 month after treatment
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Change in EQ-5D quality of life score from baseline
大体时间：Within 5 days and 1 month after treatment
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Changes in the EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) from baseline.
The EQ-5D-5L consists of two components: 1. Utility index score: Derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) Score range typically from ≤ 0 (worst health state) to 1 (full health) Higher scores indicate better outcomes 2. EQ-VAS (Visual Analogue Scale): Self-rated overall health on a vertical scale Score range: 0 (worst imaginable health) to 100 (best imaginable health) Higher scores indicate better outcomes This outcome measures the within-group change from baseline at each follow-up time point.
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Within 5 days and 1 month after treatment
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Patient Global Impression of Change (PGIC)
大体时间：Within 5 days and 1 month after the treatment
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Patients' self-assessment of overall change in their condition since the start of treatment, measured by the Patient Global Impression of Change (PGIC) scale.
The PGIC is a 7-point rating scale: Score range: 1 to 7 Scoring: 1 = Very much better 2 = Much better 3 = A little better 4 = No change 5 = A little worse 6 = Much worse 7 = Very much worse Lower scores indicate better outcomes (greater improvement)
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Within 5 days and 1 month after the treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月20日
初级完成 (估计的)
2027年5月20日
研究完成 (估计的)
2027年5月20日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026-0262-02
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