Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Remission rate of TCSS score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Short-Wave Diathermy (Device)
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.
干预措施: Placebo treatment group (Device)
结局指标
主要结局
Remission rate of TCSS score
时间窗: From enrollment to the end of 4 weeks of treatment
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.
次要结局
- Changes in each component of TCSS compared to baseline(Within 5 days and 1 month after treatment)
- Change in VAS pain score from baseline(Within 5 days and 1 month after treatment)
- Change in EQ-5D quality of life score from baseline(Within 5 days and 1 month after treatment)
研究者
Cheng Qing-feng
Professor
Chongqing Medical University