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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo treatment group | Sham Comparator | 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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| Shortwave therapy group | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-Wave Diathermy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of TCSS score | 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. | From enrollment to the end of 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TCSS from baseline | Changes in TCSS from baseline within 5 days after treatment and 1 month later | Within 5 days and 1 month after treatment |
| Changes in each component of TCSS compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinbo Hu, PHD | Contact | 13663758151 | hujinbo@cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| Placebo treatment group | Device | 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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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.
| Within 5 days and 1 month after treatment |
| Change in VAS pain score from baseline | 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. | Within 5 days and 1 month after treatment |
| Change in EQ-5D quality of life score from baseline | 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. | Within 5 days and 1 month after treatment |
| Response Rate | 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) | After 5 days of treatment and 1 month later |
| Patient Global Impression of Change (PGIC) | 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) | Within 5 days and 1 month after the treatment |