Shortwave Intervention for Diabetic Peripheral Neuropathy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short-Wave Diathermy, Placebo treatment group.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)
Overview
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.
Interventions
- Device 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. - 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.
Primary outcome measures
- Remission rate of TCSS score [Time frame: From enrollment to the end of 4 weeks of treatment]
Secondary outcome measures (6)
- Change in TCSS from baseline [Time frame: Within 5 days and 1 month after treatment]
- Changes in each component of TCSS compared to baseline [Time frame: Within 5 days and 1 month after treatment]
- Change in VAS pain score from baseline [Time frame: Within 5 days and 1 month after treatment]
- Change in EQ-5D quality of life score from baseline [Time frame: Within 5 days and 1 month after treatment]
- Response Rate [Time frame: After 5 days of treatment and 1 month later]
- Patient Global Impression of Change (PGIC) [Time frame: Within 5 days and 1 month after the treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
Identifiers
NCT: NCT07625007 · 2026-0262-02