RecruitingNot Applicable

Shortwave Intervention for Diabetic Peripheral Neuropathy.

China202 participantsStarted 2026-05-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 investigat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Remission rate of TCSS score

Timeframe: From enrollment to the end of 4 weeks of treatment

Trial details

NCT IDNCT07625007

SponsorChongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-20

Contact for this trial

Jinbo Hu, PHD

13663758151 hujinbo@cqmu.edu.cn

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials