Shortwave therapy for diabetic peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, single-blind, sham-controlled trial at a single center enrolling adults with diabetic peripheral neuropathy. Participants will receive five consecutive days of shortwave diathermy or a sham treatment that looks identical. The primary outcome is the remission rate on the Toronto Clinical Scoring System score one month after treatment. Secondary outcomes include short-term efficacy, pain scores, quality of life, and safety measures. The study plans to enroll about 202 participants to detect a meaningful difference between groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Jinbo Hu, PHD
• Email: hujinbo@cqmu.edu.cn
• Phone: 13663758151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.