Shortwave Intervention for Diabetic Peripheral Neuropathy.

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.

NCT Number	NCT07625007
Lead Sponsor	Chongqing Medical University Collaborators: First Affiliated Hospital of Chongqing Medical University
Conditions	Diabetic Peripheral Neuropathy
Enrollment	202 participants
Start Date	2026-05-20
Primary Completion	2027-05-20 (estimated)
Study Completion	2027-05-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-18