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Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)
Sponsor: Chongqing Medical University
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.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2026-05-20
Completion Date
2027-05-20
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China