Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: Placebo treatment group; Device: Short-Wave Diathermy

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinbo Hu, PHD; Phone Number: 13663758151; Email: hujinbo@cqmu.edu.cn

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Jinbo Hu, PHD; Phone Number: 15123324001; Email: hujinbo@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	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.
Experimental: Shortwave therapy group; Using the CJ270-I model shortwave therapy instrument from Nanjing Congjing Biological Machinery Co., Ltd. Patients took a sitting position, placed both lower limbs into the therapy instrument, adjusted the power to 250W, frequency to 27.12MHz, once daily, 20 minutes each time, for 5 consecutive days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission rate of TCSS score	After 5 consecutive days of shortwave therapy in DPN patients, compared with the sham treatment group, the remission rate of TCSS scores at 1 month (defined as a score decrease of 1 point or more as remission).	From enrollment to the end of 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TCSS from baseline	Changes in TCSS from baseline within 5 days after treatment and 1 month later	Within 5 days and 1 month after treatment
Changes in each component of TCSS compared to baseline	Changes in each component of TCSS from baseline within 5 days after treatment and 1 month later	Within 5 days and 1 month after treatment
Change in VAS pain score from baseline	Changes in VAS pain scores compared to baseline after 5 days and 1 month of treatment	Within 5 days and 1 month after treatment
Change in EQ-5D quality of life score from baseline	Changes in EQ-5D quality of life scores compared to baseline after 5 days and 1 month of treatment;	Within 5 days and 1 month after treatment
Response Rate	Response rates of each indicator (TCSS, VAS) after 5 days and 1 month of treatment (defined as the proportion of patients with ≥30% improvement from baseline)	After 5 days of treatment and 1 month later

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Collaborators: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-0262-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No