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

NCT07625007 | Recruiting DMC

• 1 other identifier: 2026-0262-02
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in TCSS from baseline

  Within 5 days and 1 month after treatment

• Changes in each component of TCSS compared to baseline

  Within 5 days and 1 month after treatment

• Change in VAS pain score from baseline

  Within 5 days and 1 month after treatment

• Change in EQ-5D quality of life score from baseline

  Within 5 days and 1 month after treatment

• Response Rate

  After 5 days of treatment and 1 month later

Study Arms (2)

Placebo treatment group

SHAM COMPARATOR

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

Shortwave therapy group

EXPERIMENTAL

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

Interventions

Short-Wave Diathermy DEVICE

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.

Shortwave therapy group

Placebo treatment group DEVICE

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.

Placebo treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-85 years, regardless of gender, with the ability to act independently;
• \. 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);
• \. Able to complete the TCSS assessment;
• \. Understands the entire trial process, voluntarily participates in the study, and signs the informed consent form.

You may not qualify if:

• \. Peripheral neuropathy caused by other reasons (such as lumbar spine lesions, vitamin B12 deficiency, uncontrolled hypothyroidism, alcohol intoxication, drug neurotoxicity, Guillain-Barré syndrome, etc.);
• \. Hemorrhagic diseases, malignant tumors;
• \. History of below-knee amputation;
• \. Skin damage, infection at the treatment site, or presence of metal implants, pacemaker;
• \. Combined severe heart, liver, or kidney dysfunction (e.g., eGFR \< 15 ml/min/1.73m²), or cognitive impairment preventing cooperation;
• \. Pregnancy, breastfeeding, or planning pregnancy;
• \. Participation in other interventional clinical trials within the past 3 months;
• \. Combined severe psychiatric disorders;
• \. Other conditions assessed by the investigator that prevent completion of the trial;
• \. Poor compliance.

Sponsors & Collaborators

• Chongqing Medical University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Central Study Contacts

Jinbo Hu, PHD

CONTACT

13663758151; hujinbo@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

CN (1)