Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07625007

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location status: Recruiting

Location contact

Jinbo Hu, PHD

CONTACT

[email protected]

15123324001

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Remission rate of TCSS score

    Time frame: From enrollment to the end of 4 weeks of treatment

    The Toronto Clinical Scoring System (TCSS) assesses neuropathy symptoms, sensory deficits, and reflexes, with a total score ranging from 0 to 19. Higher scores indicate worse outcomes (more severe neuropathy). Remission is defined as a decrease of 1 point or more from baseline. This outcome is compared between the shortwave therapy group and the sham treatment group.

Secondary outcomes

  1. Change in TCSS from baseline

    Time frame: Within 5 days and 1 month after treatment

    Changes in TCSS from baseline within 5 days after treatment and 1 month later

  2. Changes in each component of TCSS compared to baseline

    Time frame: Within 5 days and 1 month after treatment

    Changes in each component of the Toronto Clinical Scoring System (TCSS) from baseline. The TCSS assesses three components: symptoms, sensory deficits, and reflexes. Total score range: 0 to 19 Each component has its own sub-score range (symptoms: 0-6, sensory: 0-5, reflexes: 0-8) Higher scores indicate worse outcomes (more severe neuropathy) This outcome measures the within-group change from baseline at each follow-up time point.

  3. Change in VAS pain score from baseline

    Time frame: Within 5 days and 1 month after treatment

    Visual Analogue scale（VAS）Score range: 0-10 Higher scores indicate worse outcomes (more severe pain) This outcome measures the within-group change from baseline at each follow-up time point.

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

    Time frame: Within 5 days and 1 month after treatment

    Changes in the EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) from baseline. The EQ-5D-5L consists of two components: 1. Utility index score: Derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) Score range typically from ≤ 0 (worst health state) to 1 (full health) Higher scores indicate better outcomes 2. EQ-VAS (Visual Analogue Scale): Self-rated overall health on a vertical scale Score range: 0 (worst imaginable health) to 100 (best imaginable health) Higher scores indicate better outcomes This outcome measures the within-group change from baseline at each follow-up time point.

  5. Response Rate

    Time frame: After 5 days of treatment and 1 month later

    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)

  6. Patient Global Impression of Change (PGIC)

    Time frame: Within 5 days and 1 month after the treatment

    Patients' self-assessment of overall change in their condition since the start of treatment, measured by the Patient Global Impression of Change (PGIC) scale. The PGIC is a 7-point rating scale: Score range: 1 to 7 Scoring: 1 = Very much better 2 = Much better 3 = A little better 4 = No change 5 = A little worse 6 = Much worse 7 = Very much worse Lower scores indicate better outcomes (greater improvement)

Study contacts

Contact information is provided by the study sponsor or research team.

Jinbo Hu, PHD

CONTACT

[email protected]

13663758151

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.