Diabetic Peripheral Neuropathy
Conditions
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.
Interventions
DEVICEShort-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.
DEVICEPlacebo 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.
Sponsors
Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate of TCSS score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in TCSS from baseline | Within 5 days and 1 month after treatment | Changes in TCSS from baseline within 5 days after treatment and 1 month later |
| Changes in each component of TCSS compared to baseline | 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. |
| Change in VAS pain score from baseline | 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. |
| Change in EQ-5D quality of life score from baseline | 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. |
| Response Rate | 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) |
| Patient Global Impression of Change (PGIC) | 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) |
Countries
China
Contacts
CONTACTJinbo Hu, PHD
Outcome results
None listed