Diabetic Peripheral NeuropathyNCT07625007
Shortwave Intervention for Diabetic Peripheral Neuropathy.
A study testing Short-Wave Diathermy in people with Diabetic Peripheral Neuropathy, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Short-Wave Diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Jinbo Hu, PHD, 15123324001, hujinbo@cqmu.edu.cn
About this study
Official title: 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Short-Wave Diathermy, Placebo treatment group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Wave DiathermyDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Short-Wave Diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of TCSS score
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.
Measured: From enrollment to the end of 4 weeks of treatment
Secondary outcomes (6)
Change in TCSS from baseline
Changes in TCSS from baseline within 5 days after treatment and 1 month later
Measured: Within 5 days and 1 month after treatment
Changes in each component of TCSS compared to baseline
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.
Measured: Within 5 days and 1 month after treatment
Change in VAS pain score from baseline
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.
Measured: Within 5 days and 1 month after treatment
Change in EQ-5D quality of life score from baseline
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.
Measured: 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)
Measured: After 5 days of treatment and 1 month later
Patient Global Impression of Change (PGIC)
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)
Measured: Within 5 days and 1 month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 May 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Qing-feng, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625007
- Sponsor's protocol ID
- 2026-0262-02
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortwave Intervention for Diabetic Peripheral Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial(SIDPN)
- ClinicalTrials.gov ID
- NCT07625007
- Acronym / sponsor ID
- 2026-0262-02
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment group | Sham comparator | Device: Placebo treatment groupUsing 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. |
| Shortwave therapy group | Experimental | Device: Short-Wave DiathermyUsing 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-Wave DiathermyUse 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. | Device | Shortwave therapy group |
| Placebo treatment groupUsing 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 |
Primary outcome
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.
6 secondary outcomes
Change in TCSS from baseline
Time frame: Within 5 days and 1 month after treatment
Changes in each component of TCSS compared to baseline
Time frame: Within 5 days and 1 month after treatment
Change in VAS pain score from baseline
Time frame: Within 5 days and 1 month after treatment
Change in EQ-5D quality of life score from baseline
Time frame: Within 5 days and 1 month after treatment
Response Rate
Time frame: After 5 days of treatment and 1 month later
Patient Global Impression of Change (PGIC)
Time frame: Within 5 days and 1 month after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-Wave Diathermy in people with Diabetic Peripheral Neuropathy, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinbo Hu, PHD (13663758151, hujinbo@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of TCSS score (time frame: From enrollment to the end of 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.