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

29. maj 2026 opdateret af: Cheng Qing-feng, Chongqing Medical University
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

202

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Chongqing, Kina
        • Rekruttering
        • The First Affiliated Hospital of Chongqing Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: 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.
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Remission rate of TCSS score
Tidsramme: From enrollment to the end of 4 weeks of treatment
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in TCSS from baseline
Tidsramme: Within 5 days and 1 month after treatment
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
Tidsramme: Within 5 days and 1 month after treatment
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
Tidsramme: Within 5 days and 1 month after treatment
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
Tidsramme: Within 5 days and 1 month after treatment
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
Tidsramme: 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)
After 5 days of treatment and 1 month later

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chongqing Medical University

Samarbejdspartnere

First Affiliated Hospital of Chongqing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. maj 2026

Primær færdiggørelse (Anslået)

20. maj 2027

Studieafslutning (Anslået)

20. maj 2027

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026-0262-02

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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