Shortwave Intervention for Diabetic Peripheral Neuropathy.
16 juin 2026 mis à jour par: Cheng Qing-feng, Chongqing Medical University
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
202
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jinbo Hu, PHD
- Numéro de téléphone: 13663758151
- E-mail: hujinbo@cqmu.edu.cn
Lieux d'étude
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Chongqing, Chine
- Recrutement
- The First Affiliated Hospital of Chongqing Medical University
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Contact:
- Jinbo Hu, PHD
- Numéro de téléphone: 15123324001
- E-mail: hujinbo@cqmu.edu.cn
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur factice: 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.
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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.
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Remission rate of TCSS score
Délai: From enrollment to the end of 4 weeks of treatment
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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.
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From enrollment to the end of 4 weeks of treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in TCSS from baseline
Délai: Within 5 days and 1 month after treatment
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Changes in TCSS from baseline within 5 days after treatment and 1 month later
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Within 5 days and 1 month after treatment
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Response Rate
Délai: After 5 days of treatment and 1 month later
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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)
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After 5 days of treatment and 1 month later
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Changes in each component of TCSS compared to baseline
Délai: Within 5 days and 1 month after treatment
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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.
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Within 5 days and 1 month after treatment
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Change in VAS pain score from baseline
Délai: Within 5 days and 1 month after treatment
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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.
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Within 5 days and 1 month after treatment
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Change in EQ-5D quality of life score from baseline
Délai: Within 5 days and 1 month after treatment
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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.
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Within 5 days and 1 month after treatment
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Patient Global Impression of Change (PGIC)
Délai: Within 5 days and 1 month after the treatment
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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)
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Within 5 days and 1 month after the treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 mai 2026
Achèvement primaire (Estimé)
20 mai 2027
Achèvement de l'étude (Estimé)
20 mai 2027
Dates d'inscription aux études
Première soumission
29 mai 2026
Première soumission répondant aux critères de contrôle qualité
29 mai 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026-0262-02
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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