Shortwave Intervention for Diabetic Peripheral Neuropathy.
2026年6月16日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
202
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jinbo Hu, PHD
- 電話番号：13663758151
- メール：hujinbo@cqmu.edu.cn
研究場所
-
-
-
Chongqing、中国
- 募集
- The First Affiliated Hospital of Chongqing Medical University
-
コンタクト：
- Jinbo Hu, PHD
- 電話番号：15123324001
- メール：hujinbo@cqmu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：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.
|
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.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Remission rate of TCSS score
時間枠：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.
|
From enrollment to the end of 4 weeks of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in TCSS from baseline
時間枠：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
|
|
Response Rate
時間枠：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
|
|
Changes in each component of TCSS compared to baseline
時間枠：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.
|
Within 5 days and 1 month after treatment
|
|
Change in VAS pain score from baseline
時間枠：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.
|
Within 5 days and 1 month after treatment
|
|
Change in EQ-5D quality of life score from baseline
時間枠：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.
|
Within 5 days and 1 month after treatment
|
|
Patient Global Impression of Change (PGIC)
時間枠：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)
|
Within 5 days and 1 month after the treatment
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月20日
一次修了 (推定)
2027年5月20日
研究の完了 (推定)
2027年5月20日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-0262-02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。