Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain
Can a Non-interventional Pulsed Radiofrequency Device Relieve Pain and Improve Function in Patients With Diabetic Neuropathy That Are Refractory to Medication? A Single Blind Randomized Placebo-controlled Trial
The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief.
In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.
調査の概要
状態
詳細な説明
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, often presenting as a chronic, symmetrical, length-dependent sensorimotor polyneuropathy. Patients frequently experience neuropathic pain, hyperalgesia, allodynia, and paraesthesia in the lower extremities. Because pharmacological treatments for painful DPN are often ineffective and complicated by adverse side effects, there is a significant unmet clinical need for alternative, non-pharmacological therapies. This single-blind, randomized, placebo-controlled clinical trial evaluates the efficacy of a transcutaneous electrical pulsed radio frequency (PRF) device in alleviating the pain and sensory symptoms associated with pedal DPN.
Patients diagnosed with pedal DPN who scored 4 or higher on the DN4 neuropathic pain diagnostic test were randomized into two parallel groups: an active treatment group and a placebo group. To ensure successful patient blinding, participants were advised that they might not feel a physical sensation during the treatment, which aligns with the natural sensory loss (numbness/paraesthesia) commonly experienced by this patient population. Care providers and investigators administering the interventions were unblinded.
The treatment protocol involved mapping the sciatic nerve in the popliteal fossa posteriorly at the knee. The active or placebo device was then applied bilaterally at this site for 10 minutes. Interventions were administered once weekly for three consecutive weeks.
Clinical efficacy was assessed using validated patient-reported outcome measures. The primary outcome evaluated changes in neuropathic pain and symptoms using the DN4 test, while the secondary outcome measured pain severity and interference with daily life using the Brief Pain Inventory-Short Form (BPI-SF). Data was collected at baseline, immediately following the third treatment, and at subsequent follow-up visits at 1, 3, and 6 months to evaluate both immediate and sustained therapeutic effects.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Gauteng
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Johannesburg、Gauteng、南アフリカ
- Centre for Diabetes and Endocrinology (CDE), Houghton
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Johannesburg、Gauteng、南アフリカ
- Clinical Sites - West Johannesburg
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Johannesburg、Gauteng、南アフリカ
- Diabetic Clinic at the Charlotte Maxeke Hospital
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Krugersdorp、Gauteng、南アフリカ
- Clinical Sites - Krugersdorp
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Pretoria、Gauteng、南アフリカ
- CDE / Clinical Sites - Pretoria
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参加基準
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
説明
Inclusion Criteria:
- Diagnosis of pedal Diabetic Peripheral Neuropathy.
- A score of 4 or greater than 4/10 on the DN4 Test.
- Naive to (no previous experience with) the electrical pulsed radio frequency current treatment.
Exclusion Criteria:
- Current pregnancy.
- Presence of a pacemaker.
- Presence of a peripheral or spinal cord stimulator.
- Presence of metal implants in the knee and/or hip.
研究計画
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group A: Active Transcutaneous Pulsed Radio Frequency
Patients in this group received the active electrical pulsed radiofrequency current treatment.
The device was applied bilaterally at the sciatic nerve in the popliteal fossa.
Each treatment session lasted for 10 minutes.
The intervention was administered once weekly for three consecutive weeks.
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Active transcutaneous electrical pulsed radio frequency stimulation.
The device is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks.
他の名前：
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偽コンパレータ：Group B: Placebo / Sham Device
Patients in this group received a placebo (sham) treatment designed to mimic the active device.
The placebo device was applied bilaterally at the sciatic nerve in the popliteal fossa.
Each placebo session lasted for 10 minutes.
The sham intervention was administered once weekly for three consecutive weeks.
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A sham device designed to look and operate like the active device but delivering no therapeutic current.
It is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks to mimic the active treatment.
他の名前：
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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 |
|---|---|---|
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Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test
時間枠：Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.
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The DN4 (Douleur Neuropathique 4) questionnaire is a screening tool used to identify neuropathic pain and symptoms.
It consists of 7 subjective questions regarding sensory symptoms (e.g., burning, painful cold, electric shocks, tingling, pins and needles, numbness) and 3 objective tests (hypoesthesia to touch, pinprick, and tactile allodynia).
The maximum score is 10 points.
A score of 4 or greater out of 10 represents a positive diagnosis of neuropathic pain.
Higher scores indicate a greater severity of neuropathic pain and symptoms.
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Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
時間枠：Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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The BPI-SF is a validated patient-reported questionnaire that evaluates pain.
This outcome focuses on the Pain Severity subscale, which assesses worst, least, average, and present pain using an 11-point numerical rating scale.
Scores range from 0 to 10, where 0 equals "no pain" and 10 equals "pain as bad as you can imagine".
Higher scores indicate greater pain severity.
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Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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Change in Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
時間枠：Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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The BPI-SF also evaluates how much pain interferes with various aspects of the patient's daily life.
This includes general activities, work, sleep, walking ability, mood, relations with other people, and overall quality of life.
Interference is measured using an 11-point numerical rating scale ranging from 0 to 10, where 0 equals "does not interfere" and 10 equals "completely interferes".
Higher scores indicate greater interference with daily functioning.
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Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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協力者と研究者
捜査官
- 主任研究者：Phyllis P Berger、Faculty: University of the Witwatersrand
- スタディディレクター：Stanley S Landau、Centre for Diabetes and Endocrinology (CDE)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- M161037
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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