Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol

Обзор

The investigators are conducting a clinical study with the following objectives: to evaluate the clinical efficacy of electroacupuncture combined with pregabalin in treating Postherpetic Neuralgia(PHN); to investigate the correlation between serum biomarker levels and pain symptoms;and to determine whether serum biomarkers can serve as prognostic indicators for PHN. This study utilizes a randomized controlled trial design with assessor blinding. A total of 207 eligible PHN patients were randomly assigned to three groups in a 1:1:1 ratio: the electroacupuncture group, the pharmacotherapy group, and the sham acupuncture group. Comparative analyses of pain intensity and serum biomarker concentrations were conducted across these groups. For the assessment of clinical outcomes, the investigators employed the following measures: the Numerical Rating Scale(NRS), the Hamilton Anxiety Scale(HAMA), the Hamilton Depression Scale(HAMD), the 36-Item Short Form Health Survey(SF-36), serum levels of substance P(SP)and Neuropeptide Y(NPY), and inflammatory markers(IL-10,TNF-α). These assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment. The investigators anticipate that this clinical trial will enhance our understanding of the therapeutic efficacy and underlying mechanisms of acupuncture in managing PHN. It aims to elucidate the relationship between serum biomarkers and the clinical manifestations of PHN, as well as to explore their potential prognostic value in disease outcomes.

Вмешательства

• Устройство Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China)
  Acupoint prescription: The therapeutic protocol utilized Ashi points (localized to herpetic lesion areas) and Jiaji points (EX-B2, ipsilateral to affected dermatomes). Acupuncture procedure: For Ashi points, sterile disposable needles (0.25 mm diameter, 40 mm length) were inserted at a 15° angle to a depth of 15-20 mm, without deqi sensation or manual manipulation. For Jiaji points (EX-B2), needles (0.30 mm diameter, 50 mm length) were inserted perpendicularly to a depth of 40-45 mm, with twist
• Препарат Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）
  Patients received protocol-guided therapy consisting of: ① Pregabalin: Initial dose 75 mg twice daily. Dose may be titrated upward to 150 mg twice daily within one week based on therapeutic response and tolerability. Gradual discontinuation is recommended when clinically appropriate, tapered by 100 mg decrements every 3-7 days. ② Methylcobalamin: 5 mg three times daily.
• Процедура Streitberger Placebo Needle Set ( Asiamed )
  The Streitberger needle, a widely reported placebo needle device in acupuncture RCTs, was applied for sham intervention. This telescoping blunt-tip needle achieves non-penetrating placebo stimulation through its retractable design. Its key advantage lies in evoking a skin-penetrating sensation akin to true needling through tissue compression, while avoiding actual dermal perforation to minimize specific therapeutic effects. Following the perception of needle insertion reported by patients, the d

Первичные конечные точки

• Assessing the participants' pain intensity by the Numerical Rating Scale [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]

Вторичные конечные точки (8)

• The number of pain episodes in the past 24 hours [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Psychological Status Assessment: Hamilton Anxiety Scale 36 ( HAMA ) [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Psychological Status Assessment: Hamilton Depression Scale37 (HAMD-21) [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• The health-related quality of participants' life is assessed by The Short-Form 36 Health Survey [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Neuroregeneration Indicators: Neuropeptide Y (NPY) [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Neuroregeneration Indicators: Substance P (SP) [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Inflammatory Markers : TNF-α [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]
• Inflammatory Markers : IL-10 [Срок оценки: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.]

Критерии участия

Критерии включения

• Meet the diagnostic criteria for PHN;
• Age between 20 and 80 years old;
• Voluntarily participate in the trial and sign the informed consent form.

Критерии исключения

• Pregnant or lactating women;
• Presence of severe liver or kidney dysfunction, malignant tumors, or other serious diseases;
• Presence of hematologic diseases or coagulation disorders;
• Presence of mental illness or other cognitive impairments, unable to understand or unwilling to cooperate with the study requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Публикации

• Yu Q, Wang X, Wu J, Zhang Q, Ying X, Ou L, Hu H, He K, Wu L, Jin Z, Shentu J, Dai H, Ma R, Hu Q, Han D. Efficacy and Safety of Electroacupuncture for Postherpetic Neuralgia and Biomarker Evaluation: A Study Protocol for a Multicenter, Randomized Trial. J Pain Res. 2025 Nov 1;18:5753-5768. doi: 10.2147/JPR.S559309. eCollection 2025. PMID 41199896

Идентификаторы

NCT: NCT06990854 · ZSLL-KY-2025-034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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