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

Dexiong Han

Status: Not yet enrolling

Conditions: Postherpetic Neuralgia ( PHN )

Treatments: Device: Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China); Drug: Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）; Procedure: Streitberger Placebo Needle Set ( Asiamed )

Study type: Interventional

Funder types: Other

Identifiers

NCT06990854

ZSLL-KY-2025-034

Details and patient eligibility

About

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.

Enrollment: 207 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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207 participants in 3 patient groups

Electroacupuncture group

Experimental group

Description:

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 twisting manipulation (90° rotation at 90 cycles/min) until patients felt soreness, numbness, or distension. Electroacupuncture was applied using the Hans-100A device, with dense-disperse wave mode (2/100 Hz) and intensity adjusted to patient tolerance, for 30 minutes. Pharmacological intervention: Identical to the pharmacotherapy group.

Treatment:

Drug: Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）

Device: Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China)

Pharmacotherapy group

Active Comparator group

Description:

In accordance with the Interpretation of the expert consensus on the whole-process management of herpes zoster-associated pain, 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 Mecobalamin tablets: 5 mg three times daily.

Treatment:

Drug: Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）

Sham acupuncture group

Sham Comparator group

Description:

Acupoint prescription: Identical to the electroacupuncture group. Acupuncture procedure: The Streitberger needle, a widely reported placebo needle device in acupuncture RCTs, was applied for sham intervention. Blinding assessments have predominantly demonstrated successful masking outcomes. 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 device is retracted by approximately 1 mm and connected to electroacupuncture apparatus without electrical stimulation activation. Pharmacological intervention: Identical to the pharmacotherapy group.

Treatment:

Procedure: Streitberger Placebo Needle Set ( Asiamed )

Drug: Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）