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

NANot yet recruitingINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Postherpetic Neuralgia ( PHN )
Interventions
DEVICE

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 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."

DRUG

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.

PROCEDURE

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 device is retracted by approximately 1 mm and connected to electroacupuncture apparatus without electrical stimulation activation.

Trial Locations (1)

310005

The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou

All Listed Sponsors
collaborator

The Third People's Hospital of Hangzhou

OTHER

collaborator

Changxing County Traditional Chinese Medicine Hospital

UNKNOWN

lead

Dexiong Han

OTHER_GOV

NCT06990854 - Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol | Biotech Hunter | Biotech Hunter