NCT06990854

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

Not yet recruiting NA Last updated 2 July 2025

What this trial tests

NA trial testing Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China) in Postherpetic Neuralgia ( PHN ) in 207 participants. Not yet recruiting.

Timeline

1 July 2025

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Dexiong Han
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	207
Start date	1 July 2025
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Postherpetic Neuralgia ( PHN ) — all drugs for Postherpetic Neuralgia ( PHN ) →

Sponsor

Dexiong Han

Who can join

Adults 20 to 80, any sex, with Postherpetic Neuralgia ( PHN ). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Assessing the participants' pain intensity by the Numerical Rating Scale
  Time frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
  Pain intensity was assessed using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 ("no pain") to 10 ("intolerable pain"). This validated tool demonstrates rapid clinical utility and robust psychometric properties, including good reliability and validity in pain assessment.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and Safety of Electroacupuncture for Postherpetic Neuralgia and Biomarker Evaluation: A Study Protocol for a Multicenter, Randomized Trial.
   Yu Q, Wang X, Wu J, Zhang Q, et al · · 2025 · cited 1× · PMID 41199896 · DOI 10.2147/jpr.s559309