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

July 2, 2025 updated by: Dexiong Han

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture group

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.
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.
Active Comparator: Pharmacotherapy group
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.
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.
Sham Comparator: Sham acupuncture group

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of pain episodes in the past 24 hours
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Daily documentation of pain episodes over 24-hour intervals to characterize symptom fluctuation patterns.
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 )
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Hamilton Anxiety Scale36 (HAMA): A 14-item clinician-administered tool evaluating anxiety severity across domains such as anxious mood, tension, and insomnia. Scores ≥14 indicate clinically significant anxiety.
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)
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

Hamilton Depression Scale37 (HAMD-21): A 21-item instrument assessing core depressive symptoms spanning affective, cognitive, and somatic dimensions.

Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
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
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
The Short-Form 36 Health Survey (SF-36) quantified health-related quality of life across 8 domains (e.g., physical function, social role). This instrument has been extensively validated in chronic pain research.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Inflammatory Markers : TNF-α
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
TNF-α, a proinflammatory cytokine.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Inflammatory Markers : IL-10
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
IL-10, an anti-inflammatory cytokine.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Neuroregeneration Indicators: Substance P (SP)
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Substance P (SP), a tachykinin modulating nociceptive signaling.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Neuroregeneration Indicators: Neuropeptide Y (NPY)
Time Frame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Neuropeptide Y (NPY) , a mediator of neuro-immune crosstalk and synaptic remodeling.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dexiong Han

Collaborators

The Third People's Hospital of Hangzhou
Changxing County Traditional Chinese Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 17, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSLL-KY-2025-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postherpetic Neuralgia ( PHN )

Clinical Trials on Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China)

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