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NCT Number: NCT06990854

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

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.

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Key information

Conditions

Postherpetic Neuralgia ( PHN ) Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310005, China

Location contact

Dexiong Han

CONTACT

[email protected]

86+15306561572

Qintao Yu

CONTACT

[email protected]

86+17857114233

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

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

Drug

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.

Streitberger Placebo Needle Set ( Asiamed )

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dexiong Han

CONTACT

[email protected]

86+15306561572

Qintao Yu

CONTACT

[email protected]

86+17857114233

Sponsors and collaborators

Lead sponsor

Dexiong Han

Other Gov

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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