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Postherpetic Neuralgia ( PHN )NCT06990854

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

A study testing Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China) and Pharmacotherapy:① Pregabalin ( Lyrica™ ,Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets, Weicai (China) Pharmaceutical Co., Ltd, China) in people with Postherpetic Neuralgia ( PHN ), run by Dexiong Han at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Postherpetic Neuralgia ( PHN )
What is being tested?
Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China) and Pharmacotherapy:① Pregabalin ( Lyrica™ ,Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets, Weicai (China) Pharmaceutical Co., Ltd, China)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
1 siteChina
Study dates
1 Jul 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310005

    Dexiong Han, 86+15306561572, han_0213@163.com

    Qintao Yu, 86+17857114233, 3435566202@qq.com

Other trials in China

About this study

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.

Read more

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.

Being 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 )
Keywords
acupuncture, Postherpetic Neuralgia, serum biomarkers, serum substance P, Neuropeptide Y
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    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.

Study groups in NCT06990854
Study groupRoleWhat they receive
Electroacupuncture groupExperimentalAcupoint 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.
Receives: 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)
Pharmacotherapy groupActive comparatorIn 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.
Receives: Drug: Pharmacotherapy:① Pregabalin ( Lyrica™ ,Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets, Weicai (China) Pharmaceutical Co., Ltd, China)
Sham acupuncture groupSham comparatorAcupoint 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.
Receives: Drug: Pharmacotherapy:① Pregabalin ( Lyrica™ ,Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets, Weicai (China) Pharmaceutical Co., Ltd, China); Procedure: Streitberger Placebo Needle Set ( Asiamed )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing the participants' pain intensity by the Numerical Rating Scale

    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.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

Secondary outcomes (8)
  1. The number of pain episodes in the past 24 hours

    Daily documentation of pain episodes over 24-hour intervals to characterize symptom fluctuation patterns.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  2. Psychological Status Assessment: Hamilton Anxiety Scale 36 ( HAMA )

    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.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  3. Psychological Status Assessment: Hamilton Depression Scale37 (HAMD-21)

    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.

    Measured: 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

    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.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  5. Neuroregeneration Indicators: Neuropeptide Y (NPY)

    Neuropeptide Y (NPY) , a mediator of neuro-immune crosstalk and synaptic remodeling.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  6. Neuroregeneration Indicators: Substance P (SP)

    Substance P (SP), a tachykinin modulating nociceptive signaling.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  7. Inflammatory Markers : TNF-α

    TNF-α, a proinflammatory cytokine.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

  8. Inflammatory Markers : IL-10

    IL-10, an anti-inflammatory cytokine.

    Measured: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
207 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06990854
Sponsor's protocol ID
ZSLL-KY-2025-034
Status last verified
Apr 2025
First submitted
9 May 2025
Last updated
9 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yu Q, Wang X, Wu J, Zhang Q, Ying X, Ou L, Hu H, He K, Wu L, Jin Z, Shentu J, Dai H, Ma R, Hu Q, Han D. Efficacy and Safety of Electroacupuncture for Postherpetic Neuralgia and Biomarker Evaluation: A Study Protocol for a Multicenter, Randomized Trial. J Pain Res. 2025 Nov 1;18:5753-5768. doi: 10.2147/JPR.S559309. eCollection 2025.

    PubMed 41199896

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture (Hans-100A, Nanjing Jisheng Medical Technology, China) and Pharmacotherapy:① Pregabalin ( Lyrica™ ,Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets, Weicai (China) Pharmaceutical Co., Ltd, China) in people with Postherpetic Neuralgia ( PHN ), run by Dexiong Han at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dexiong Han (86+15306561572, han_0213@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06990854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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