Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol
1 other identifier
interventional
207
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 9, 2025
April 1, 2025
1.4 years
May 9, 2025
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Secondary Outcomes (8)
The number of pain episodes in the past 24 hours
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 )
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)
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
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Neuroregeneration Indicators: Neuropeptide Y (NPY)
Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
- +3 more secondary outcomes
Study Arms (3)
Electroacupuncture group
EXPERIMENTALAcupoint 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.
Pharmacotherapy group
ACTIVE 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.
Sham acupuncture group
SHAM 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria for PHN;
- Age between 20 and 80 years old;
- Voluntarily participate in the trial and sign the informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dexiong Hanlead
- The Third People's Hospital of Hangzhoucollaborator
- Changxing County Traditional Chinese Medicine Hospitalcollaborator
Study Sites (1)
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310005, China
Related Publications (1)
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.
PMID: 41199896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Traditional Chinese Medicine Physician
Study Record Dates
First Submitted
May 9, 2025
First Posted
May 25, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 9, 2025
Record last verified: 2025-04