Clinical trial NCT06990854: Acupuncture for Postherpetic Neuralgia
Official title: Acupuncture for Postherpetic Neuralgia and the Correlation With Serum Biomarkers: A Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postherpetic Neuralgia ( PHN )
Keywords: acupuncture
Postherpetic Neuralgia
serum biomarkers
serum substance P
Neuropeptide Y
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Third People's Hospital of Hangzhou
name: Changxing County Traditional Chinese Medicine Hospital
First posted: 2025-05-25
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessing the participants' pain intensity by the Numerical Rating Scale
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Secondary outcomes:
measure: The number of pain episodes in the past 24 hours
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Psychological Status Assessment: Hamilton Anxiety Scale 36 ( HAMA )
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Psychological Status Assessment: Hamilton Depression Scale37 (HAMD-21)
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: The health-related quality of participants' life is assessed by The Short-Form 36 Health Survey
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Neuroregeneration Indicators: Neuropeptide Y (NPY)
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Neuroregeneration Indicators: Substance P (SP)
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Inflammatory Markers : TNF-α
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
measure: Inflammatory Markers : IL-10
timeFrame: Assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References: