Herpes Zoster, Pain, Postherpetic Neuralgia
Conditions
Brief summary
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.
Interventions
DRUGVenlafaxine combined conventional therapy
Venlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.
DRUGConventional therapy
The control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.
Sponsors
Zhongnan Hospital
Jilin Provincial People's Hospital
Beijing Tiantan Hospital
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Ages more than 18 years; * 2\. Patients with onset of HZ rash less than 30 days; * 3\. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain); * 4\. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal; * 5\. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher; * 6\. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Exclusion criteria
* 1\. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ; * 2.Known hypersensitivity to venlafaxine; * 3\. Previous antiviral treatment that did not comply with guideline recommendations; * 4\. History of herpes zoster vaccination before enrollment; * 5.History of major depressive disorder requiring antidepressant therapy; * 6.History of systemic immune diseases, organ transplantation, or cancers; * 7.Pregnancy or lactation; * 8.Presence of acute or chronic pain disorders other than HZ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PHN | at 90 days after rash onset | PHN will be defined as persistent pain in the affected dermatome at 90 days after rash onset that is clinically meaningful, operationalized as an average pain score ≥ 3 on the NRS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The average daily pain intensity | at weeks 1, 2, 4, 8, 12, 24, and 52 | The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain. |
| The worst numeric rating scale score | at weeks 1, 2, 4, 8, 12, 24, and 52 | The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain. |
| Proportion of Patients Achieving Pain Reduction | at weeks 1, 2, 4, 8, 12, 24, and 52 | The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity |
| Average weekly consumption of each analgesic class | at weeks 4, 8, 12, 24, and 52 | — |
| Herpes Zoster Severity of Illness Index | at weeks 1, 2, 4, 8 and 12 | The HZSOI is a severity-by-duration measure of overall pain burden associated with HZ and is typically calculated as the area under the curve of the worst pain scores over a defined period after rash onset. |
| The 12-item Short-Form Health Survey (SF-12) score | at weeks 4, 8, 12, 24, and 52 | The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status. |
| The Medical Outcomes Study Sleep Scale (MOS) | at weeks 4, 8, 12, 24, and 52 | The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence). |
| Adverse events | Through study completion, an average of 52 weeks | The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state. |
| Neuropathic Pain Scale | at or after 90 days following rash onset | Neuropathic pain characteristics will be assessed using the Neuropathic Pain Scale in participants with developing PHN. The Neuropathic Pain Scale consists of 10 numeric rating items, each scored from 0 to 10, with higher scores indicating greater neuropathic pain severity. The scale assesses pain intensity, unpleasantness, and 8 specific pain qualities, including sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain. |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed