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Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Recent attention has focused on the potential role of muscle relaxant, which can relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions. Therefore, investigators hypothesize that baclofen may effectively reduce the severity of HZ pain without significantly increasing adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen combined with conventional therapy group | Experimental |
| |
| Conventional therapy group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen combined conventional therapy | Drug | In the baclofen combined conventional therapy group, baclofen will be initiated at 15 mg daily. Then, based on the patient's response, the single dose can be gradually increased by 5mg each time, with a three-day interval. The maximum recommended dose is 30~75mg daily. In addition, the group will contain conventional treatment for HZ, except baclofen, including NSAIDs, opioids, antiviral drugs and so on. |
| Measure | Description | Time Frame |
|---|---|---|
| the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days. | 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. | At week 4 after experimental drug medication |
| Measure | Description | Time Frame |
|---|---|---|
| The worst numeric rating scale score | 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. | at weeks 1, 2, 4, 8, and 12 after experimental drug medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Beijing, Beijing 100070 | Recruiting | Beijing | China |
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| Label | URL |
|---|---|
| Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107. | View source |
| Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46. | View source |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Conventional therapy | Drug | In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on. |
|
| Proportion of Patients Achieving Pain Reduction |
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity |
| at weeks 1, 2, 4, 8, and 12 after experimental drug medication |
| Proportion of patients developing postherpetic neuralgia | at week 12 after experimental drug medication |
| The type of analgesics and average weekly consumption per analgesics | at weeks 4, 8, and 12 after experimental drug medication |
| The 12-item Short-Form Health Survey (SF-12) score | 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. | at weeks 4, 8, and 12 after experimental drug medication |
| The Medical Outcomes Study Sleep Scale (MOS) | 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). | at weeks 4, 8, and 12 after experimental drug medication |
| Adverse events | 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. | Through study completion, an average of 12 weeks |
| D007239 | Infections |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |