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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
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.
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
RECRUITINGthe 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.
Time frame: At week 4 after experimental drug medication
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.
Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication
Proportion of Patients Achieving Pain Reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity
Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication
Proportion of patients developing postherpetic neuralgia
Time frame: at week 12 after experimental drug medication
The type of analgesics and average weekly consumption per analgesics
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Through study completion, an average of 12 weeks
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