About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Ages more than 18 years;

2. Patients with onset of HZ rash less than 90 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;

Disqualifiers

1. History of taking baclofen;

2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;

3. History of intolerance or hypersensitivity to any active components or excipient of the baclofen;

4. History of systemic immune diseases, organ transplantation, or cancers;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Conventional therapy
Drug
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Treatment groups

750 Participants

are divided into 2 treatment groups

Group A: Baclofen combined with conventional therapy groupExperimental treatment 1 intervention

Group B: Conventional therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

At week 4 after experimental drug medication

Secondary outcomes

1

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

2

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

3

Proportion of patients developing postherpetic neuralgia

Time frame

at week 12 after experimental drug medication

4

The type of analgesics and average weekly consumption per analgesics

Time frame

at weeks 4, 8, and 12 after experimental drug medication

The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts