The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

Study Overview
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Brief Summary
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Herpes zoster (HZ), also commonly known as shingles, is characterized by a bandlike rash in the dermatome that corresponds to the affected nerve. Pain is prevalent in HZ patients, which may be provoked by light touch. Postherpetic neuralgia (PHN) is one of the most common complications of HZ and it is generally intractable to treat. At present, common treatment methods for HZ include anti-inflammatory, antiviral, analgesic, and neuroleptic regimens. Nevertheless, the application of these therapies can sometimes be limited by side effects. In this scenario, it is urgent to seek alternative non-pharmacological therapies for treating HZ. Intradermal acupuncture (IDA) is a common type of acupuncture. By retaining the needles for a much longer duration than other common modalities of acupuncture, IDA can prolong the sustained effect of acupuncture. In addition, characterized by mild pain during the insertion of intradermal needles, IDA is more suitable for patients who fear conventional acupuncture and it is also easy to operate by practitioners. Therefore, concerning the treatment of pain conditions, such as acute HZ, it may have certain advantages over conventional acupuncture. Thus, The aim of this trial is to evaluate the efficacy and safety of IDA for acute HZ.

Detailed Description
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This randomized controlled trial will enroll 72 eligible patients with acute herpes zoster. Participants who are confirmed eligibility will be randomly allocated to either the IDA group or the sham IDA group in a 1:1 ratio. The duration of the trial will include two study phases, including a 1-month intervention phase and a 3-month follow-up phase.

Official Title
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The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial

Conditions
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Herpes Zoster

Intervention / Treatment
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* Procedure: Intradermal acupuncture
* Procedure: Sham intradermal acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants have confirmed diagnosis of herpes zoster; Herpes zoster is in the acute stage and participants have not yet received antiviral treatment or analgesic treatment; 18≤Age≤80 years, regardless of gender; Significant pain with a visual analog scale (VAS) score ≥ 4; Absence of other diseases causing skin temperature change; Participants can understand the study procedure and agree to sign the informed consent form. Exclusion Criteria: Participants have some specific types of herpes zoster, such as disseminated herpes zoster; or herpes zoster is located on regions that are not suitable for intradermal acupuncture, such as the head, face, or perineum. Pregnant or lactating subjects; Participants have scar constitution or have severe cardiovascular, hepatic, renal, and hematopoietic system diseases that result in bleeding tendency, thereby making them unsuitable for intradermal acupuncture; Participants with severe cognitive impairment who are unable to fully understand the trial protocol; Participants are taking part in other trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradermal acupuncture group<br>Points around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. | Procedure: Intradermal acupuncture<br>* In addition to basis standard pharmacological treatments, intradermal needles will be inserted in each selected acupoint and retained in place for 48 hours. Points around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. The operator will tear off the adhesive tape of intradermal needles and stick them on the selected acupoints, and then apply pressure on intradermal needles over the selected acupoints perpendicularly according to the patient's tolerance. In addition, patients will be instructed to press the intradermal needles 4 times per 24 hours throughout the needle retention period, with the aim to increase stimulation for treatment enhancement, each time lasting around 30 seconds.<br>|
| Sham Comparator: Sham intradermal acupuncture group<br>Sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. | Procedure: Sham intradermal acupuncture<br>* In addition to basis standard pharmacological treatments, sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. Additionally, participants in the sham intradermal acupuncture group will be treated in another room to avoid direct communications with subjects in the IDA group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | The pain intensity is assessed using the 10-point Visual Analog Scale (VAS) | at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up | 
| Stopping time of herpes zoster | the number of days required for herpes zoster to stop increasing | through study completion (up to 4 months) | 
| Crusting time of herpes zoster | the number of days required for herpes zoster crusting | through study completion (up to 4 months) | 
| Removal time of herpes zoster scabs | the number of days required for all herpes zoster scabs to be completely shed | through study completion (up to 4 months) | 
| Change in the temperature of regions of interest (ROIs) | The temperature of ROIs will be assessed by infrared thermography. | at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up | 
| Incidence rate of postherpetic neuralgia (PHN) | The incidence rate of PHN will be assessed by calculating the percentage of patients who suffer from PHN | at 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | The 36-item Short Form Health Survey (SF-36) will be utilized to assess the quality of life. | at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up | 
| Adverse events | Incidence of adverse events | through study completion (up to 4 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herpes zoster, intradermal acupuncture, infrared thermography, clinical trial