The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Removal time of herpes zoster scabs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Removal time of herpes zoster scabs
时间窗: through study completion (up to 4 months)
the number of days required for all herpes zoster scabs to be completely shed
Change in pain intensity
时间窗: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
The pain intensity is assessed using the 10-point Visual Analog Scale (VAS)
Stopping time of herpes zoster
时间窗: through study completion (up to 4 months)
the number of days required for herpes zoster to stop increasing
Incidence rate of postherpetic neuralgia (PHN)
时间窗: at 3-month follow-up
The incidence rate of PHN will be assessed by calculating the percentage of patients who suffer from PHN
Crusting time of herpes zoster
时间窗: through study completion (up to 4 months)
the number of days required for herpes zoster crusting
Change in the temperature of regions of interest (ROIs)
时间窗: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
The temperature of ROIs will be assessed by infrared thermography.
次要结局
- Change in quality of life(at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up)
- Adverse events(through study completion (up to 4 months))
研究者
Hantong Hu
Attending doctor
The Third Affiliated hospital of Zhejiang Chinese Medical University