The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster (NCT05348382) | Clinical Trial Compass
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The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster
China72 participantsStarted 2022-07-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain intensity
Timeframe: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
2
Stopping time of herpes zoster
Timeframe: through study completion (up to 4 months)
3
Crusting time of herpes zoster
Timeframe: through study completion (up to 4 months)
4
Removal time of herpes zoster scabs
Timeframe: through study completion (up to 4 months)
5
Change in the temperature of regions of interest (ROIs)
Timeframe: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
6
Incidence rate of postherpetic neuralgia (PHN)
Timeframe: at 3-month follow-up
Trial details
NCT IDNCT05348382
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University
. 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;