The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

Last updated: July 14, 2022
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Shingles

Treatment

N/A

Clinical Study ID

NCT05348382
2022ZB184
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants have confirmed diagnosis of herpes zoster;
  2. Herpes zoster is in the acute stage and participants have not yet received antiviraltreatment or analgesic treatment;
  3. 18≤Age≤80 years, regardless of gender;
  4. Significant pain with a visual analog scale (VAS) score ≥ 4;
  5. Absence of other diseases causing skin temperature change;
  6. Participants can understand the study procedure and agree to sign the informed consentform.

Exclusion

Exclusion Criteria:

  1. Participants have some specific types of herpes zoster, such as disseminated herpeszoster; or herpes zoster is located on regions that are not suitable for intradermalacupuncture, such as the head, face, or perineum.
  2. Pregnant or lactating subjects;
  3. Participants have scar constitution or have severe cardiovascular, hepatic, renal, andhematopoietic system diseases that result in bleeding tendency, thereby making themunsuitable for intradermal acupuncture;
  4. Participants with severe cognitive impairment who are unable to fully understand thetrial protocol;
  5. Participants are taking part in other trials.

Study Design

Total Participants: 72
Study Start date:
July 04, 2022
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • the Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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