NCT05348382

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

April 17, 2022

Last Update Submit

July 14, 2022

Conditions

Herpes Zoster

Keywords

herpes zosterintradermal acupunctureinfrared thermographyclinical trial

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • 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)

Study Arms (2)

Intradermal acupuncture group

EXPERIMENTAL

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

Sham intradermal acupuncture group

SHAM COMPARATOR

Sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling.

Procedure: Sham intradermal acupuncture

Interventions

Intradermal acupuncturePROCEDURE

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.

Intradermal acupuncture group
Sham intradermal acupuncturePROCEDURE

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.

Sham intradermal acupuncture group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • ≤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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

  • Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.

    PMID: 34095161BACKGROUND

  • Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.

    PMID: 19674449BACKGROUND

  • Hu H, Cheng Y, Wu L, Han D, Ma R. Investigating the Therapeutic Effect of Intradermal Acupuncture for Acute Herpes Zoster and Assessing the Feasibility of Infrared Thermography for Early Prediction of Postherpetic Neuralgia: Study Protocol for a Randomized, Sham-Controlled, Clinical Trial. J Pain Res. 2023 Apr 26;16:1401-1413. doi: 10.2147/JPR.S406841. eCollection 2023.

    PMID: 37131531DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Hantong Hu, MD

    The Third Affiliated hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Wu, MD

CONTACT

18958077903413351308@qq.com

Dexiong Han, MD

CONTACT

15017541803han_0213@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 27, 2022

Study Start

July 4, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)