The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

NCT ID: NCT05348382

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-12-31

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.

Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intradermal acupuncture group

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.

Group Type EXPERIMENTAL

Intradermal acupuncture

Intervention Type PROCEDURE

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.

Sham intradermal acupuncture group

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

Group Type SHAM_COMPARATOR

Sham intradermal acupuncture

Intervention Type PROCEDURE

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.

Interventions

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Intradermal acupuncture

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.

Intervention Type PROCEDURE

Sham intradermal acupuncture

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Participants have confirmed diagnosis of herpes zoster;
2. Herpes zoster is in the acute stage and participants have not yet received antiviral treatment 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 consent form.

Exclusion Criteria

1. 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.
2. Pregnant or lactating subjects;
3. 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;
4. Participants with severe cognitive impairment who are unable to fully understand the trial protocol;
5. Participants are taking part in other trials.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hantong Hu

Attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hantong Hu, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Wu, MD

Role: CONTACT

18958077903 ext. 86

Dexiong Han, MD

Role: CONTACT

15017541803 ext. 86

Facility Contacts

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Hantong Hu, MD

Role: primary

18667103032 ext. 86

Dexiong Han, MD

Role: backup

15017541803 ext. 86

Hantong Hu

Role: primary

18667103032 ext. 86

References

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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.

Reference Type BACKGROUND
PMID: 34095161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19674449 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37131531 (View on PubMed)

Other Identifiers

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2022ZB184

Identifier Type: -

Identifier Source: org_study_id

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