The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Herpes Zoster
• Intervention / Treatment: Procedure: Intradermal acupuncture; Procedure: Sham intradermal acupuncture

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Wu, MD; Phone Number: 86 18958077903; Email: 413351308@qq.com
• Study Contact Backup: Name: Dexiong Han, MD; Phone Number: 86 15017541803; Email: han_0213@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
      • Contact: Hantong Hu; Phone Number: 86 18667103032; Email: 413351308@qq.com
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
      • Contact: Dexiong Han, MD; Phone Number: 86 15017541803; Email: han_0213@163.com
      • Contact: Hantong Hu, MD; Phone Number: 86 18667103032; Email: thevervecn@163.com
      • Principal Investigator: Hantong Hu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Sham Comparator: Sham intradermal acupuncture group; Sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	The 36-item Short Form Health Survey (SF-36) will be utilized to assess the quality of life.	at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
Adverse events	Incidence of adverse events	through study completion (up to 4 months)

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Hantong Hu, MD, The Third Affiliated hospital of Zhejiang Chinese Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: clinical trial; herpes zoster; intradermal acupuncture; infrared thermography
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex
• Other Study ID Numbers: 2022ZB184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No