The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348382
• Other study ID #: 2022ZB184
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2022
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Lei Wu, MD
• Phone: 18958077903
• Email: 413351308[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Zoster

Intervention

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 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.

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stopping time of herpes zoster	the number of days required for herpes zoster to stop increasing	through study completion (up to 4 months)
Primary	Crusting time of herpes zoster	the number of days required for herpes zoster crusting	through study completion (up to 4 months)
Primary	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)
Primary	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
Primary	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	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
Secondary	Adverse events	Incidence of adverse events	through study completion (up to 4 months)