The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

Not Applicable

Recruiting

• Conditions: Herpes Zoster
• Interventions: Procedure: Intradermal acupuncture; Procedure: Sham intradermal acupuncture

• Registration Number: NCT05348382
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

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.

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 Timeline

• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Status Verified: 2022-07
• Study Start: 2022-07-04
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Removal time of herpes zoster scabs	through study completion (up to 4 months)	the number of days required for all herpes zoster scabs to be completely shed
Change in pain intensity	at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up	The pain intensity is assessed using the 10-point Visual Analog Scale (VAS)
Stopping time of herpes zoster	through study completion (up to 4 months)	the number of days required for herpes zoster to stop increasing
Incidence rate of postherpetic neuralgia (PHN)	at 3-month follow-up	The incidence rate of PHN will be assessed by calculating the percentage of patients who suffer from PHN
Crusting time of herpes zoster	through study completion (up to 4 months)	the number of days required for herpes zoster crusting
Change in the temperature of regions of interest (ROIs)	at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up	The temperature of ROIs will be assessed by infrared thermography.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China

the Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China