Clinical trial NCT05348382: The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster
Official title: The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herpes Zoster
Keywords: herpes zoster
intradermal acupuncture
infrared thermography
clinical trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity
timeFrame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
measure: Stopping time of herpes zoster
timeFrame: through study completion (up to 4 months)
measure: Crusting time of herpes zoster
timeFrame: through study completion (up to 4 months)
measure: Removal time of herpes zoster scabs
timeFrame: through study completion (up to 4 months)
measure: Change in the temperature of regions of interest (ROIs)
timeFrame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
measure: Incidence rate of postherpetic neuralgia (PHN)
timeFrame: at 3-month follow-up
Secondary outcomes:
measure: Change in quality of life
timeFrame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
measure: Adverse events
timeFrame: through study completion (up to 4 months)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Hantong Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.