The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- 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
- Crusting time of herpes zoster [through study completion (up to 4 months)]
the number of days required for herpes zoster crusting
- 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 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.
- 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
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants have confirmed diagnosis of herpes zoster;
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Herpes zoster is in the acute stage and participants have not yet received antiviral treatment or analgesic treatment;
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18≤Age≤80 years, regardless of gender;
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Significant pain with a visual analog scale (VAS) score ≥ 4;
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Absence of other diseases causing skin temperature change;
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Participants can understand the study procedure and agree to sign the informed consent form.
Exclusion Criteria:
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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.
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Pregnant or lactating subjects;
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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;
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Participants with severe cognitive impairment who are unable to fully understand the trial protocol;
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Participants are taking part in other trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Third Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | China | 310000 |
| 2 | The Third Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
Investigators
- Principal Investigator: Hantong Hu, MD, The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Documents (Full-Text)
None provided.More Information
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.
- 2022ZB184