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Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885586
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Dominik Irnich, Ludwig-Maximilians - University of Munich

Brief Summary:

Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life.

The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires

Condition or disease Intervention/treatment Phase
Herpes Zoster Postherpetic Neuralgia Pain Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
Study Start Date : November 2008
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Shingles
Drug Information available for: Gabapentin

Arm Intervention/treatment
Sham Comparator: Sham-laser acupuncture
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
Device: Sham-laser acupuncture
Laser irradiation is faked, approaching a non-functioning laser pen.

Active Comparator: gabapentine
standard analgesic treatment
Drug: gabapentine
Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer

Active Comparator: Acupuncture
Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern.
Procedure: Acupuncture
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.

Primary Outcome Measures :
  1. Alteration of pain intensity after treatment [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Quantitative sensory testing [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of acute HZ
  • Pain intensity > 30 mm visual analog scale

Exclusion Criteria:

  • Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
  • Patients under age
  • Uncompliance
  • Pregnancy or lactation
  • Surgery within the last 3 month
  • Severe heart/lung/kidney disease
  • Diseases influencing the quality of life
  • Psychiatric diseases (e.g., depression, schizophrenia, dementia)
  • Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
  • Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
  • Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885586

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Multidisciplinary Pain Unit, University of Munich
Munich, Bavaria, Germany, 80336
Sponsors and Collaborators
Dominik Irnich

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Responsible Party: Dominik Irnich, PD Dr. Dominik Irnich, Ludwig-Maximilians - University of Munich Identifier: NCT00885586     History of Changes
Other Study ID Numbers: AcuZoster Effectiveness 2006
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Dominik Irnich, Ludwig-Maximilians - University of Munich:
herpes zoster
neuropathic pain
randomised controlled trial
acute herpes zoster
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents