Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)
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ClinicalTrials.gov Identifier: NCT00885586 |
Recruitment Status
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Active, not recruiting
First Posted
: April 22, 2009
Last Update Posted
: March 20, 2018
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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 |
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Herpes Zoster Postherpetic Neuralgia Pain | Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture | Phase 4 |
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 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
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Sham Comparator: Sham-laser acupuncture
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
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Device: Sham-laser acupuncture
Laser irradiation is faked, approaching a non-functioning laser pen.
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Active Comparator: gabapentine
standard analgesic treatment
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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
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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.
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Procedure: Acupuncture
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
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- Alteration of pain intensity after treatment [ Time Frame: 5 weeks ]
- Quantitative sensory testing [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00885586
Germany | |
Multidisciplinary Pain Unit, University of Munich | |
Munich, Bavaria, Germany, 80336 |
Publications:
Responsible Party: | Dominik Irnich, PD Dr. Dominik Irnich, Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00885586 History of Changes |
Other Study ID Numbers: |
AcuZoster Effectiveness 2006 |
First Posted: | April 22, 2009 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
Keywords provided by Dominik Irnich, Ludwig-Maximilians - University of Munich:
herpes zoster neuropathic pain acupuncture randomised controlled trial acute herpes zoster |
Additional relevant MeSH terms:
Neuralgia Herpes Zoster Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Herpesviridae Infections DNA Virus Infections Virus Diseases Gabapentin gamma-Aminobutyric Acid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |