Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Multidisciplinary Pain Unit, University of Munich
Munich, Bavaria, Germany, 80336

Sponsors and Collaborators

Dominik Irnich

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

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
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