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Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)

This study is currently recruiting participants.
Verified February 2017 by Dominik Irnich, Ludwig-Maximilians - University of Munich
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885586
First Posted: April 22, 2009
Last Update Posted: February 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dominik Irnich, Ludwig-Maximilians - University of Munich
  Purpose

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 Intervention Phase
Herpes Zoster Postherpetic Neuralgia Pain Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Shingles
U.S. FDA Resources

Further study details as provided by Dominik Irnich, Ludwig-Maximilians - University of Munich:

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

Secondary Outcome Measures:
  • Quantitative sensory testing [ Time Frame: 6 months ]
Estimated Enrollment: 336
Study Start Date: November 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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
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 ClinicalTrials.gov identifier (NCT number): NCT00885586


Contacts
Contact: Dominik F Irnich, MD, PhD +495160 ext 7508 dominik.irnich@med.uni-muenchen.de

Locations
Germany
Multidisciplinary Pain Unit, University of Munich Recruiting
Munich, Bavaria, Germany, 80336
Contact: Petra Bäumler, MSc    +49894400 ext 57508    petra.baeumler@med.uni-muenchen.de   
Sub-Investigator: Johannes Fleckenstein, MD         
Sponsors and Collaborators
Dominik Irnich
  More Information

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 Submitted: April 21, 2009
First Posted: April 22, 2009
Last Update Posted: February 6, 2017
Last Verified: February 2017

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, Postherpetic
Neuralgia
Herpes Zoster
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