Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Dominik Irnich, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00885586
First received: April 21, 2009
Last updated: March 8, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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

Primary Outcome Measures:
  • Alteration of pain intensity after treatment [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative sensory testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 336
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Johannes Fleckenstein, MD    +49895160 ext 7508    johannes.fleckenstein@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
Study First Received: April 21, 2009
Last Updated: March 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
herpes zoster
neuropathic pain
acupuncture
randomised controlled trial
acute herpes zoster

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Herpes Zoster
Neuralgia
DNA Virus Infections
Herpesviridae Infections
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014