Acupuncture in Herpes Zoster Neuralgia (ACUZoster) - Full Text View

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00885586

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 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 Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham-laser acupuncture: Sham Comparator 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.
gabapentine: Active Comparator 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
Acupuncture: Active Comparator 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

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 Centre, Department of AnaesthesiologyUniversity of Munich	Recruiting
Munich, Germany
Contact: Dominik F Irnich, MD, PhD +495160 ext 7508 dominik.irnich@med.uni-muenchen.de
Principal Investigator: Dominik Irnich, MD, PhD

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

More Information

No publications provided

Responsible Party:	Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany ( PD Dr. Dominik Irnich, MD, PhD )
Study ID Numbers:	AcuZoster Effectiveness 2006
Study First Received:	April 21, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00885586 History of Changes
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

Study placed in the following topic categories:

Virus Diseases
Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Neurologic Manifestations
DNA Virus Infections
Pain
Analgesics
Herpesviridae Infections

Additional relevant MeSH terms:

Virus Diseases
Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on August 24, 2009