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Completed

NCT Number: NCT00885586

Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

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

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postherpetic Neuralgia Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Multidisciplinary Pain Unit, University of Munich

Munich, Bavaria, 80336, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sham-laser acupuncture

Device

Laser irradiation is faked, approaching a non-functioning laser pen.

Gabapentine

Drug

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

Procedure

The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.

Primary outcomes

  1. Alteration of pain intensity after treatment

    Time frame: 5 weeks

Secondary outcomes

  1. Quantitative sensory testing

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Dominik Irnich

Other

Registry information

Official study title

Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia

Acronym: ACUZoster

Important dates

Study start
2008
Primary completion
2017
Study completion
2018
First posted
Apr 22, 2009
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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