Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Dominik Irnich68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Herpes Zoster Postherpetic Neuralgia Pain

Interventions

Sham-laser acupunctureDEVICE

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

gabapentineDRUG

Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer

AcupuncturePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes