Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Dominik Irnich

Status and phase: Completed; Phase 4

Conditions: Postherpetic Neuralgia; Herpes Zoster; Pain

Treatments: Procedure: Acupuncture; Device: Sham-laser acupuncture; Drug: gabapentine

Study type: Interventional

Funder types: Other

Identifiers

NCT00885586

AcuZoster Effectiveness 2006

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 3 patient groups

Sham-laser acupuncture

Sham Comparator group

Description:

Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.

Treatment:

Device: Sham-laser acupuncture

gabapentine

Active Comparator group

Description:

standard analgesic treatment

Treatment:

Drug: gabapentine

Acupuncture

Active Comparator group

Description:

Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern.

Treatment:

Procedure: Acupuncture