Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Phase 4

Completed

• Conditions: Postherpetic Neuralgia; Pain; Herpes Zoster
• Interventions: Device: Sham-laser acupuncture; Procedure: Acupuncture; Drug: gabapentine

• Registration Number: NCT00885586
• Lead Sponsor: Dominik Irnich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2017-08-29
• Study Completion: 2018-04-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-laser acupuncture	Sham-laser acupuncture	Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
Acupuncture	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.
gabapentine	gabapentine	standard analgesic treatment

Primary Outcome Measures

Name	Time	Method
Alteration of pain intensity after treatment	5 weeks

Secondary Outcome Measures

Name	Time	Method
Quantitative sensory testing	6 months

Trial Locations

Locations (1)

Multidisciplinary Pain Unit, University of Munich; 🇩🇪 Munich, Bavaria, Germany