Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

NCT00885586 | Completed Phase 4 DMC

• 1 other identifier: AcuZoster Effectiveness 2006
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Herpes Zoster; Postherpetic Neuralgia; Pain

Keywords

herpes zoster; neuropathic pain; acupuncture; randomised controlled trial; acute herpes zoster

Outcome Measures

Primary Outcomes (1)

• Alteration of pain intensity after treatment

  5 weeks

Secondary Outcomes (1)

• Quantitative sensory testing

  6 months

Study Arms (3)

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

gabapentine

ACTIVE COMPARATOR

standard analgesic treatment

Drug: gabapentine

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

Interventions

Sham-laser acupuncture DEVICE

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

Sham-laser acupuncture

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

gabapentine

Acupuncture PROCEDURE

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

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of acute HZ
• Pain intensity \> 30 mm visual analog scale

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dominik Irnich: lead

Study Sites (1)

Multidisciplinary Pain Unit, University of Munich

Munich, Bavaria, 80336, Germany

Location

Related Publications (1)

• Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.

  PMID: 19674449 BACKGROUND

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic; Pain; Neuralgia

Interventions

Gabapentin; Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. Dominik Irnich

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: November 1, 2008
• Primary Completion: August 29, 2017
• Study Completion: April 5, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

DE (1)