Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

NCT ID: NCT00885586

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2018-04-05

Brief Summary

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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

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Conditions

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Herpes Zoster Postherpetic Neuralgia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham-laser acupuncture

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

Group Type SHAM_COMPARATOR

Sham-laser acupuncture

Intervention Type DEVICE

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

gabapentine

standard analgesic treatment

Group Type ACTIVE_COMPARATOR

gabapentine

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

Interventions

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Sham-laser acupuncture

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

Intervention Type DEVICE

gabapentine

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

Intervention Type DRUG

Acupuncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dominik Irnich

OTHER

Sponsor Role lead

Responsible Party

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Dominik Irnich

PD Dr. Dominik Irnich

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Multidisciplinary Pain Unit, University of Munich

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19674449 (View on PubMed)

Other Identifiers

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AcuZoster Effectiveness 2006

Identifier Type: -

Identifier Source: org_study_id

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