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Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)

Primary Purpose

Herpes Zoster, Postherpetic Neuralgia, Pain

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sham-laser acupuncture
gabapentine
Acupuncture
Sponsored by
Dominik Irnich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring herpes zoster, neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Multidisciplinary Pain Unit, University of Munich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham-laser acupuncture

gabapentine

Acupuncture

Arm Description

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

standard analgesic treatment

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

Outcomes

Primary Outcome Measures

Alteration of pain intensity after treatment

Secondary Outcome Measures

Quantitative sensory testing

Full Information

First Posted
April 21, 2009
Last Updated
August 9, 2018
Sponsor
Dominik Irnich
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1. Study Identification

Unique Protocol Identification Number
NCT00885586
Brief Title
Acupuncture in Herpes Zoster Neuralgia (ACUZoster)
Acronym
ACUZoster
Official Title
Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
April 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominik Irnich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Postherpetic Neuralgia, Pain
Keywords
herpes zoster, neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham-laser acupuncture
Arm Type
Sham Comparator
Arm Description
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
Arm Title
gabapentine
Arm Type
Active Comparator
Arm Description
standard analgesic treatment
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Sham-laser acupuncture
Intervention Description
Laser irradiation is faked, approaching a non-functioning laser pen.
Intervention Type
Drug
Intervention Name(s)
gabapentine
Intervention Description
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
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
Primary Outcome Measure Information:
Title
Alteration of pain intensity after treatment
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Quantitative sensory testing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Multidisciplinary Pain Unit, University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19674449
Citation
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.
Results Reference
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Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

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