Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Ludwig-Maximilians - University of Munich
Sponsor:
Dominik Irnich
Information provided by (Responsible Party):
Dominik Irnich, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00885586
First received: April 21, 2009
Last updated: September 7, 2016
Last verified: September 2016
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Postherpetic Neuralgia Pain |
Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia |
Resource links provided by NLM:
Further study details as provided by Ludwig-Maximilians - University of Munich:
Primary Outcome Measures:
- Alteration of pain intensity after treatment [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quantitative sensory testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 336 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: Sham-laser acupuncture
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
|
Device: Sham-laser acupuncture
Laser irradiation is faked, approaching a non-functioning laser pen.
|
|
Active Comparator: gabapentine
standard analgesic treatment
|
Drug: 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
|
|
Active Comparator: 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.
|
Procedure: Acupuncture
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885586
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885586
Contacts
| Contact: Dominik F Irnich, MD, PhD | +495160 ext 7508 | dominik.irnich@med.uni-muenchen.de |
Locations
| Germany | |
| Multidisciplinary Pain Unit, University of Munich | Recruiting |
| Munich, Bavaria, Germany, 80336 | |
| Contact: Petra Bäumler, MSc +49894400 ext 57508 petra.baeumler@med.uni-muenchen.de | |
| Sub-Investigator: Johannes Fleckenstein, MD | |
Sponsors and Collaborators
Dominik Irnich
More Information
Publications:
| Responsible Party: | Dominik Irnich, PD Dr. Dominik Irnich, Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT00885586 History of Changes |
| Other Study ID Numbers: | AcuZoster Effectiveness 2006 |
| Study First Received: | April 21, 2009 |
| Last Updated: | September 7, 2016 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ludwig-Maximilians - University of Munich:
|
herpes zoster neuropathic pain acupuncture randomised controlled trial acute herpes zoster |
Additional relevant MeSH terms:
|
Neuralgia, Postherpetic Neuralgia Herpes Zoster Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on September 23, 2016