Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)
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|ClinicalTrials.gov Identifier: NCT00885586|
Recruitment Status : Recruiting
First Posted : April 22, 2009
Last Update Posted : February 6, 2017
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 or disease||Intervention/treatment||Phase|
|Herpes Zoster Postherpetic Neuralgia Pain||Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
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
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.
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
- Alteration of pain intensity after treatment [ Time Frame: 5 weeks ]
- Quantitative sensory testing [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885586
|Contact: Dominik F Irnich, MD, PhD||+495160 ext email@example.com|
|Multidisciplinary Pain Unit, University of Munich||Recruiting|
|Munich, Bavaria, Germany, 80336|
|Contact: Petra Bäumler, MSc +49894400 ext 57508 firstname.lastname@example.org|
|Sub-Investigator: Johannes Fleckenstein, MD|