Acupuncture in Herpes Zoster Neuralgia (ACUZoster) (ACUZoster)
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
|Herpes Zoster Postherpetic Neuralgia Pain||Device: Sham-laser acupuncture Drug: gabapentine Procedure: Acupuncture||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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|
- Alteration of pain intensity after treatment [ Time Frame: 5 weeks ]
- Quantitative sensory testing [ Time Frame: 6 months ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885586
|Contact: Dominik F Irnich, MD, PhD||+495160 ext firstname.lastname@example.org|
|Multidisciplinary Pain Unit, University of Munich||Recruiting|
|Munich, Bavaria, Germany, 80336|
|Contact: Petra Bäumler, MSc +49894400 ext 57508 email@example.com|
|Sub-Investigator: Johannes Fleckenstein, MD|