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Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial

BACKGROUND: Acute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objecti...

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Autores principales: Fleckenstein, Johannes, Kramer, Sybille, Hoffrogge, Philipp, Thoma, Sarah, Lang, Philip M, Lehmeyer, Lukas, Schober, Gabriel M, Pfab, Florian, Ring, Johannes, Weisenseel, Peter, Schotten, Klaus J, Mansmann, Ulrich, Irnich, Dominik
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2739152/
https://www.ncbi.nlm.nih.gov/pubmed/19674449
http://dx.doi.org/10.1186/1472-6882-9-31
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author Fleckenstein, Johannes
Kramer, Sybille
Hoffrogge, Philipp
Thoma, Sarah
Lang, Philip M
Lehmeyer, Lukas
Schober, Gabriel M
Pfab, Florian
Ring, Johannes
Weisenseel, Peter
Schotten, Klaus J
Mansmann, Ulrich
Irnich, Dominik
author_facet Fleckenstein, Johannes
Kramer, Sybille
Hoffrogge, Philipp
Thoma, Sarah
Lang, Philip M
Lehmeyer, Lukas
Schober, Gabriel M
Pfab, Florian
Ring, Johannes
Weisenseel, Peter
Schotten, Klaus J
Mansmann, Ulrich
Irnich, Dominik
author_sort Fleckenstein, Johannes
collection PubMed
description BACKGROUND: Acute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objective of the present study is to investigate whether a 4 week semi-standardised acupuncture is non-inferior to sham laser acupuncture and the anticonvulsive drug gabapentine in the treatment of pain associated with herpes zoster. METHODS/DESIGN: Three-armed, randomised, placebo-controlled trial with a total follow-up time of 6 months. Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900–3600 mg/d (84 patients); (c) sham laser acupuncture. Intervention takes place over 4 weeks, all patients will receive analgesic therapy (non-opioid analgesics: metamizol or paracetamol and opioids: tramadol or morphine). Therapy phase includes 4 weeks in which group (a) and (c) consist of 12 sessions per patient, (b) visits depend on patients needs. Main outcome measure is to assess the alteration of pain intensity before and 1 week after treatment sessions (visual analogue scale VAS 0–100 mm). Secondary outcome measure are: alteration of pain intensity and frequency of pain attacks; alteration of different aspects of pain evaluated by standardised pain questionnaires (NPI, PDI, SES); effects on quality of life (SF 36); analgesic demand; alteration of sensoric perception by systematic quantitative sensory testing (QST); incidence of postherpetic neuralgia; side effects and cost effectiveness. Credibility of treatments will be assessed. DISCUSSION: This study is the first large-scale randomised placebo controlled trial to evaluate the efficacy of acupuncture compared to gabapentine and sham treatment and will provide valuable new information about the clinical and physiological effects of acupuncture and gabapentine in the treatment of acute herpes zoster pain. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if acupuncture can be shown to be an effective treatment strategy in acute herpes zoster pain. TRIAL REGISTRATION: NCT00885586
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spelling pubmed-27391522009-09-08 Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial Fleckenstein, Johannes Kramer, Sybille Hoffrogge, Philipp Thoma, Sarah Lang, Philip M Lehmeyer, Lukas Schober, Gabriel M Pfab, Florian Ring, Johannes Weisenseel, Peter Schotten, Klaus J Mansmann, Ulrich Irnich, Dominik BMC Complement Altern Med Study Protocol BACKGROUND: Acute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objective of the present study is to investigate whether a 4 week semi-standardised acupuncture is non-inferior to sham laser acupuncture and the anticonvulsive drug gabapentine in the treatment of pain associated with herpes zoster. METHODS/DESIGN: Three-armed, randomised, placebo-controlled trial with a total follow-up time of 6 months. Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900–3600 mg/d (84 patients); (c) sham laser acupuncture. Intervention takes place over 4 weeks, all patients will receive analgesic therapy (non-opioid analgesics: metamizol or paracetamol and opioids: tramadol or morphine). Therapy phase includes 4 weeks in which group (a) and (c) consist of 12 sessions per patient, (b) visits depend on patients needs. Main outcome measure is to assess the alteration of pain intensity before and 1 week after treatment sessions (visual analogue scale VAS 0–100 mm). Secondary outcome measure are: alteration of pain intensity and frequency of pain attacks; alteration of different aspects of pain evaluated by standardised pain questionnaires (NPI, PDI, SES); effects on quality of life (SF 36); analgesic demand; alteration of sensoric perception by systematic quantitative sensory testing (QST); incidence of postherpetic neuralgia; side effects and cost effectiveness. Credibility of treatments will be assessed. DISCUSSION: This study is the first large-scale randomised placebo controlled trial to evaluate the efficacy of acupuncture compared to gabapentine and sham treatment and will provide valuable new information about the clinical and physiological effects of acupuncture and gabapentine in the treatment of acute herpes zoster pain. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if acupuncture can be shown to be an effective treatment strategy in acute herpes zoster pain. TRIAL REGISTRATION: NCT00885586 BioMed Central 2009-08-12 /pmc/articles/PMC2739152/ /pubmed/19674449 http://dx.doi.org/10.1186/1472-6882-9-31 Text en Copyright © 2009 Fleckenstein et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Fleckenstein, Johannes
Kramer, Sybille
Hoffrogge, Philipp
Thoma, Sarah
Lang, Philip M
Lehmeyer, Lukas
Schober, Gabriel M
Pfab, Florian
Ring, Johannes
Weisenseel, Peter
Schotten, Klaus J
Mansmann, Ulrich
Irnich, Dominik
Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title_full Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title_fullStr Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title_full_unstemmed Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title_short Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial
title_sort acupuncture in acute herpes zoster pain therapy (acuzoster) – design and protocol of a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2739152/
https://www.ncbi.nlm.nih.gov/pubmed/19674449
http://dx.doi.org/10.1186/1472-6882-9-31
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