Cargando…

Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial

BACKGROUND: Sciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment opt...

Descripción completa

Detalles Bibliográficos
Autores principales: Kim, Koh-Woon, Park, Kyungmo, Park, Hi-Joon, Jahng, Geon-Ho, Jo, Dae-Jean, Cho, Jae-Heung, Song, Eun-Mo, Shin, Woo-Chul, Yoon, Ye-Ji, Kim, Soo-Jeon, Eun, Seulgi, Song, Mi-Yeon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6335765/
https://www.ncbi.nlm.nih.gov/pubmed/30651139
http://dx.doi.org/10.1186/s13063-018-3164-8
_version_ 1783387952600055808
author Kim, Koh-Woon
Park, Kyungmo
Park, Hi-Joon
Jahng, Geon-Ho
Jo, Dae-Jean
Cho, Jae-Heung
Song, Eun-Mo
Shin, Woo-Chul
Yoon, Ye-Ji
Kim, Soo-Jeon
Eun, Seulgi
Song, Mi-Yeon
author_facet Kim, Koh-Woon
Park, Kyungmo
Park, Hi-Joon
Jahng, Geon-Ho
Jo, Dae-Jean
Cho, Jae-Heung
Song, Eun-Mo
Shin, Woo-Chul
Yoon, Ye-Ji
Kim, Soo-Jeon
Eun, Seulgi
Song, Mi-Yeon
author_sort Kim, Koh-Woon
collection PubMed
description BACKGROUND: Sciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment options for sciatica, acupuncture is a possible option; however, evidence supporting its efficacy and mechanism in patients with sciatica is lacking. The aim of this proposed protocol is to investigate the effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica. METHODS/DESIGN: This study is a randomized, patient-assessor blind, two-arm, parallel, non-penetrating, sham-controlled clinical trial. Eligible participants will include adults (aged 19–70 years old) with a clinical diagnosis of chronic sciatica (40 mm or more of a 100-mm visual analog scale (VAS) for bothersomeness) blinded to the treatment received. Patients will be randomly allocated into the acupuncture treatment group (manual acupuncture plus electroacupuncture (EA), n = 34) or the sham acupuncture control group (sham acupuncture plus placebo EA without electrical stimulation, n = 34). Groups will receive treatment twice a week for a total of eight sessions over 4 weeks. Functional magnetic resonance imaging will be implemented at baseline and endpoint to investigate the mechanism of acupuncture. The primary outcome measure is the VAS for bothersomeness and secondary outcomes include the VAS for pain intensity, Oswestry Disability Index, EuroQol 5-Dimension, Coping Strategy Questionnaire, Beck’s Depression Inventory, and State-Trait Anxiety Inventory. Adverse events will be assessed at every visit. DISCUSSION: The results of this trial (which will be available in 2020) should provide important clinical evidence for the effect of acupuncture and demonstrate how acupuncture can be helpful for the treatment of chronic sciatica. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03350789. Registered on 15 November 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-3164-8) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-6335765
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-63357652019-01-23 Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial Kim, Koh-Woon Park, Kyungmo Park, Hi-Joon Jahng, Geon-Ho Jo, Dae-Jean Cho, Jae-Heung Song, Eun-Mo Shin, Woo-Chul Yoon, Ye-Ji Kim, Soo-Jeon Eun, Seulgi Song, Mi-Yeon Trials Study Protocol BACKGROUND: Sciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment options for sciatica, acupuncture is a possible option; however, evidence supporting its efficacy and mechanism in patients with sciatica is lacking. The aim of this proposed protocol is to investigate the effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica. METHODS/DESIGN: This study is a randomized, patient-assessor blind, two-arm, parallel, non-penetrating, sham-controlled clinical trial. Eligible participants will include adults (aged 19–70 years old) with a clinical diagnosis of chronic sciatica (40 mm or more of a 100-mm visual analog scale (VAS) for bothersomeness) blinded to the treatment received. Patients will be randomly allocated into the acupuncture treatment group (manual acupuncture plus electroacupuncture (EA), n = 34) or the sham acupuncture control group (sham acupuncture plus placebo EA without electrical stimulation, n = 34). Groups will receive treatment twice a week for a total of eight sessions over 4 weeks. Functional magnetic resonance imaging will be implemented at baseline and endpoint to investigate the mechanism of acupuncture. The primary outcome measure is the VAS for bothersomeness and secondary outcomes include the VAS for pain intensity, Oswestry Disability Index, EuroQol 5-Dimension, Coping Strategy Questionnaire, Beck’s Depression Inventory, and State-Trait Anxiety Inventory. Adverse events will be assessed at every visit. DISCUSSION: The results of this trial (which will be available in 2020) should provide important clinical evidence for the effect of acupuncture and demonstrate how acupuncture can be helpful for the treatment of chronic sciatica. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03350789. Registered on 15 November 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-3164-8) contains supplementary material, which is available to authorized users. BioMed Central 2019-01-16 /pmc/articles/PMC6335765/ /pubmed/30651139 http://dx.doi.org/10.1186/s13063-018-3164-8 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kim, Koh-Woon
Park, Kyungmo
Park, Hi-Joon
Jahng, Geon-Ho
Jo, Dae-Jean
Cho, Jae-Heung
Song, Eun-Mo
Shin, Woo-Chul
Yoon, Ye-Ji
Kim, Soo-Jeon
Eun, Seulgi
Song, Mi-Yeon
Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title_full Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title_fullStr Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title_full_unstemmed Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title_short Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
title_sort effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6335765/
https://www.ncbi.nlm.nih.gov/pubmed/30651139
http://dx.doi.org/10.1186/s13063-018-3164-8
work_keys_str_mv AT kimkohwoon effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT parkkyungmo effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT parkhijoon effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT jahnggeonho effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT jodaejean effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT chojaeheung effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT songeunmo effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT shinwoochul effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT yoonyeji effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT kimsoojeon effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT eunseulgi effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial
AT songmiyeon effectandneurophysiologicalmechanismofacupunctureinpatientswithchronicsciaticaprotocolforarandomizedpatientassessorblindshamcontrolledclinicaltrial