Cargando…

Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial

BACKGROUND: Lumbar disc herniation is a major cause of sciatica and low back pain and imposes a heavy burden on both individual and society. While use of pharmacopuncture, a combined form of acupuncture and herbal medicine, for lumbar disc herniation is widespread in Korea and China, there is a pauc...

Descripción completa

Detalles Bibliográficos
Autores principales: Lee, Jinho, Shin, Joon-Shik, Lee, Yoon Jae, Kim, Me-riong, Ahn, Yong-jun, Park, Ki Byung, Kropf, Michael A., Shin, Byung-Cheul, Lee, Myeong Soo, Ha, In-Hyuk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603920/
https://www.ncbi.nlm.nih.gov/pubmed/26459006
http://dx.doi.org/10.1186/s13063-015-0993-6
_version_ 1782394981521031168
author Lee, Jinho
Shin, Joon-Shik
Lee, Yoon Jae
Kim, Me-riong
Ahn, Yong-jun
Park, Ki Byung
Kropf, Michael A.
Shin, Byung-Cheul
Lee, Myeong Soo
Ha, In-Hyuk
author_facet Lee, Jinho
Shin, Joon-Shik
Lee, Yoon Jae
Kim, Me-riong
Ahn, Yong-jun
Park, Ki Byung
Kropf, Michael A.
Shin, Byung-Cheul
Lee, Myeong Soo
Ha, In-Hyuk
author_sort Lee, Jinho
collection PubMed
description BACKGROUND: Lumbar disc herniation is a major cause of sciatica and low back pain and imposes a heavy burden on both individual and society. While use of pharmacopuncture, a combined form of acupuncture and herbal medicine, for lumbar disc herniation is widespread in Korea and China, there is a paucity of research. METHODS/DESIGN: This study is the protocol for a three-armed, randomized, patient, physician, and assessor-blinded controlled pilot study. Sixty patients with severe non-acute sciatic pain diagnosed with lumbar disc herniation (NRS ≥ 5, onset between 4 weeks and 6 months) will be recruited and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture with acupuncture), acupuncture, and usual care groups, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2–3 times/day and physical therapy 2 sessions/week over 4 weeks (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group during acupuncture needle retention. The second physician will administer acupuncture and pharmacopuncture in a similar manner in terms of advice and manual stimulation to maintain patient-blinding, treat the patient out of view of the initial physician, remove the additional acupuncture needle immediately, and cover the area with adhesive bandage to maintain physician-blinding. The primary endpoint will be at 5 weeks post-randomization, and the primary outcome will be Visual Analog Scale (VAS) of sciatic pain. Secondary outcomes will be VAS of low back pain, Numeric Rating Scale (NRS) of low back pain and sciatic pain, ODI, SF-36, EQ-5D, and PGIC. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization. DISCUSSION: This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation with usual care of conventional medicine and that of Korean medicine (acupuncture), monitor its safety, and serve as basis for a large-scale, multicenter trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02384928, registered 27 February 2015.
format Online
Article
Text
id pubmed-4603920
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-46039202015-10-14 Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial Lee, Jinho Shin, Joon-Shik Lee, Yoon Jae Kim, Me-riong Ahn, Yong-jun Park, Ki Byung Kropf, Michael A. Shin, Byung-Cheul Lee, Myeong Soo Ha, In-Hyuk Trials Study Protocol BACKGROUND: Lumbar disc herniation is a major cause of sciatica and low back pain and imposes a heavy burden on both individual and society. While use of pharmacopuncture, a combined form of acupuncture and herbal medicine, for lumbar disc herniation is widespread in Korea and China, there is a paucity of research. METHODS/DESIGN: This study is the protocol for a three-armed, randomized, patient, physician, and assessor-blinded controlled pilot study. Sixty patients with severe non-acute sciatic pain diagnosed with lumbar disc herniation (NRS ≥ 5, onset between 4 weeks and 6 months) will be recruited and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture with acupuncture), acupuncture, and usual care groups, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2–3 times/day and physical therapy 2 sessions/week over 4 weeks (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group during acupuncture needle retention. The second physician will administer acupuncture and pharmacopuncture in a similar manner in terms of advice and manual stimulation to maintain patient-blinding, treat the patient out of view of the initial physician, remove the additional acupuncture needle immediately, and cover the area with adhesive bandage to maintain physician-blinding. The primary endpoint will be at 5 weeks post-randomization, and the primary outcome will be Visual Analog Scale (VAS) of sciatic pain. Secondary outcomes will be VAS of low back pain, Numeric Rating Scale (NRS) of low back pain and sciatic pain, ODI, SF-36, EQ-5D, and PGIC. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization. DISCUSSION: This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation with usual care of conventional medicine and that of Korean medicine (acupuncture), monitor its safety, and serve as basis for a large-scale, multicenter trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02384928, registered 27 February 2015. BioMed Central 2015-10-12 /pmc/articles/PMC4603920/ /pubmed/26459006 http://dx.doi.org/10.1186/s13063-015-0993-6 Text en © Lee et al. 2015 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
Lee, Jinho
Shin, Joon-Shik
Lee, Yoon Jae
Kim, Me-riong
Ahn, Yong-jun
Park, Ki Byung
Kropf, Michael A.
Shin, Byung-Cheul
Lee, Myeong Soo
Ha, In-Hyuk
Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title_full Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title_fullStr Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title_full_unstemmed Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title_short Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
title_sort effects of shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603920/
https://www.ncbi.nlm.nih.gov/pubmed/26459006
http://dx.doi.org/10.1186/s13063-015-0993-6
work_keys_str_mv AT leejinho effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT shinjoonshik effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT leeyoonjae effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT kimmeriong effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT ahnyongjun effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT parkkibyung effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT kropfmichaela effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT shinbyungcheul effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT leemyeongsoo effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial
AT hainhyuk effectsofshinbaropharmacopunctureinsciaticpainpatientswithlumbardischerniationstudyprotocolforarandomizedcontrolledtrial