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Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stif...

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Autores principales: Xu, Jinhai, Zhou, Xiaoning, Xu, Chen, Xu, Chongqing, Ding, Xing, Jin, Kun, Yan, Ming, Ma, Junming, Wu, Xuequn, Ye, Jie, Mo, Wen, Yuan, Wen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478389/
https://www.ncbi.nlm.nih.gov/pubmed/32899045
http://dx.doi.org/10.1097/MD.0000000000021994
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author Xu, Jinhai
Zhou, Xiaoning
Xu, Chen
Xu, Chongqing
Ding, Xing
Jin, Kun
Yan, Ming
Ma, Junming
Wu, Xuequn
Ye, Jie
Mo, Wen
Yuan, Wen
author_facet Xu, Jinhai
Zhou, Xiaoning
Xu, Chen
Xu, Chongqing
Ding, Xing
Jin, Kun
Yan, Ming
Ma, Junming
Wu, Xuequn
Ye, Jie
Mo, Wen
Yuan, Wen
author_sort Xu, Jinhai
collection PubMed
description BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery. METHODS/DESIGN: A multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators. DISCUSSION: Although the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM. TRIAL REGISTRATION: Clinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019.
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spelling pubmed-74783892020-09-16 Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill Xu, Jinhai Zhou, Xiaoning Xu, Chen Xu, Chongqing Ding, Xing Jin, Kun Yan, Ming Ma, Junming Wu, Xuequn Ye, Jie Mo, Wen Yuan, Wen Medicine (Baltimore) 3700 BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery. METHODS/DESIGN: A multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators. DISCUSSION: Although the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM. TRIAL REGISTRATION: Clinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019. Lippincott Williams & Wilkins 2020-09-04 /pmc/articles/PMC7478389/ /pubmed/32899045 http://dx.doi.org/10.1097/MD.0000000000021994 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle 3700
Xu, Jinhai
Zhou, Xiaoning
Xu, Chen
Xu, Chongqing
Ding, Xing
Jin, Kun
Yan, Ming
Ma, Junming
Wu, Xuequn
Ye, Jie
Mo, Wen
Yuan, Wen
Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title_full Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title_fullStr Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title_full_unstemmed Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title_short Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill
title_sort clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by qishe pill
topic 3700
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478389/
https://www.ncbi.nlm.nih.gov/pubmed/32899045
http://dx.doi.org/10.1097/MD.0000000000021994
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