Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial

IntroductionChronic musculoskeletal pain bothers the quality of life for approximately 1.71 billion people worldwide. Although pharmacological therapies play an important role in controlling chronic pain, overuse of opioids, persistent or recurrent symptoms, and pain-related disability burden still...

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Main Authors: Li Li, Yawei Xi, Ying Wang, Yinqiu Gao, Xiaoying Lv, Shu Liu, Guangjing Yang, Jingjing Qian, Xiaofang Yang, Nardeen Ayad, Jiayan Zhou, Ya Xuan Sun, Jin Liu, Jinlin Li, Guang Chen
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-08-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1215858/full
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author Li Li
Yawei Xi
Ying Wang
Yinqiu Gao
Xiaoying Lv
Shu Liu
Guangjing Yang
Jingjing Qian
Xiaofang Yang
Nardeen Ayad
Jiayan Zhou
Ya Xuan Sun
Jin Liu
Jinlin Li
Guang Chen
author_facet Li Li
Yawei Xi
Ying Wang
Yinqiu Gao
Xiaoying Lv
Shu Liu
Guangjing Yang
Jingjing Qian
Xiaofang Yang
Nardeen Ayad
Jiayan Zhou
Ya Xuan Sun
Jin Liu
Jinlin Li
Guang Chen
author_sort Li Li
collection DOAJ
description IntroductionChronic musculoskeletal pain bothers the quality of life for approximately 1.71 billion people worldwide. Although pharmacological therapies play an important role in controlling chronic pain, overuse of opioids, persistent or recurrent symptoms, and pain-related disability burden still need to be addressed. Heat-stone massage is using the heated stone to stimulate muscles and ligaments followed by massage for relax, which can potentially treat the chronic musculoskeletal pain. To determine the efficacy and safety of heat-stone massage for patients with chronic musculoskeletal pain is needed.Methods and analysisThis multicenter, 2-arm, randomized, positive drug-controlled trial will include a total of 120 patients with chronic musculoskeletal pain. The intervention group will receive a 2 week heat-stone massage, 3 times per week, whereas the control group will receive the flurbiprofen plaster twice per day for 2 weeks. The primary end point is the change in Global Pain Scale from baseline to the end of the 2 week intervention. The secondary outcomes include the pain severity (Numerical Rating Scale), pain acceptance (Chronic Pain Acceptance Questionnaire), self-management (Health Education Impact Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (Short Form-36). The intention-to-treat dataset will be used for analysis.DiscussionThe pain management remains the research topic that patients always pay close attention to. This will be the first randomized clinical trial to evaluate whether heat-stone massage, a non-pharmacological therapy, is effective in the chronic musculoskeletal pain management. The results will provide evidence for new option of daily practice.Clinical trial registrationWorld Health Organization Chinese Clinical Trial Registry [ChiCTR2200065654; https://www.chictr.org.cn/showproj.html?proj=185403]; International Traditional Medicine Clinical Trial Registry [ITMCTR2022000104; http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=51776b6f-77b8-4811-9b5a-a0fec10f2cee].
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spelling doaj.art-80d6ba8f375241918cd18de19aed92492023-08-17T10:33:19ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-08-011010.3389/fmed.2023.12158581215858Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trialLi Li0Yawei Xi1Ying Wang2Yinqiu Gao3Xiaoying Lv4Shu Liu5Guangjing Yang6Jingjing Qian7Xiaofang Yang8Nardeen Ayad9Jiayan Zhou10Ya Xuan Sun11Jin Liu12Jinlin Li13Guang Chen14Guang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, ChinaThe First Affiliated Hospital, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaChongqing Traditional Chinese Medicine Hospital, Chongqing, ChinaGuang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medicine, Beijing, ChinaMassachusetts General Hospital, Harvard Medical School, Harvard University, Boston, MA, United StatesDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, United StatesHarvard T. H. Chan School of Public Health, Harvard University, Boston, MA, United StatesJohns Hopkins University School of Medicine, Baltimore, MD, United StatesJohn F. Kennedy School of Government, Harvard University, Cambridge, MA, United States0Broad Institute of MIT and Harvard, Cambridge, MA, United StatesIntroductionChronic musculoskeletal pain bothers the quality of life for approximately 1.71 billion people worldwide. Although pharmacological therapies play an important role in controlling chronic pain, overuse of opioids, persistent or recurrent symptoms, and pain-related disability burden still need to be addressed. Heat-stone massage is using the heated stone to stimulate muscles and ligaments followed by massage for relax, which can potentially treat the chronic musculoskeletal pain. To determine the efficacy and safety of heat-stone massage for patients with chronic musculoskeletal pain is needed.Methods and analysisThis multicenter, 2-arm, randomized, positive drug-controlled trial will include a total of 120 patients with chronic musculoskeletal pain. The intervention group will receive a 2 week heat-stone massage, 3 times per week, whereas the control group will receive the flurbiprofen plaster twice per day for 2 weeks. The primary end point is the change in Global Pain Scale from baseline to the end of the 2 week intervention. The secondary outcomes include the pain severity (Numerical Rating Scale), pain acceptance (Chronic Pain Acceptance Questionnaire), self-management (Health Education Impact Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (Short Form-36). The intention-to-treat dataset will be used for analysis.DiscussionThe pain management remains the research topic that patients always pay close attention to. This will be the first randomized clinical trial to evaluate whether heat-stone massage, a non-pharmacological therapy, is effective in the chronic musculoskeletal pain management. The results will provide evidence for new option of daily practice.Clinical trial registrationWorld Health Organization Chinese Clinical Trial Registry [ChiCTR2200065654; https://www.chictr.org.cn/showproj.html?proj=185403]; International Traditional Medicine Clinical Trial Registry [ITMCTR2022000104; http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=51776b6f-77b8-4811-9b5a-a0fec10f2cee].https://www.frontiersin.org/articles/10.3389/fmed.2023.1215858/fullmassagecomplementary medicinechronic painrandomized clinical trialprotocol
spellingShingle Li Li
Yawei Xi
Ying Wang
Yinqiu Gao
Xiaoying Lv
Shu Liu
Guangjing Yang
Jingjing Qian
Xiaofang Yang
Nardeen Ayad
Jiayan Zhou
Ya Xuan Sun
Jin Liu
Jinlin Li
Guang Chen
Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
Frontiers in Medicine
massage
complementary medicine
chronic pain
randomized clinical trial
protocol
title Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
title_full Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
title_fullStr Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
title_full_unstemmed Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
title_short Heat-stone massage for patients with chronic musculoskeletal pain: a protocol for multicenter randomized controlled trial
title_sort heat stone massage for patients with chronic musculoskeletal pain a protocol for multicenter randomized controlled trial
topic massage
complementary medicine
chronic pain
randomized clinical trial
protocol
url https://www.frontiersin.org/articles/10.3389/fmed.2023.1215858/full
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