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

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

doi:10.3389/fmed.2023.1215858

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

Front Med (Lausanne). 2023 Aug 16:10:1215858. doi: 10.3389/fmed.2023.1215858. eCollection 2023.

Authors

Li Li¹, Yawei Xi¹, Ying Wang¹, Yinqiu Gao¹, Xiaoying Lv², Shu Liu³, Guangjing Yang⁴, Jingjing Qian¹, Xiaofang Yang¹, Nardeen Ayad⁵, Jiayan Zhou⁶, Ya Xuan Sun⁷, Jin Liu⁸, Jinlin Li⁹, Guang Chen¹⁰

Affiliations

¹ Guang'anmen Hospital, China Academy of Chinese Medicine, Beijing, China.
² Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
³ The First Affiliated Hospital, Henan University of Chinese Medicine, Zhengzhou, Henan, China.
⁴ Chongqing Traditional Chinese Medicine Hospital, Chongqing, China.
⁵ Massachusetts General Hospital, Harvard Medical School, Harvard University, Boston, MA, United States.
⁶ Department of Medicine, Stanford University School of Medicine, Stanford, CA, United States.
⁷ Harvard T. H. Chan School of Public Health, Harvard University, Boston, MA, United States.
⁸ Johns Hopkins University School of Medicine, Baltimore, MD, United States.
⁹ John F. Kennedy School of Government, Harvard University, Cambridge, MA, United States.
¹⁰ Broad Institute of MIT and Harvard, Cambridge, MA, United States.

Abstract

Introduction: Chronic 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 analysis: This 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.

Discussion: The 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 registration: World 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].

Keywords: chronic pain; complementary medicine; massage; protocol; randomized clinical trial.