Daiki Kobayashi1, Takuro Shimbo2, Hana Hayashi3, Osamu Takahashi4. 1. Division of General Internal Medicine, Department of Medicine, St. Luke's International Hospital, Tokyo, Japan; Department of Epidemiology, St. Luke's International University Graduate School of Public Health, Tokyo, Japan; Fujita Health University, Toyoake, Japan. Electronic address: daikoba@luke.ac.jp. 2. Ohta Nishinouchi Hospital, Koriyama, Japan. 3. McCann Healthcare Worldwide Japan, Tokyo, Japan. 4. Division of General Internal Medicine, Department of Medicine, St. Luke's International Hospital, Tokyo, Japan; Department of Epidemiology, St. Luke's International University Graduate School of Public Health, Tokyo, Japan.
Abstract
BACKGROUND: Although Shiatsu, a kind of complementary alternative medicine, was developed in Japan and is practiced around the world, no experimental studies on Shiatsu have been conducted. The aim of this study is to investigate the efficacy of Shiatsu therapy for chronic lower back pain. METHOD: We conducted a prospective, randomized, open, blinded-endpoint design study at St. Luke's International Hospital, Tokyo, Japan from 2015 to 2017. Patients with lower back pain for more than 12 weeks and a score of four or more on theRoland-Morris Disability Questionnaire (RMDQ) at baseline were included in this study. We excluded patients with severe conditions, such as bone metastasis, or dementia. Patients were randomly allocated to either Shiatsu therapy in addition to standard care or standard care only by computer randomization. Those allocated to Shiatsu received one-hour Shiatsu every week for four weeks. Our primary outcome was improvement of RMDQ, and secondary outcomes were improvement of Short-Form McGill Pain Questionnaire (SF-MPQ), Oswestry Disability Index (ODI) and EQ-5D after 4 weeks and 8 weeks. Bivariate analyses were applied for assessing statistical significance. RESULT: Fifty-nine patients were included; 30 were allocated to Shiatsu, and 29 to the control group. None of the baseline characteristics were significantly different between groups. Twenty seven patients (90%) in the Shiatsu group and 24 patients (83%) in the control group completed the study. At week 4, Shiatsu group tended to show greater improvement only in EQ-5D (difference 0.068, p = 0.07), but not statistically significant, compared to control group, wheres other outcome measures were similar between the groups. At week 8, those in the Shiatsu group tended to have greater improvement in RMDQ (difference 1.7, p = 0.08) compared to the control group. The Shiatsu group showed greater improvement in present pain scale of SF-MPQ (difference 0.5, p < 0.05), ODI (difference 4.0, p < 0.01) and EQ-5D (difference 0.099, p = 0.01) compared to control group. CONCLUSION: In our limited sample trail, Shiatsu therapy combined with standard care for lower back pain improves some symptoms and QOL shortly after Shiatsu therapy.
RCT Entities:
BACKGROUND: Although Shiatsu, a kind of complementary alternative medicine, was developed in Japan and is practiced around the world, no experimental studies on Shiatsu have been conducted. The aim of this study is to investigate the efficacy of Shiatsu therapy for chronic lower back pain. METHOD: We conducted a prospective, randomized, open, blinded-endpoint design study at St. Luke's International Hospital, Tokyo, Japan from 2015 to 2017. Patients with lower back pain for more than 12 weeks and a score of four or more on the Roland-Morris Disability Questionnaire (RMDQ) at baseline were included in this study. We excluded patients with severe conditions, such as bone metastasis, or dementia. Patients were randomly allocated to either Shiatsu therapy in addition to standard care or standard care only by computer randomization. Those allocated to Shiatsu received one-hour Shiatsu every week for four weeks. Our primary outcome was improvement of RMDQ, and secondary outcomes were improvement of Short-Form McGill Pain Questionnaire (SF-MPQ), Oswestry Disability Index (ODI) and EQ-5D after 4 weeks and 8 weeks. Bivariate analyses were applied for assessing statistical significance. RESULT: Fifty-nine patients were included; 30 were allocated to Shiatsu, and 29 to the control group. None of the baseline characteristics were significantly different between groups. Twenty seven patients (90%) in the Shiatsu group and 24 patients (83%) in the control group completed the study. At week 4, Shiatsu group tended to show greater improvement only in EQ-5D (difference 0.068, p = 0.07), but not statistically significant, compared to control group, wheres other outcome measures were similar between the groups. At week 8, those in the Shiatsu group tended to have greater improvement in RMDQ (difference 1.7, p = 0.08) compared to the control group. The Shiatsu group showed greater improvement in present pain scale of SF-MPQ (difference 0.5, p < 0.05), ODI (difference 4.0, p < 0.01) and EQ-5D (difference 0.099, p = 0.01) compared to control group. CONCLUSION: In our limited sample trail, Shiatsu therapy combined with standard care for lower back pain improves some symptoms and QOL shortly after Shiatsu therapy.