Affiliation:
1. Guang'anmen Hospital China Academy of Chinese Medicine Beijing China
2. The First Affiliated Hospital Henan University of Chinese Medicine Zhengzhou China
3. Department of Nursing Chongqing Traditional Chinese Medicine Hospital Chongqing China
4. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing China
5. T. H. Chan School of Public Health Harvard University Boston Massachusetts USA
6. Harvard Law School Harvard University Cambridge Massachusetts USA
7. John F. Kennedy School of Government Harvard University Cambridge Massachusetts USA
8. Department of Medicine School of Medicine Stanford University Stanford California USA
9. Department of Chinese Medicine The University of Hong Kong‐Shenzhen Hospital Shenzhen China
10. LKS Faculty of Medicine The University of Hong Kong Hong Kong Hong Kong
Abstract
AbstractBackgroundChronic back pain affected 619 million people globally in 2020 which accounts for a heavy disease burden causing tremendous productivity losses. Current therapies including ibuprofen, duloxetine, and opioids might cause side effects and even severe drug use disorders. Therefore, a non‐pharmacologic therapy with better or equivalent efficacy and fewer side effects is needed.MethodsWe did a multi‐center, single‐blinded, randomized, positive drug controlled, clinical trial. Patients with chronic back pain in moderate severity were randomized into receiving hot stone massage or flurbiprofen plaster group. Both interventions were 2 weeks with a follow‐up of 4 weeks. The primary outcome was the change in the score of the Global Pain Scale (GPS) from baseline to week 2. Secondary outcomes included Numerical Rating Scale (NRS), Chronic Pain Acceptance Questionnaire (CPAQ), Pain Self‐Efficacy Questionnaire (PSEQ), Hospital Anxiety and Depression Scale (HADS), and Short Form‐36 (SF36) from baseline to week 2 and week 6. Exploratory outcome assessment included the muscle thickness measured by ultrasound. Any adverse event was monitored throughout the study period.ResultsA total of 120 patients were enrolled in this trial. At 2 weeks GPS decreased significantly in the hot stone massage group compared to the flurbiprofen group (difference between groups = ‐8.1 points, 95% confidence interval [CI] ‐15.8 to ‐0.3, p = 0.047). Moreover, hot stone massage also showed more improvement at 2 weeks compared to flurbiprofen, including NRS (‐0.5 points, 95% CI ‐1.0 to ‐0.1, p = 0.029), PSEQ (5.4 points, 95% CI 0.5 to 10.2, p = 0.030), and mental component of Short Form‐36 (SF‐36) (1.7 points, 95% CI 0.4 to 2.9, p = 0.010), but not in CPAQ (p = 0.131), HADS (p = 0.303 for depression, p = 0.399 for anxiety), or SF‐36 (p = 0.129 for physical component, p = 0.246 for social component, p = 0.076 for fatigue component). A total of two participants in the hot stone massage group reported mild pain on skin surface when receiving the procedure at the first intervention session.