| Summary: | Background Appropriate and effective prevention and treatment of knee osteoarthritis (KOA) has become a challenge faced by medical institutions. Clinical evidence shows that both the royal TCM-based tendon-regulation manipulation and joint mobilization are effective for KOA, but there are few comparative studies of them in KOA. Objective To compare the similarities and differences between the royal TCM-based tendon-regulation manipulation and joint mobilization in the treatment of KOA, promoting the normalization and standardization of manipulative medicine worldwide. Methods From October 2020 to June 2021, 67 KOA patients who met the requirements were recruited from the Massage Department of Dongzhimen Hospital, Beijing University of Chinese Medicine. They were randomly divided into royal TCM-based tendon-regulation manipulation (n=33) and joint mobilization (n=34) . The two groups of patients received 10 treatments for 4 weeks, 4 cases fell off midway, and 63 patients were finally included. A mixed method of quantitative and qualitative analysis was adopted. Quantitative data collected were pre- and post-treatment assessment of the clinical responses in two groups with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . Qualitative data were collected using semi-structured individual interviews conducted in the participants based on topics of the efficacies and assessment of the two treatments for KOA, and understanding of the massage therapy. The similarities and differences between the two treatments were compared, and analyzed using thematic analysis. Parallel comparison and joint display were used for integrative analysis of the mixed data. Results Efficacy evaluation: there was no statistically significant difference in the total score of WOMAC between the two groups after 4 weeks of treatment (P>0.05) , the total scores of WOMAC in both groups were lower than those before treatment (P<0.05) . According to the interview, there were no significant differences in patient-assessed efficacies (positive, neutral or negative evaluation) between the two treatments. Besides that, patients' positive, neutral and negative perceptions of massage were basically the same before and after treatment, but after treatment, patients' perception of massage inclined to be positive. The results of quantitative analysis showed that the curative effect was not related to previous hospital treatment with massage therapy. The efficacy was also not related to the success of blinding. There was no significant correlation between the success of blinding and the type of treatment or previous massage treatment. Patients' perceptions of massage were not associated with the efficacy, and the type of treatment received by them. Manipulation evaluation: There were no significant differences in the two treatments assessed by patients in terms of strength, pain degree, manipulation characteristics, onset time of curative effect and number of times with the most obvious perceived curative effect after the first or fourth week of treatment. Conclusion Quantitative and qualitative studies show that both the royal TCM-based tendon-regulation manipulation and joint mobilization are safe and effective for KOA, and they have no significant differences in patient-assessed efficacy and manipulation skills, as well as patients' perceptions of them.
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