Acupuncture has increasingly gained popularity as alternative approach to conventional care for knee osteoarthritis (KOA) management. We conducted a pragmatic randomized controlled study to evaluate the clinical and health utility outcomes of acupuncture and heat therapy in conjunction with standard care for KOA. Community-ambulating KOA patients of 45 years or older were randomly assigned to the intervention or control (SC) group. The HARMOKnee group received 12 acupuncture and heat treatments in addition to standard care for six weeks. We evaluated the Knee Injury and Osteoarthritis and Outcome Score-12 (KOOS-12) at baseline, 6-, 12- and 24-week. Secondary outcomes including Pain, Enjoyment of Life and General Activity (PEG) scores, Patient Health Questionnaire-4 (PHQ-4), and TCM syndrome differentiation were evaluated. Comparative analysis was performed using mixed-effect models. Among 101 participants (HARMOKnee=50; SC=51), the mean age was 63.99 ± 7.03 years, and KOA duration was 5.07 ± 6.35 years. There was a significant intervention-time interaction, favouring HARMOKnee group, for the KOOS-12 total score Coef= 6.43, 95 %CI: 0.72, 12.14; p = 0.027, KOOS-12 quality of life (QOL) domain-score Coef= 8.50, 95 %CI: 1.28, 15.73; p = 0.021, and PEG overall score Coef= -1.32, 95 %CI: -2.14, -0.49; p = 0.002 at 6-week. No between-group differences were identified at other time-points. The HARMOKnee group demonstrated considerable pain reduction and improved knee flexion and extension after 12 treatments (0.001 < p < 0.014). This treatment approach markedly enhanced knee flexion in patients with Kidney yang deficiency with phlegm and blood stasis syndrome. HARMOKnee provides short-term pain-management benefits to KOA patients compared to standard care alone, particularly in patients with Kidney yang deficiency with phlegm and blood stasis syndrome.
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