The design and protocol of heat-sensitive moxibustion for knee osteoarthritis: a multicenter randomized controlled trial on the rules of selecting moxibustion location

Abstract

BackgroundKnee osteoarthritis is a major cause of pain and functional limitation. Complementary and alternative medical approaches have been employed to relieve symptoms and to avoid the side effects of conventional medication. Moxibustion has been widely used to treat patients with knee osteoarthritis. Our past researches suggested heat-sensitive moxibustion might be superior to the conventional moxibustion. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion or conventional drug treatment.MethodsThis study consists of a multi-centre (four centers in China), randomised, controlled trial with three parallel arms (A: heat-sensitive moxibustion; B: conventional moxibustion; C: conventional drug group). The moxibustion locations are different from A and B. Group A selects heat-sensitization acupoint from the region consisting of Yin Lingquan(SP9), Yang Lingquan(GB34), Liang Qiu(ST34), and Xue Hai (SP10). Meanwhile, fixed acupoints are used in group B, that is Xi Yan (EX-LE5) and He Ding (EX-LE2). The conventional drug group treats with intra-articular Sodium Hyaluronate injection. The outcome measures above will be assessed before the treatment, the 30 days of the last moxibustion session and 6 months after the last moxibustion session.DiscussionThis trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It will provide evidence for the effectiveness of moxibustion as a treatment for moderate and severe knee osteoarthritis. Moreover, the result will clarify the rules of heat-sensitive moxibustion location to improve the therapeutic effect with suspended moxibustion, and propose a new concept and a new theory of moxibustion to guide clinical practices.Trial RegistrationThe trial is registered at Controlled Clinical Trials: ChiCTR-TRC-00000600.

Comparative Effectiveness of the Deqi Sensation and Non-Deqi by Moxibustion Stimulation: A Multicenter Prospective Cohort Study in the Treatment of Knee Osteoarthritis

“…Among the sensations typically associated with the Deqi, penetrating heat, expanding heat, and transmitting heat were most common [22]. Being consistent with their prominent roles in TCM, bilateral Xi Yan (EX-LE5) and He Ding (EX-LE2) showed the most prominent sensations [13, 21]. …”

“…Previous studies manifested that the Deqi (heat-sensitive moxibustion sensation) was elicited in 70% of the moxibustion procedures of patients [21]. The frequency and intensity of individual sensations were significantly higher in KOA.…”

“…Substantial evidence has supported that moxibustion stimulates a unique of Deqi, that is, heat-sensitive moxibustion sensation [11]. A lot of observations and researches were adopted to confirm this phenomenon in the 1990s [12]. …”

Warming Moxibustion Relieves Chronic Visceral Hyperalgesia in Rats: Relations to Spinal Dynorphin and Orphanin-FQ System

“…All of these archaeological investigations were the embryonic form of moxibustion therapy and also the beginning of moxibustion analgesia [32]. It has been shown that moxibustion could effectively treat human primary dysmenorrheal [33], knee osteoarthritis [34], rheumatoid arthritis [35], and cancer pain [36]. However, the mechanisms of moxibustion analgesia are not elucidated.…”

Influence of the Deqi Sensation by Suspended Moxibustion Stimulation in Lumbar Disc Herniation: Study for a Multicenter Prospective Two Arms Cohort Study

“…In the process of moxibustion treatment, the researchers discovered that, when human body is in morbid condition, related acupuncture points were quite sensitive to moxa's heat and produced nonlocal or nonsuperficial heat sensation, such as penetrating heat, expanding heat, and transmitting heat [15]. This phenomenon resembles the one that occurs when the Deqi appears after moxibustion rather than local heat sensation and surface glow of the skin.…”