Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial

Abstract

BackgroundConventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA.Methods/designThis is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation.DiscussionThis study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy.Trial registrationClinicalTrials.gov, NCT02772055. Registered on 12 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1846-2) contains supplementary material, which is available to authorized users.

Comparison of the Efficacy between Conventional Moxibustion and Smoke-Free Moxibustion on Knee Osteoarthritis: A Randomized Controlled Trial

“…We performed a multicentre, randomized, single blinded, parallel-group design clinical trial for 13 weeks from June, 2016, to May, 2017. The trial protocol adhered to the CONSORT (Consolidated Standards of Reporting Trails) and STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines [34] and has been published [23]. The institutional human ethics committee approved the study.…”

“…We used traditional Chinese medicine style of moxibustion. All project general practitioners (GPs) had completed at least 5 years of training in acupuncture and moxibustion, registered as Chinese medicine practitioner by the National Health and Family Planning Commission of the People's Republic of China [23]. Project GPs were trained for one day by an investigator who is an experienced medical acupuncturist, to standardise all aspects of the treatment protocol.…”

“…Selection of acupoints is based on TCM meridian theory to treat knee joint pain, known as the syndrome and some similar studies [13, 17, 18, 35, 36]. All patients received moxibustion on 3 obligatory points, including ExLE4, ST35, and ST36 [17, 23, 37]. Thirty-minute treatments were delivered 3 times per week, for 4 weeks, with 12 sessions in total permitted.…”

“…This clinical trials and review suggested that moxibustion could be beneficial for pain control in patients with KOA. The mechanism of moxibustion is mainly related to the thermal and radiation effects, pharmacological activity of moxa, and its combustion products (volatile oil, brown tar-like substances, and moxa smoke) [23]. Moxa smoke, as a primary combustion product of the moxibustion, with its potential effect on the health and environment may be controversial [23, 24].…”

“…The mechanism of moxibustion is mainly related to the thermal and radiation effects, pharmacological activity of moxa, and its combustion products (volatile oil, brown tar-like substances, and moxa smoke) [23]. Moxa smoke, as a primary combustion product of the moxibustion, with its potential effect on the health and environment may be controversial [23, 24]. A recent evidence summary of moxa smoke has antibacterial and antiviral effects to treat various conditions including wound infections, vaginal itching, uterine prolapse, anal fistula, and common warts [25–27].…”