European Journal of Integrative Medicine | 2019
Moxibustion intervention for patients with ankylosing spondylitis: A study Protocol for a pilot randomized controlled trial
Abstract
Abstract Introduction Moxibustion is described as a technique that applies heat which is generated by burning herbal preparations containing Artemisia vulgaris to stimulate acupuncture points. The aim of this study is to assess the efficacy and safety of moxibustion treatment for AS. In the future, a larger RCT will be conducted based on preliminary data from this study. Methods This research is a protocol for an open, assessor- and analyst-blinded, randomized clinical trial with two parallel groups. Participants who meet the modified New York criteria for AS will be randomly allocated to the intervention group or the control group with a 1:1 allocation ratio. The intervention group will receive moxibustion intervention for 3 weeks and follow-up for 6 weeks. The control group will not receive moxibustion intervention and will be followed for 6 weeks. Conventional interventions will be allowed for both groups. Primary outcome measures are BASFI, BASDAI, and BASMI. Secondary outcome measures are SF-36, EQ-5D, ASQoL and serum levels of ESR and CRP. Ethics and dissemination This protocol has been approved by the Institutional Review Board (IRB) of the Clinical Research Centre (Affiliated Hospital of Nanjing University of Chinese Medicine, IRB No. [2018] YK006-01). In addition, results of this preliminary study will be disseminated through peer-reviewed publications.