Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial

Abstract Background: Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis during remission stage. Patients often have a slow course and long history of the disease. The refractory type of psoriasis is a stubborn rash that does not subside easily. We designed this randomized controlled trial to compare the effectiveness and relapse rates of plaque psoriasis in patients treated with either acupuncture, moxibustion or calcipotriol ointment. The ultimate aim of the study is to select an effective traditional Chinese medicine (TCM) therapy for patients with plaque psoriasis. Methods: The study will be a multi-center, prospective randomized controlled trial (RCT), which compares the effectiveness of fire needle therapy, moxibustion and calcipotriol ointment. 160 plaque psoriasis patients who meet the inclusion criteria will be recruited from three hospitals in Beijing, and then randomly assigned to receive either fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment (group B). All participants will receive a 8-week treatment and then be followed up for another 24 weeks, with the time point of the 12th and 24th week after treatment complete. The primary outcomes measured are relapse rates and Psoriasis area and severity index (PASI) score of the target lesions. In addition, the target lesion onset time, dermatology life quality index (DLQI), Traditional Chinese Medicine (TCM) syndrome score, and the relapse interval of the target lesion will be measured. Adverse events will be recorded for safety assessment. Discussion: This study is to determine whether fire needle therapy or moxibustion could improve the clinical effectiveness of psoriasis lesions and reduce the relapse rate. Once completed, it will provide information regarding therapeutic evaluation on fire needle therapy or moxibustion for plaque psoriasis, which will assist clinicians select the most effective treatment options for patients. Trial registration: ChiCTR1800019588; Pre-results; Registered on 19 November 2018; International Clinical Trials Registry Platform (ICTRP). URL: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR1800019588 Keywords: Fire needle therapy, Moxibustion, Plaque Psoriasis, Clinical effectiveness, Relapse rate