Efficacy and Safety of a Novel Plum Blossom Needling with Mild Moxibustion Device for Upper Limb Pain Disorder and Motor Dysfunction in Patients with Stage 1 Post-Stroke Shoulder-Hand Syndrome: Study Protocol for a Multi-Center, Single-Blind, Randomized Sham-Controlled Trial

Xiaonan Meng,1,2,* Jie Sun,3,* Qi Liu,4,* Yueping Huang,5 Xianwen Qiu,6 David Jung Seto,7,8 Ying Li,3 Liping Wang,2 Chunying Li,2 Sen Gao,9 Haikuo Yu,10 Jiping Zhao,1 Baixiao Zhao1 1Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 2Department of Acupuncture and Moxibustion, Beijing Huguosi TCM Hospital, Affiliated with Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 3Department of Integrated Chinese and Western Medicine Rehabilitation, Beijing Xiaotangshan Hospital, Beijing, People’s Republic of China; 4Department of General Internal Medicine, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China; 5School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 6Department of Acupuncture and Moxibustion, Beijing Shichahai Community Healthcare Center, Beijing, People’s Republic of China; 7Division of Integrative Medicine, Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA; 8Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA; 9Department of Rehabilitation, Beijing Huguosi TCM Hospital, affiliated with Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 10Rehabilitation Department, Xuanwu Hospital Capital Medical University, Beijing, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jiping Zhao; Baixiao Zhao, Email zjp7883@sina.com; baixiao100@vip.sina.comBackground: Post-stroke shoulder-hand syndrome (PS-SHS), a common neurological comorbidity after stroke episodes, poses a grave threat on patients’ functional recovery. Preliminary trials have demonstrated that the acupuncture and moxibustion treatment, including a dermal acupuncture tapping method known as plum blossom needling (PBN) can improve pain and motor dysfunctions in patients with PS-SHS. However, there are few reports describing simultaneous moxibustion treatment in combination with PBN. Hence, a novel plum blossom needle device with mild moxibustion (PBNMM) was developed to evaluate its potential efficacy and safety in patients with stage 1 PS-SHS.Materials and Methods: This multicenter, sham-controlled, randomized controlled trial (RCT) will recruit 102 eligible patients with stage 1 PS-SHS from three clinical centers, randomly allocated in a ratio of 1:1:1 to the PBNMM group, PBNMM with no moxa smoke (PBNMM-NMS) group and sham control group. Patients in each group will receive a 30-minute treatment once per day for 4 weeks, with 5 consecutive sessions per week, for a total of 20 sessions. The primary outcome measure will be defined as the decreased scores from baseline in the visual analog scale (VAS) assessment at week 4. Secondary outcome measures will include scores on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI), and the somatosensory evoked potential (SEP) records. All outcomes will be evaluated at baseline and weeks 4, 5, 6 and 10, and the intention-to-treat analysis will be applied.Conclusion: This study aims to provide robust evidence for the efficacy and safety of the PBNMM for PS-SHS treatment, as well as the specific impact of moxibustion smoke itself in dealing with PS-SHS.Clinical Trial Registration: Chinese Clinical Trial Registry No. ChiCTR2200062441. Registered on 7 August 2022.Keywords: plum blossom needling, mild moxibustion, novel device, post-stroke shoulder-hand syndrome, protocol, randomized controlled trial