Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial

Abstract

Xiaonan Meng,1 Liping Wang,1 Chunying Li,1 Sen Gao,2 Haikuo Yu,3 Lufen Zhang,4 Jie Sun5 1Acupuncture Department, Beijing Huguosi TCM Hospital, affiliated with Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 2Rehablitation Department, Beijing Huguosi TCM Hospital, affiliated with Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 3Rehabilitation Department, Xuanwu Hospital Capital Medical University, Beijing, People’s Republic of China; 4School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 5Rehabilitation Department of Integrated Chinese and Western Medicine, Beijing Xiaotangshan Hospital, Beijing, People’s Republic of ChinaCorrespondence: Jie Sun, Rehabilitation Department of Integrated Chinese and Western Medicine, Beijing Xiaotangshan Hospital, No. 390 Spring Road, Changping District, Beijing, 102211, People’s Republic of China, Email [email protected]: This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM10), on pain and motor dysfunction in patients with stage 1 post-stroke shoulder-hand syndrome (SHS).Materials and Methods: In this multi-center, sham-controlled, single-blind, randomized controlled trial (RCT), a total of 140 eligible patients with stage 1 post-stroke SHS will be recruited from March 2022 to February 2023 and randomly allocated to five groups in a ratio of 1:1:1:1:1. Moxibustion, in addition to standard medical care, will be applied to subjects in all groups. No acupoints on the affected upper limb will be utilized. Moxibustion smoke therapy, with varying levels of MSC, will be applied to the five groups as follows: (A) sham control group, (B) zero MSC group, (C) low MSC group, (D) medium MSC group, and (E) high MSC group. Patients in each group will be treated for 20 minutes per session, with five sessions each week, over a course of six weeks, with a total follow-up interval of eight weeks. The primary outcome measure will be a visual analog scale (VAS) assessment of the intensity of regionalized pain in the affected upper limb. Secondary outcome measures will include scoring on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI) and the measurement of somatosensory evoked potential (SEP). All participants will be evaluated before treatment, during treatment (ie, at two weeks and four weeks), immediately after concluding treatment (ie, at six weeks) and at two weeks post-treatment (ie, at eight weeks). Intention-to-treat analysis will be applied.Trial Registration Number: ChiCTR2100043076.Keywords: moxibustion smoke concentration, shoulder-hand syndrome, stroke, protocol, randomized controlled trial

Keywords

• moxibustion smoke concentration
• shoulder-hand syndrome
• stroke
• protocol
• randomized controlled trial