FYI.
Authors Meng X , Sun J, Liu Q, Huang Y, Qiu X, Seto DJ, Li Y, Wang L, Li C, Gao S, Yu H, Zhao J, Zhao B
Received 4 November 2022
Accepted for publication 19 January 2023
Published 13 February 2023
Volume 2023:16 Pages 407—420
DOI https://doi.org/10.2147/JPR.S396195
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication:
Dr Houman Danesh
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 Zhao
1 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 work
Correspondence: Jiping Zhao; Baixiao Zhao, Email zjp7883@sina.com; baixiao100@vip.sina.com
Background:
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.
Annika Sefastsson
Therése Brändström
Håkan Littbrand3
Ann Sörlin
Xiaolei Hu
