Deans' stroke musings: 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

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Monday, February 13, 2023

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

FYI.

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

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

Download Article [PDF]

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 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.