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

Abstract

Objective This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM 10 ), 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.

Clinical Effect of Hufu Copper Scraping on Shoulder-Hand Syndrome after Stroke

“…Previous studies have shown [19] that CGRP is a neuropeptide belonging to the calcitonin gene-related peptide family, which is highly expressed in peripheral sensory nerves and the central nervous system, and is involved in the transmission of nociceptive information and the formation of pain sensitization in the periphery and the spinal cord, and interacts with biologically active substances or receptors such as substance P in the process of pain modulation, which has a strong vasodilatory effect. Some studies have shown [20] that the change of CGRP level is related to the severity of nerve damage after hemorrhagic stroke, and it is also an important indicator for evaluating the prognosis of hemorrhagic stroke.…”

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

“…We read with great interest the recent article “Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial” 1 published by Xiaonan Meng et al in the Journal of Pain Research. By reading this article attentively, I would like to share some thoughts and personal understanding to this article.…”

DataSheet1.PDF

“…In the high MSC group, all four devices will each contain one lit stick of conventional moxa. Each moxibustion treatment will last for 20 minutes per session, with 5 weekly sessions being conducted over the course of 6 weeks [413] ① Based on the 2018 Chinese guideline for the diagnosis and treatment of rheumatoid arthritis, patients in both groups will be administered 12.5 mg methotrexate once per week (2.5 mg/pill, 030170202, SPH Sine Pharmaceutical Laboratories Co., Ltd, Shanghai, China). An additional 2.5 mg of methotrexate will be administered if patients experience uncontrolled pain, swelling or stiffness.…”