scholarly journals Effects of Radial Extracorporeal Shock Wave Therapy on Flexor Spasticity of the Upper Limb in Post-stroke Patients: Study Protocol for A Randomized Controlled Trial

2020 ◽  
Author(s):  
Tao Fan ◽  
Xiangying Zhou ◽  
Peichen He ◽  
Xiaojia Zhan ◽  
Peng Zheng ◽  
...  

Abstract Background: Flexor Spasticity of the Upper Limb is common in post-stroke patients and seriously affects the recovery of upper limb function. However, there are no standard management protocols for this condition. Radial extracorporeal shock wave therapy (rESWT) is widely used as a non-invasive treatment method for various diseases, but its efficacy in reducing spasticity remains undefined. Methods/design: A prospective, randomized, double-blind controlled trial is to be performed to study the efficacy of rESWT on the treatment of upper limb spasticity after strokes. One hundred participants will be recruited from the Inpatient department of Zhujiang hospital for this study. Patients who meet the inclusion criteria will be randomly allocated to either receive 3 sessions of active rESWT (Group A) or sham-placebo rESWT (Group B) with three day intervals between each session. Assessment will be performed at baseline and at each of the post-rESWT time points (t1, t2 and t3). The primary assessment outcome will be the Modified Ashworth Scale, while the secondary assessment outcomes will include surface electromyography, MyotonPRO digital muscle function evaluation and infrared thermal imaging. Discussion: This trial is aimed at analyzing the application of rESWT for the management of spasticity after stroke via comprehensive and quantitative assessments. We hypothesized that after receiving active rESWT, patients will show greater improvement of upper limb muscles, compared with patients of the sham-placeborESWT group. The rESWT would be an attractive alternative to traditional methods and the results of this study may provide guidance and support for the further study of potential mechanisms.

2021 ◽  
Vol 12 ◽  
Author(s):  
Tao Fan ◽  
Xiangying Zhou ◽  
Peichen He ◽  
Xiaojia Zhan ◽  
Peng Zheng ◽  
...  

Background: Flexor spasticity of the upper limb is common in poststroke patients and seriously affects the recovery of upper limb function. However, there are no standard management protocols for this condition. Radial extracorporeal shock wave therapy (rESWT) is widely used for various diseases, some studies reported the effects of ESWT on reducing spasticity, but the mechanism of ESWT to reduce spasticity by affecting the excitability of stretch reflex or non-neural rheological components in spastic muscles or both is not yet clear. A large randomized controlled trial with comprehensive evaluation indicators is still needed. The study is to observe the effect of rESWT on flexor spasticity of the upper limb after stroke and explore its mechanism.Methods: A prospective, randomized, double-blind controlled trial is to be performed. One hundred participants will be recruited from the Inpatient Department of Zhujiang Hospital. Eligible patients will be randomly allocated to either receive three sessions of active rESWT (group A) or sham-placebo rESWT (group B) with 3-day intervals between each session. Assessment will be performed at baseline and at 24 h after each rESWT (t1, t2, and t3). The primary assessment outcome will be the Modified Ashworth Scale, and other assessments include surface electromyography, MyotonPRO digital muscle function evaluation, and infrared thermal imaging. All data will be analyzed using intention-to-treat principles. Multiple imputation by chained equations will be used to address missing data caused by loss to follow-up and nonresponses. Per protocol, analyses will also be performed on the participants who complete other assessments. Statistical analysis will be performed using SPSS software (version 20.0) and the significance level set at p < 0.05.Discussion: This trial aims to analyze the application of rESWT for the management of spasticity after stroke via appropriate assessments. We hypothesized that after receiving active rESWT, patients would show greater improvement of upper limb muscles compared with patients within the sham-placebo group. The rESWT would be an alternative to traditional methods, and the results of this study may provide support for the further study of potential mechanisms.Clinical Trial Registration:www.chictr.org.cn, identifier: ChiCTR1800016144.


2021 ◽  
Vol 48 (1) ◽  
Author(s):  
Samar Abd Alhamed Tabra ◽  
Mohammad Ibrahim Zaghloul ◽  
Doaa Shawky Alashkar

Abstract Background Stroke patients often present with upper limb spasticity which impairs the functional status of patients. Recently, extracorporeal shock wave therapy (ESWT) is reported to be a safe, non-invasive, alternative treatment for spasticity. Many articles have been published on the effect of ESWT on lower limb spasticity, but only few of them had focused on upper limb spasticity, so the aim of this study is to evaluate the clinical and electrophysiological effect of ESWT on wrist and hand spasticity of chronic stroke patients and its impact on functional performance. In this monocentric study, forty chronic stroke patients with upper limb spasticity were recruited and randomly allocated into two groups. Both groups continued to receive conventional stroke rehabilitative program, while group I received three sessions of radial extracorporeal shock wave therapy (rESWT) 1 week apart. Results There was a significant decrease in wrist and hand spasticity after treatment and at follow-up in group I compared to group II (Modified Ashworth Scale after rESWT 1.45 ± 0.16, 2.90 ± 0.18 and follow-up 1.55 ± 0.13, 3.00 ± .0.15 in groups I and II, respectively). Also, there was a significant improvement of wrist control and hand function after treatment and at follow-up in group I compared to group II (p < 0.001). The improvement of pinch grip was noticed at follow-up with a significant difference relative to baseline in group I (p < 0.05). Hmax/Mmax ratio was significantly decreased at follow-up in group I compared to group II (p < 0.001). Conclusion ESWT is a valuable adjuvant treatment for spasticity of the hand and wrist in stroke patients which is reflected as improvement of functional activity. Trial registration ClinicalTrials.gov, NCT04312581. Registered on 18 March 2020.


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