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

AbstractBackground: 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.