Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
Phase: NA
Conditions: Post-Stroke Upper Limb Spasticity
Sponsor: Mackay Memorial Hospital

Design: 
    This study is a prospective and single blinded randomized control trial. 
The inclusion or the exclusion criteria will be assessed by the same physician 
before the patients are invited to join the trial. After the selected patients have 
signed the informed consent sheets, they will be randomized into two groups 
(21 patients in each group), the radial shockwave therapy group (RSWT 
group), the botulinum toxin injection group, and the control group. The 
randomization will be generated by a computer program and the allocation will 
be done with concealed envelops. Both the patients and the examining 
physicians are blind to the allocation. Treatment will be performed by another 
independent physician. 
Participants: 
Totally, 42 patients will be recruited from the department of Physical 
Medicine and Rehabilitation of the Taipei MacKay Memorial Hospital. 
Eligible subjects should meet the following inclusion criteria: (1) aged 
between 18 ~ 80 years old; (2) at least 6 months since onset of last stroke; 
(3) having at least 1+ in modified Ashworth Scale (MAS) score at the spastic 
elbow; (4) most important of all, read and signed the inform concern of this 
study. 
The exclusion criteria are the following: (1) patients with elbow 
contracture (MAS=4); (2) patient who had prior history of botulinum toxin, 
phenol, alcohol injections, intrathecal baclofen pump or rhizotomy in six 
months; (3) having evidence of cognitive deficit; (4) having local infection, 
severe inflammation or otherwise lesion that is not suggestive for ESWT; (5) 
patient with serious medical problems, as uncontrolled hypertension, 

coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic 
disease, epilepsy, cutaneous pathology, mental retardation.  
During the study period, physical therapy including range of motion 
(ROM) exercises, stretching, and others remained unchanged. Also, the 
doses of medication which might affect spasticity were not changed. 
Interventions:  
For each group, totally 3 section of therapy will be given in an interval of 
one week. The shock wave will be given by a two combined ESWT device 
from which 3000 impulses of shock waves with energy flux density of 1.5 bars 
and frequency of 5 Hz are delivered in the radial shock wave therapy group. 
For botulinum toxin group, botulinum toxin ( dilution 500 U/2 mL in saline 
0.9%) was administered. For the control group, a sham probe will be 
contacting the skin with the same therapeutic sound made. However, no 
energy will be delivered from the sham probe. The location of the applied 
therapy will be at biceps, flexor carpi radialis (FCR) and flexor carpi ulnaris 
(FCU) muscles. 
Outcome measures: 
 The primary outcome of this study include, elbow andradio carpal joint 
range of motion (ROM), modified Ashworth scale (MAS), modified Tardieu 
scale (MTS), and Fugl-meyer assessment (FMA). The evaluation will be done 
before therapy sections, immediately, 1 month after, and 3 months after 3rd 
section of therapy. All examination will be done by the same examining 
physician who is blind to the allocation. 

Modified Ashworth scale (MAS). The definition of the measured scales 
were as that proposed by Bohannon and Smith.3 Briefly, elbow joint range of 
motion will be performed manually. MAS is graded by the resistance felt 
during passive range of motion. However, for convenience in the statistical 
analysis, MAS 1+ was substituted by scale of 2, and 2, 3, and 4 were 
substituted by 3, 4, and 5, respectively. 
Modified Tardieu scale (MTS). The definition of the measurement was as 
that proposed by Boyd and Graham (modified from Tardieu scale).4 5 In brief, 
the measurement of elbow and radio carpal  range of motion will be 
performed at a slow and a fast velocity. The resulted joint angles at two 
speeds will be measured by goniometer. R1 angle is defined as angle of 
catch after a fast speed stretch and R2 angle is defined as angle measured 
during slow speed range of motion. The average of three testing will be used 
for analysis. The quality of muscle reaction during measurement will also be 
scaled.  
Fugl-meyer assessment (FMA) The Fugl-Meyer assessment is designed to 
assess motor recovery following stroke. The maximum score of motor 
function of upper limbs were 66. It is a relatively simple assessment to 
administer and requires minimal training. The overall reliability for this 
instrument was high, as were the reliability measurements for the 
subsections of this assessment. 
Statistical analysis. 
All statistic data will be analyzed by SPSS statistical software, version 20.0 
(SPSS Inc., Chicago, USA). The homogeneity of patient demographic 

characteristics in both comparative groups A and B were calculated with 
chi-square test for qualitative variables (gender, stroke subtype, affected site) 
and the ANOVA test for quantitative variables (age, weight,height, body mass 
index [BMI], time since onset of stroke). The differences between 3 groups 
were investigated using the repeated measures ANOVA followed by the 
Bonferroni post hoc tests. Statistical significance was set at P<0.05.