Abstract
Objective
To investigate whether extracorporeal shock wave therapy (ESWT) is noninferior to
botulinum toxin type A (BoNT-A) for the treatment of poststroke upper limb spasticity.
Design
Randomized noninferiority trial.
Setting
Referral medical center.
Participants
Patients (N=42) with chronic stroke (28 men; mean age, 61.0±10.6y).
Interventions
Patients received either ESWT or BoNT-A. During the study period, all patients continued
their regular rehabilitation.
Main Outcome Measures
Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention.
The primary outcome was the change from baseline of the modified Ashworth scale (MAS)
score of the wrist flexors at week 4. Secondary outcomes included the change of the
MAS scores, Tardieu angles of the wrist and elbow flexors, wrist and elbow passive
range of motion (PROM), and upper extremity Fugl-Meyer Assessment (UE-FMA) score during
the study period, as well as the treatment response rate.
Results
The primary outcome result in the ESWT group (−0.80±0.41) was similar to that in the
BoNT-A group (−0.90±0.44), with a higher confidence limit (0.4) for the difference
between groups within the prespecified margin of 0.5, indicating the noninferiority
of ESWT to BoNT-A. The response rate was not significantly different between the 2
groups. Both groups showed significant improvement in secondary outcomes relative
to baseline; however, the ESWT group yielded greater improvement in wrist and elbow
PROM and UE-FMA score.
Conclusion
Our results suggest that ESWT is a noninferior treatment alternative to BoNT-A for
poststroke upper limb spasticity. ESWT and BoNT-A caused similar reduction in spasticity
of the wrist and elbow flexors; however, ESWT yielded greater improvement in wrist
and elbow PROM and UE-FMA score.
Keywords
List of abbreviations:
BoNT-A (botulinum toxin type A), ESWT (extracorporeal shock wave therapy), MANOVA (multivariate analyses of variance), MAS (modified Ashworth scale), PROM (passive range of motion), UE-FMA (upper extremity Fugl-Meyer Assessment)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: July 03, 2018
Footnotes
Supported by research grants from the Ministry of Science and Technology in Taiwan (MOST-106-2314-B-195-009).
Clinical Trial Registration No.: NCT0313791.
Disclosures: none.
Identification
Copyright
© 2018 by the American Congress of Rehabilitation Medicine
