Original research| Volume 99, ISSUE 11, P2143-2150, November 2018

Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial



      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.


      Randomized noninferiority trial.


      Referral medical center.


      Patients (N=42) with chronic stroke (28 men; mean age, 61.0±10.6y).


      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.


      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.


      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.


      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

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Archives of Physical Medicine and Rehabilitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Chan L.
        • Lin Y.-D.
        • Liu C.-H.
        World stroke day in Taiwan: raising public awareness of stroke.
        Int J Gerontol. 2016; 10: 175-179
        • Momosaki R.
        • Kakuda W.
        • Kinoshita S.
        • Yamada N.
        • Abo M.
        Clinical effectiveness of board-certificated physiatrists on functional recovery in elderly stroke patients during convalescence: a retrospective cohort study.
        Int J Gerontol. 2017; 11: 7-11
        • Noma T.
        • Matsumoto S.
        • Etoh S.
        • Shimodozono M.
        • Kawahira K.
        Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients.
        Brain Inj. 2009; 23: 623-631
        • Francisco G.E.
        • McGuire J.R.
        Poststroke spasticity management.
        Stroke. 2012; 43: 3132-3136
        • Esquenazi A.
        • Albanese A.
        • Chancellor M.B.
        • et al.
        Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper motor neuron syndrome.
        Toxicon. 2013; 67: 115-128
        • Rossetto O.
        • Pirazzini M.
        • Montecucco C.
        Botulinum neurotoxins: genetic, structural and mechanistic insights.
        Nat Rev Microbiol. 2014; 12: 535-549
        • Wissel J.
        • Ward A.B.
        • Erztgaard P.
        • et al.
        European consensus table on the use of botulinum toxin type A in adult spasticity.
        J Rehabil Med. 2009; 41: 13-25
        • Phadke C.P.
        • Balasubramanian C.K.
        • Holz A.
        • Davidson C.
        • Ismail F.
        • Boulias C.
        Adverse clinical effects of botulinum toxin intramuscular injections for spasticity.
        Can J Neurol Sci. 2016; 43: 298-310
        • Dressler D.
        Clinical presentation and management of antibody-induced failure of botulinum toxin therapy.
        Mov Disord. 2004; 19: S92-S100
        • Picelli A.
        • Bonetti P.
        • Fontana C.
        • et al.
        Is spastic muscle echo intensity related to the response to botulinum toxin type A in patients with stroke? A cohort study.
        Arch Phys Med Rehabil. 2012; 93: 1253-1258
        • Ogden J.A.
        • Toth-Kischkat A.
        • Schultheiss R.
        Principles of shock wave therapy.
        Clin Orthop Relat Res. 2001; 387: 8-17
        • Speed C.
        A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence.
        Br J Sports Med. 2014; 48: 1538-1542
        • Yin M.
        • Chen N.
        • Huang Q.
        • et al.
        New and accurate predictive model for the efficacy of extracorporeal shock wave therapy in managing patients with chronic plantar fasciitis.
        Arch Phys Med Rehabil. 2017; 98: 2371-2377
        • Carlisi E.
        • Lisi C.
        • Dall'angelo A.
        • et al.
        Focused extracorporeal shock wave therapy combined with supervised eccentric training for supraspinatus calcific tendinopathy.
        Eur J Phys Rehabil Med. 2018; 54: 41-47
        • Li T.Y.
        • Chang C.Y.
        • Chou Y.C.
        • et al.
        Effect of radial shock wave therapy on spasticity of the upper limb in patients with chronic stroke: a prospective, randomized, single blind, controlled trial.
        Medicine (Baltimore). 2016; 95: e3544
        • Manganotti P.
        • Amelio E.
        Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke.
        Stroke. 2005; 36: 1967-1971
        • Daliri S.S.
        • Forogh B.
        • Emami Razavi S.Z.
        • Ahadi T.
        • Madjlesi F.
        • Ansari N.N.
        A single blind, clinical trial to investigate the effects of a single session extracorporeal shock wave therapy on wrist flexor spasticity after stroke.
        NeuroRehabilitation. 2015; 36: 67-72
        • Santamato A.
        • Notarnicola A.
        • Panza F.
        • et al.
        SBOTE study: extracorporeal shock wave therapy versus electrical stimulation after botulinum toxin type a injection for post-stroke spasticity-a prospective randomized trial.
        Ultrasound Med Biol. 2013; 39: 283-291
        • Guo P.
        • Gao F.
        • Zhao T.
        • Sun W.
        • Wang B.
        • Li Z.
        Positive effects of extracorporeal shock wave therapy on spasticity in poststroke patients: a meta-analysis.
        J Stroke Cerebrovasc Dis. 2017; 26: 2470-2476
        • Svehlik M.
        • Zwick E.B.
        • Steinwender G.
        • Kraus T.
        • Linhart W.E.
        Dynamic versus fixed equinus deformity in children with cerebral palsy: how does the triceps surae muscle work?.
        Arch Phys Med Rehabil. 2010; 91: 1897-1903
        • Heckmatt J.Z.
        • Leeman S.
        • Dubowitz V.
        Ultrasound imaging in the diagnosis of muscle disease.
        J Pediatr. 1982; 101: 656-660
        • Sheean G.
        • Lannin N.A.
        • Turner-Stokes L.
        • Rawicki B.
        • Snow B.J.
        • Cerebral Palsy Institute
        Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: international consensus statement.
        Eur J Neurol. 2010; 17: 74-93
        • Yablon S.A.
        • Brin M.F.
        • VanDenburgh A.M.
        • et al.
        Dose response with onabotulinumtoxinA for post-stroke spasticity: a pooled data analysis.
        Mov Disord. 2011; 26: 209-215
        • Bohannon R.W.
        • Smith M.B.
        Interrater reliability of a modified Ashworth scale of muscle spasticity.
        Phys Ther. 1987; 67: 206-207
        • Li F.
        • Wu Y.
        • Li X.
        Test-retest reliability and inter-rater reliability of the Modified Tardieu Scale and the Modified Ashworth Scale in hemiplegic patients with stroke.
        Eur J Phys Rehabil Med. 2014; 50: 9-15
        • Woodbury M.L.
        • Velozo C.A.
        • Richards L.G.
        • Duncan P.W.
        • Studenski S.
        • Lai S.M.
        Longitudinal stability of the Fugl-Meyer Assessment of the upper extremity.
        Arch Phys Med Rehabil. 2008; 89: 1563-1569
        • Althunian T.A.
        • de Boer A.
        • Klungel O.H.
        • Insani W.N.
        • Groenwold R.H.
        Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review.
        Trials. 2017; 18: 107
        • Saper R.B.
        • Lemaster C.
        • Delitto A.
        • et al.
        Yoga, physical therapy, or education for chronic low back pain: a randomized noninferiority trial.
        Ann Intern Med. 2017; 167: 85-94
        • Dong Y.
        • Wu T.
        • Hu X.
        • Wang T.
        Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analysis and trial sequential analysis.
        Eur J Phys Rehabil Med. 2017; 53: 256-267
        • Nam H.S.
        • Park Y.G.
        • Paik N.J.
        • et al.
        Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial.
        J Neurol Sci. 2015; 357: 192-197
        • Mariotto S.
        • Cavalieri E.
        • Amelio E.
        • et al.
        Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production.
        Nitric Oxide. 2005; 12: 89-96
        • Mariotto S.
        • de Prati A.C.
        • Cavalieri E.
        • Amelio E.
        • Marlinghaus E.
        • Suzuki H.
        Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action.
        Curr Med Chem. 2009; 16: 2366-2372
        • Leone J.A.
        • Kukulka C.G.
        Effects of tendon pressure on alpha motoneuron excitability in patients with stroke.
        Phys Ther. 1988; 68: 475-480
        • Vattanasilp W.
        • Ada L.
        • Crosbie J.
        Contribution of thixotropy, spasticity, and contracture to ankle stiffness after stroke.
        J Neurol Neurosurg Psychiatry. 2000; 69: 34-39
        • El-Shamy S.M.
        • Eid M.A.
        • El-Banna M.F.
        Effect of extracorporeal shock wave therapy on gait pattern in hemiplegic cerebral palsy: a randomized controlled trial.
        Am J Phys Med Rehabil. 2014; 93: 1065-1072
        • Costantino C.
        • Galuppo L.
        • Romiti D.
        Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial.
        Eur J Phys Rehabil Med. 2017; 53: 32-40
        • Coroian F.
        • Jourdan C.
        • Bakhti K.
        • et al.
        Upper limb isokinetic strengthening versus passive mobilization in patients with chronic stroke: a randomized controlled trial.
        Arch Phys Med Rehabil. 2018; 99: 321-328
        • Lim Y.H.
        • Choi E.H.
        • Lim J.Y.
        Comparison of effects of botulinum toxin injection between subacute and chronic stroke patients: a pilot study.
        Medicine (Baltimore). 2016; 95: e2851
        • Hu G.C.
        • Chuang Y.C.
        • Liu J.P.
        • Chien K.L.
        • Chen Y.M.
        • Chen Y.F.
        Botulinum toxin (Dysport) treatment of the spastic gastrocnemius muscle in children with cerebral palsy: a randomized trial comparing 2 injection volumes.
        Clin Rehabil. 2009; 23: 64-71
        • Vetrano M.
        • d'Alessandro F.
        • Torrisi M.R.
        • Ferretti A.
        • Vulpiani M.C.
        • Visco V.
        Extracorporeal shock wave therapy promotes cell proliferation and collagen synthesis of primary cultured human tenocytes.
        Knee Surg Sports Traumatol Arthrosc. 2011; 19: 2159-2168