SBOTE study: Extracorporeal shock wave therapy versus electrical stimulation after botulinum toxin type a injection for post-stroke spasticity-a prospective randomized trial

Ultrasound in Medicine and Biology

Volumn 39, Issue 2, 2013, Pages 283-291

  Santamato, Andrea ^a   Notarnicola, Angela ^b   Panza, Francesco ^c   Ranieri, Maurizio ^b   Micello, Maria Francesca ^a   Manganotti, Paolo ^d   Moretti, Biagio ^b   Fortunato, Francesca ^a   Filoni, Serena ^c   Fiore, Pietro ^a  

^a UNIVERSITY OF FOGGIA   (Italy)

^b UNIVERSITY OF BARI   (Italy)

^c CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^d UNIVERSITY OF VERONA   (Italy)

Author keywords

Botulinum toxin type A; Electrical stimulation; Extracorporeal shock wave therapy; Spasticity

Indexed keywords

PATIENT MONITORING; SHOCK WAVES;

BIOSTIMULATION; BOTULINUM TOXIN TYPE-A; BOTULINUM TOXINS; ELECTRICAL STIMULATIONS; EXTRACORPOREAL SHOCKWAVE THERAPY; FREQUENCY SCALE; NEUROMUSCULAR JUNCTIONS; POST TREATMENT; PROSPECTIVE RANDOMIZED TRIAL; RANDOMIZED CONTROLLED TRIAL; SPASTICITY; STROKE PATIENTS; UPPER LIMBS; VISUAL ANALOGUE SCALE;

TOXIC MATERIALS;

BOTULINUM TOXIN A;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COMPARATIVE STUDY; CONTROLLED STUDY; ELECTROSTIMULATION THERAPY; EXTRACORPOREAL LITHOTRIPSY; FEMALE; FOCAL UPPER LIMB SPASTICITY; FOLLOW UP; HUMAN; MALE; MODIFIED ASHWORTH SCALE; MUSCLE SPASM; PAIN; PATIENT CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SPASM FREQUENCY SCALE; SPASTICITY; STROKE PATIENT; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL ANALOG SCALE;

EID: 84871795409     PISSN: 03015629     EISSN: 1879291X     Source Type: Journal    
DOI: 10.1016/j.ultrasmedbio.2012.09.019     Document Type: Article

References (60)

1. Amelio E., Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: A placebo-controlled study. J Rehabil Med 2010, 42:339-343.
2. Ansari N.N., Adelmanesh F., Naghdi S., Tabtabaei A. The effect of physiotherapeutic ultrasound on muscle spasticity in patients with hemiplegia: A pilot study. Electromyogr Clin Neurophysiol 2006, 46:247-252.
3. Ansari N.N., Naghdi S., Bagheri H., Ghassabi H. Therapeutic ultrasound in the treatment of ankle plantar flexor spasticity in a unilateral stroke population: A randomized, single-blind, placebo-controlled trial. Electromyogr Clin Neurophysiol 2007, 47:137-143.
4. Aoki K.R. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. NeuroToxicology 2005, 26:785-793.
5. Bakhtiary A.H., Fatemy E. Does electrical stimulation reduce spasticity after stroke? A randomized controlled study. Clin Rehabil 2008, 22:418-425.
6. Baricich A., Carda S., Bertoni M., Maderna L., Cisari C. A single-blinded, randomized pilot study of botulinum toxin type A combined with non-pharmacological treatment for spastic foot. J Rehabil Med 2008, 40:870-872.
7. Bayram S., Sivrioglu K., Karli N., Ozcan O. Low-dose botulinum toxin with short term electrical stimulation in post-stroke spastic drop foot. Am J Phys Med Rehabil 2006, 85:75-81.
8. Blottner D., Luck G. Just in time and place: NOS/NO system assembly in neuromuscular junction formation. Microsc Res Tech 2001, 55:171-180.
9. Bohannon R.W., Smith M.B. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987, 67:206-207.
10. Brashear A., Gordon M.F., Elovic E., Kassicieh V.D., Marciniak C., Do M., Lee C.H., Jenkins S., Turkel C. Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002, 347:395-400.
11. Brown P. Pathophysiology of spasticity. Neurol Neurosurg Psychiatry 1994, 57:773-777.
12. Carda S., Molteni F. Taping versus electrical stimulation after botulinum toxin type a injection for wrist and finger spasticity. A case-control study. Clin Rehabil 2005, 19:621-626.
13. Das T.K., Park D.M. Effect of treatment with botulinum toxin on spasticity. Postgrad Med J 1989, 65:208-210.
14. Detrembleur C., Lejeune T.M., Renders A., Van Den Bergh P.Y. Botulinum toxin and short-term electrical stimulation in the treatment of equinus in cerebral palsy. Mov Desord 2002, 17:162-169.
15. Eleopra R., Tugnoli V., De Grandis D. The variability in the clinical effect induced by botulinum toxin type A: The role of muscle activity in humans. Mov Disord 1997, 12:89-94.
16. Esquenazi A., Mayer N. Electric stimulation to prolong the duration of botulinum toxin type A effect on spasticity: A double-blind, placebo- controlled study. Arch Phys Med Rehabil 2007, 88:E105.
17. Frasson E., Priori A., Ruzzante B., Didonè G., Bertolasi L. Nerve stimulation boots botulinum toxin action in spasticity. Mov Disord 2005, 20:624-629.
18. Grumelli C., Verderio C., Pozzi D., Rossetto O., Montecucco C., Matteoli M. Internalization and mechanism of action of clostridial toxins in neurons. Neurotoxicology 2005, 26:761-767.
19. Harvey R.L., Winstein C.J. Everest Trial Group. Design for the everest randomized trial of cortical stimulation and rehabilitation for arm function following stroke. Neurorehabil Neural Repair 2009, 23:32-44.
20. Hazlewood M.E., Brown J.K., Rowe P.J., Salter P.M. The use of therapeutic electrical stimulation in the treatment of hemiplegic cerebral palsy. Dev Med Child Neurol 1994, 36:661-673.
21. Hesse S., Reiter F., Konrad M., Jahnke M. Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: A randomized, double-blind, placebo-controlled trial. Clin Rehabil 1998, 12:381-388.
22. Iannone F., Moretti B., Notarnicola A., Moretti L., Patella S., Patella V., Lapadula G. Extracorporeal shock waves increase interleukin-10 expression by human osteoarthritic and healthy osteoblasts in vitro. Clin Exp Rheumatol 2009, 27:794-799.
23. Jaeschke R., Singer J., Guyatt G.H. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10:407-415.
24. Jost W.H., Kohl A., Brinkmann S., Comes G. Efficacy and tolerability of a botulinum toxin type A free of complexing proteins (NT 201) compared with commercially available botulinum toxin type A (BOTOX) in healthy volunteers. J Neural Transm 2005, 112:905-913.
25. Kamelger F., Oehlbauer M., Piza-Katzer H., Meirer R. Extracorporeal shock wave treatment in ischemic tissues: What is the appropriate number of shock wave impulses?. J Reconstr Microsurg 2010, 26:117-121.
26. Kang B.S., Bang M.S., Jung S.H. Effects of botulinum toxin A therapy with electrical stimulation on spastic calf muscles in children with cerebral palsy. Am J Phys Med Rehabil 2007, 86:901-906.
27. Lieber R.L., Steinman S., Barash I.A., Chambers H. Structural and functional changes in spastic skeletal muscle. Muscle Nerve 2004, 29:615-627.
28. Liepert J., Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis-A pilot study. Restor Neurol Neurosci 2010, 28:729-735.
29. Lin K.C., Fu T., Wu C.Y., Hsieh C.J. Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: Minimal detectable change and clinically important difference. Health Qual Life Outcomes 2011, 9:5.
30. Lohse-Busch H., Kraemer M., Reime U. A pilot investigation into the effects of extracorporeal shock waves on muscular dysfunction in children with spastic movement disorders. Schmerz 1997, 11:108-112.
31. 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.
32. Marconi B., Filippi G.M., Koch G., Giacobbe V., Pecchioli C., Versace V., Camerota F., Saraceni V.M., Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair 2011, 25:48-60.
33. Mariotto S., Cavalieri E., Amelio E., Campa A.R., Carcereri de Prati A., Marlinghaus E., Russo S., Suzuki H. Extracorporeal shock waves: From lithotripsy to anti-inflammatory action by NO production. Nitric Oxide 2005, 12:89-96.
34. Molina J.A., Jimenez-Jimenez F.J., Ortì-Pareja M., Navarro J.A. The role of nitric oxide in neurodegeneration. Potential for pharmacological intervention. Drugs Aging 1998, 12(4):251-259.
35. Montecucco C., Rossetto O., Schiavo G. Presynaptic receptor arrays for clostridial neurotoxins. Trends Microbiol 2004, 12:442-446.
36. Moretti B., Iannone F., Notarnicola A., Lapadula G., Moretti L., Patella V., Garofalo R. Extracorporeal shock waves down-regulate the expression of interleukin-10 and tumor necrosis factor-alpha in osteoarthritic chondrocytes. BMC Musculoskelet Disord 2008, 9:16.
37. Moretti B., Notarnicola A., Maggio G., Moretti L., Pascone M., Tafuri S., Patella V. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. BMC Musculoskelet Disord 2009, 10:54.
38. Notarnicola A., Moretti L., Tafuri S., Panella A., Filipponi M., Casalino A., Panella M., Moretti B. Shockwave therapy in the management of complex regional pain syndrome in medial femoral condyle of the knee. Ultrasound Med Biol 2010, 36:874-879.
39. Pham T., Lafforgue P. Reflex sympathetic dystrophy syndrome and neuromediators. Joint Bone Spine 2003, 70:12-17.
40. Picelli A., Smania N., Storti I., Munari D., Fontana C., Fiaschi A., Santilli V., Tamburin S. Immediate versus delayed electrical stimulation boosts botulinum toxin effect: A pilot study. Mov Disord 2011, 26:1784-1785.
41. Pizzi A., Carlucci G., Falsini C., Verdesca S., Grippo A. Evaluation of upper-limb spasticity after stroke: A clinical and neurophysiologic study. Arch Phys Med Rehabil 2005, 86:410-415.
42. Price D.D., Bush F.M., Long S., Harkins S.W. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 1994, 56:217-226.
43. Ravichandran E., Gong Y., Al Saleem F.H., Ancharski D.M., Joshi S.G., Simpson L.L. An initial assessment of the systemic pharmacokinetics of botulinum toxin. J Pharmacol Exper Ther 2006, 318:1343-1351.
44. Rha D.W., Yang E.J., Chung H.I., Kim H.B., Park C., Park E.S. Is electrical stimulation beneficial for improving the paralytic effect of botulinum toxin type A in children with spastic diplegic cerebral palsy?. Yonsei Med J 2008, 49:545-552.
45. Rompe J.D., Hopf C., Kullmer K., Heine J., Burger R. Analgesic effect of ESWT on chronic tennis elbow. J Bone Joint Surg Br 1996, 78B:233-237.
46. Rompe J.D., Kirkpatrick C.J., Kullmer K., Schwitalle M., Krischnek O. Dose-related effects of shock waves on rabbit tendo Achillis: A sonographic and histological study. J Bone Joint Surg Br 1998, 80(3):546-552.
47. Rosales R.L., Chua-Yap A.S. Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Transm 2008, 115:617-623.
48. Santus G., Faletti S., Bordanzi I., Pirali F., De Grandis D. Effect of short-term electrical stimulation before and after botulinum toxin injection. J Rehabil Med 2011, 43:420-423.
49. Schofer M.D., Hinrichs F., Peterlein C.D., Arendt M., Schmitt J. High- versus low-energy extracorporeal shock wave therapy of rotator cuff tendinopathy: A prospective, randomised, controlled study. Acta Orthop Belg 2009, 75:452-458.
50. Schwartzman R.J., Alexander G.M., Grothusen J. Pathophysiology of complex regional pain syndrome. Expert Rev Neurother 2006, 6:669-681.
51. Simpson D.M., Alexander D.N., O'Brien C.F., Tagliati M., Aswad A.S., Leon J.M., Gibson J., Mordaunt J.M., Monaghan E.P. Botulinum toxin type A in the treatment of upper extremity spasticity: A randomized, double blind, placebo controlled trial. Neurology 1996, 46:1306-1310.
52. Sjölund B.H. Pain and rehabilitation after spinal cord injury: The case of sensory spasticity?. Brain Res Brain Res Rev 2002, 40:250-256.
53. Snow B.J., Tsui J.K.C., Bhatt M.H., Varelas M., Hashimoto S.A., Calne D.B. Treatment of spasticity with botulinum toxin: A double blind study. Ann Neurol 1990, 28:512-515.
54. Tiele R. New Guidelines for ESWT. Newsletter ISMST 2009, 5:20.
55. Torii Y., Goto Y., Takahashi M., Ishida S., Harakawa T., Sakamoto T., Kaji R., Kozaki S., Ginnaga A. Quantitative determination of biological activity of botulinum toxins utilizing compound muscle action potentials (CMAP), and comparison of neuromuscular transmission blockage and muscle flaccidity among toxins. Toxicon 2010, 55:407-414.
56. Trompetto C., Avanzino L., Bove M., Marinelli L., Molfetta L., Trentini R., Abbruzzese G. External shock waves therapy in dystonia: Preliminary results. Eur J Neurol 2009, 16:517-521.
57. Watkins C.L., Leathley M.J., Gregson J.M., Moore A.P., Smith T.L., Sharma A.K. Prevalence of spasticity post stroke. Clin Rehabil 2002, 16:515-522.
58. Wissel J., Schelosky L.D., Scott J., Christe W., Faiss J.H., Mueller J. Early development of spasticity following stroke: A prospective, observational trial. J Neurol 2010, 257:1067-1072.
59. Wissel J., Ward A.B., Erztgaard P., Bensmail D., Hecht M.J., Lejeune T.M., Schnider P., Altavista M.C., Cavazza S., Deltombe T., Duarte E., Geurts A.C., Gracies J.M., Haboubi N.H., Juan F.J., Kasch H., Kätterer C., Kirazli Y., Manganotti P., Parman Y., Paternostro-Sluga T., Petropoulou K., Prempeh R., Rousseaux M., Slawek J., Tieranta N. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med 2009, 41:13-25.
60. Zhu Y., Xu J., Heinemann S.F. Two pathways of synaptic vesicle retrieval revealed by single vesicle imaging. Neuron 2009, 61:397-411.