Intrathecal Baclofen Therapy in Russia: National Register, the Effect of One-Year Usage

Patients with severe muscular spasticity still represent the most complex and resistant to therapy group of neuro-rehabilitation patients. In a few years, in Russia, intrathecal baclofen therapy has appeared to be the most effective method for such spasticity. For the first time the authors developed and implemented in clinical practice “Prospective register to treat spastic states using intrathecal baclofen therapy in Russian Federation” aimed at therapy classification of spastic patients: to reveal management characteristics, assess treatment outcomes and frequency of occurrence of adverse events that will finally help specify the need for the method employment in real clinical practice.

The article presents the findings of a one-year usage of Register, which enabled to make a preliminary evaluation of intrathecal baclofen therapy in Russia.

1. Morozov I.N., Ushakov A.I. ITB spasticity therapy. Poliklinika 2017; 4–2: 38–40.
2. Parfenov V.A. Post-stroke spasticity and its treatment. Russkiy meditsinskiy zhurnal 2006; 9: 689.
3. Francisco G.E., Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil 2003; 84(8): 1194–1199, https://doi.org/10.1016/s0003-9993(03)00134-5.
4. Ivanhoe C.B., Francisco G.E., McGuire J.R., Subramanian T., Grissom S.P. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil 2006; 87(11): 1509–1515, https://doi.org/10.1016/j.apmr.2006.08.323.
5. Meythaler J.M., Guin-Renfroe S., Brunner R.C., Hadley M.N. Intrathecal baclofen for spastic hypertonia from stroke. Stroke 2001; 32(9): 2099–2109, https://doi.org/10.1161/hs0901.095682.
6. Schiess M.C., Oh I.J., Stimming E.F., Lucke J., Acosta F., Fisher S., Simpson R.K. Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement. Neuromodulation 2011; 14(1): 38–45; https://doi.org/10.1111/j.1525-1403.2010.00308.x.
7. Becker R., Alberti O., Bauer B.L. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997; 244(3): 160–166, https://doi.org/10.1007/s004150050067.
8. Meythaler J.M., DeVivo M.J., Hadley M. Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. Arch Phys Med Rehabil 1996; 77: 461–466, https://doi.org/10.1016/s0003-9993(96)90034-9.
9. Meythaler J.M., Guin-Renfroe S., Grabb P., Hadley M.N. Long-term continuously infused intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999; 80(1): 13–19, https://doi.org/10.1016/s0003-9993(99)90301-5.
10. Ordia J.I., Fischer E., Adamski E., Spatz E.L. Continuous intrathecal baclofen infusion delivered by a programmable pump for the treatment of severe spasticity following traumatic brain injury. Neuromodulation 2002; 5(2): 103–107, https://doi.org/10.1046/j.1525-1403.2002.02015.x.
11. Albright A.L., Cervi A., Singletary J. Intrathecal baclofen for spasticity in cerebral palsy. JAMA 1991, 265: 1418–1422, https://doi.org/10.1001/jama.265.11.1418.
12. Butler C., Campbell S. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy. AACPDM Treatment Outcomes Committee Review Panel. Dev Med Child Neurol 2000; 42(9): 634–645, https://doi.org/10.1017/s0012162200001183.
13. Gilmartin R., Bruce D., Storrs B.B., Abbott R., Krach L., Ward J., Bloom K., Brooks W.H., Johnson D.L., Madsen J.R., McLaughlin J.F., Nadell J. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol 2000; 15(2): 71–77.
14. Simpson D.M., Gracies J.M., Graham H.K., Miyasaki J.M., Naumann M., Russman B., Simpson L.L., So Y. Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 70(19): 1691–1698, https://doi.org/10.1212/01.wnl.0000311391.00944.c4.
15. Lindsay C., Kouzouna A., Simcox C., Pandyan A.D. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database Syst Rev 2016; 10: CD010362, https://doi.org/10.1002/14651858.cd010362.pub2.
16. Jones R.F., Lance J.W. Baclofen (Lioresal) in the long-term management of spasticity. Med J Aust 1976; 654–657, https://doi.org/10.5694/j.1326-5377.1976.tb140942.x.
17. Gwartz B.L. Intrathecal baclofen for spasticity caused by thrombotic stroke. Am J Phys Med Rehabil 2001; 80(5): 383–387, https://doi.org/10.1097/00002060-200105000-00014.
18. Rémy-Néris O., Tiffreau V., Bouilland S., Bussel B. Intrathecal baclofen in subjects with spastic hemiplegia: assessment of the antispastic effect during gait. Arch Phys Med Rehabil 2003; 84(5): 643–650, https://doi.org/10.1016/s0003-9993(03)04906-7.
19. Medtronic ITB evidence compendium. Minneapolis, USA; 2017.
20. Creamer M., Cloud G., Kossmehl P., Yochelson M., Francisco G.E., Ward A.B., Wissel J., Zampolini M., Abouihia A., Berthuy N., Calabrese A., Loven M., Saltuari L. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry 2018; 89(6): 642–650, https://doi.org/10.1136/jnnp-2017-317021.
21. Vedenie bol’nykh s posledstviyami pozvonochnospinnomozgovoy travmy na vtorom i tret’em etapakh meditsinskoy i mediko-sotsial’noy reabilitatsii. Klinicheskie rekomendatsii [Management of patients with consequences of a spinal injury at the second and third stages of medical and medical-social rehabilitation. Clinical recommendations]. Pod red. Ivanovoy G.E., Volovets S.A., Morozova I.N. [Ivanova G.E., Volovets S.A., Morozov I.N. (editors)]. Moscow; 2017; 320 p.
22. Morozov I.N. Pozvonochno-spinnomozgovaya travma: vosstanovitel’noe lechenie v promezhutochnom i pozdnem periodakh. Avtoref. dis. … dokt. med. nauk [Spinal injury: rehabilitation treatment in the intermediate and late periods. DSc Thesis]. Nizhny Novgorod; 2011.
23. Bikmullin T.A., Levin M.S., Bariev E.R., Khakimova F.N. Features of treatment after of baklofen pump implantation. Prakticheskaya meditsina 2017; 1: 96–100.
24. Morozov I.N., Slavin K.V. Intrathecal baclofen therapy in Russia: National Register of Spastic States. Sovremennye tehnologii v medicine 2018; 10(4): 159–163, https://doi.org/10.17691/stm2018.10.4.19.

Filatov E.V., Biktimirov А.R., Simatov А.I., Tomsky А.А., Ushakov А.I., Timershin А.G., Krestchenok D.V., Levin М.S., Nesterin К.V., Kirsanova О.N., Posidelova Е.О., Vtorov А.V., Klochkov М.N., Polyakov А.Е., Semkin К.V., Siid Abla E.R., Morozov I.N. Intrathecal Baclofen Therapy in Russia: National Register, the Effect of One-Year Usage. Sovremennye tehnologii v medicine 2020; 12(1): 79, https://doi.org/10.17691/stm2020.12.1.10