Intrathecal baclofen pump for the treatment of severe spasticity – 15 years of experience

Czech version

Authors: S. Vaneková ¹; S. Tóth ¹; M. Melišek ²; J. Vanko ²; P. Harangozó ²; B. Rudinský ²
Authors‘ workplace: Klinika fyziatrie, balneológie a liečebnej rehabilitácie FN s poliklinikou Nové Zámky, Slovensko ¹; Neurochirurgická klinika FN s poliklinikou Nové Zámky, Slovensko ²
Published in: Cesk Slov Neurol N 2019; 82(4): 430-436
Category: Original Paper
doi: https://doi.org/10.14735/amcsnn2019430

Overview

Aim: Severe spasticity as a result of the affected CNS is difficult to be influenced by standard therapies in a number of cases. In recent years, continuous administration of baclofen in the intrathecal space using a pump system has proven to be effective. In this paper, we evaluate our experience with baclofen pump implantation from the aspect of this method’s safety and efficacy.

Patients and methods: 24 patients, median age 36 (30 -51) years, with a history of severe, intractable spasticity due to spinal cord injury (13 cases), multiple sclerosis (7 cases) and other cerebrospinal aetiology (4 cases), who underwent baclofen pump implantation. Spasticity was assessed using clinical scales (Ashworth Scale, Spasm Frequency Scale, Adductor Tone Rating) before and after titrating the effective dose of baclofen after pump implantation. Functional benefits were evaluated with Barthel Index before, 1 year, 5 and 10 years after implantation of the baclofen pump.

Results: During a follow up period with a median of 92 (41 -136) months, no death was noted. Nobody suffered from any new neurological impairment as a result of baclofen pump implantation. All patients presented with statistically significant improvement of spasticity and reduction of spasm frequency. We documented statistically significant improvement in functional status according to the Barthel Index 1, 5 and 10 years after pump implantation.

Conclusion: Intrathecal baclofen pump infusion is a safe and very effective method of treatment for intractable spasticity, which leads to functional improvement by increasing independence in daily living activities.

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

鞘内注射巴氯芬泵治疗严重痉挛– 15年的经验

目的：在许多病例中，受影响的中枢神经系统的严重痉挛很难受到标准疗法的影响。近年来，使用泵系统在鞘内持续给药巴氯芬被证明是有效的。本文就巴氯芬泵植入术的安全性和有效性进行评价。

患者和方法：24例患者，中位年龄36(30 -51)岁，有脊髓损伤引起的严重、顽固性痉挛(13例)、多发性硬化(7例)等脑脊液病因学(4例)病史，行巴氯芬泵植入式手术。采用临床量表(Ashworth量表、痉挛频率量表、内收肌张力分级)对泵植入式巴氯芬有效剂量滴定前后的痉挛状态进行评估。使用Barthel指数评估巴氯芬泵植入前、植入后1年、植入后5年和植入后10年的功能疗效。

结果：在平均92个月(41 -136个月)的随访期间，未发现死亡病例。没有人因为巴氯芬泵的植入而出现任何新的神经损伤。所有患者均有统计学意义的痉挛改善和痉挛频率降低。我们根据植入泵后1年、5年和10年的Barthel指数记录了功能状态的显著改善。结论：鞘内注射巴氯芬泵是治疗顽固性痉挛的一种安全有效的方法，可通过增加日常生活活动的独立性来改善功能。

关键词：痉挛–脊髓损伤–多发性硬化–鞘内巴氯芬–巴氯芬泵

Keywords:

spasticity – spinal cord injury – Multiple sclerosis – intrathecal baclofen – baclofen pump

Sources

1. Lance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP (eds.). Spasticity: disordered motor control. Chicago: Yearbook Medical 1980: 485–494.

2. Maynard FM, Karunas RS, Waring WP 3rd. Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil 1990; 71(8): 566–569.

3. Noreau L, Proulx P et al. Secondary impairments after spinal cord injury: a population-based study. Am J Phys Med Rehabil 2000; 79(6): 526–535.

4. Rizzo MA, Hadjimichael OC, Preiningerova J et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10(5): 589–595. doi: 10.1191/ 1352458504ms1085oa.

5. Wichers MJ, Odding E, Stam HJ et al. Clinical presentation, associated disorders and aetiological moments in Cerebral Palsy: a Dutch population-based study. Disabil Rehabil 2005; 27(10): 583–589. doi: 10.1080/ 09638280400018445.

6. Watkins CL, Leathley MJ, Gregson JM et al. Prevalence of spasticity post stroke. Clin Rehabil 2002; 16(5): 515–522. doi: 10.1191/ 0269215502cr512oa.

7. Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol 2008; 15(6): 533–539. doi: 10.1111/ j.1468-1331.2008.02114.x.

8. Opheim A, Danielsson A, Alt Murphy M et al. Upper-limb spasticity during the first year after stroke: stroke arm longitudinal study at the university of gothenburg. Am J Phys Med Rehabil 2014; 93(10): 884–896. doi: 10.1097/ PHM.0000000000000157.

9. Jech R, Klinické aspekty spasticity. Neurol praxi 2015; 16(1): 14–19.

10. Lapeyre E, Kuks JB, Meijler WJ. Spasticity: revisiting the role and the individual value of several pharmacological treatments. NeuroRehabilitation 2010; 27(2): 193–200. doi: 10.3233/ NRE-2010-0596.

11. Snow BJ, Tsuji JK, Bhart MH et al. Treatment of spasticity with botulinum toxin: a double-blind study. Ann Neurol 1990; 28(4): 512–515. doi: 10.1002/ ana.410280407.

12. Olvey EL, Armstrong EP, Grizzle AJ. Contemporary pharmacologic treatments for spasticity of the upper limb after stroke: a systematic review. Clin Ther 2010; 32(14): 2282–2303. doi: 10.1016/ j.clinthera.2011.01.005.

13. Rosales RL, Chua-Yap AS. Evidence-based systematic review on the effi cacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Transm (Vienna) 2008; 115(4): 617–623. doi: 10.1007/ s00702-007-0869-3.

14. Simon O, Yelnik AP. Managine spasticity with drugs. Eur J Phys Rehabil Med 2010; 46(3): 401–410.

15. Penn RD, Kroin JS. Intrathecal baclofen alleviates spinal cord spasticity. Lancet 1984; 1(8385): 1078. doi: 10.1016/ s0140-6736(84)91487-9.

16. Boviatis EJ, Kouyialis AT, Korfias S et al. Functional outcome of intrathecal baclofen administration for severe spasticity. Clin Neurol Neurosurg 2005; 107(4): 289–295. doi: 10.1016/ j.clineuro.2004.09.007.

17. Dario A, Scamoni C, Bono G et al. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol 2001; 16(4): 311–315.

18. Zahavi A, Geertzen JH, Staal M et al. Long term effect (more that five years) of Intrathecal baclofen on impaitrment, disability and quality of life in patients with severe spasticity of spinal origin. J Neurol Neurosurg Psychiatry 2004; 75(11): 1553–1557. doi: 10.1136/ jnnp.2003.014282.

19. Stetkarova I, Yablon SA, Kofl er M et al. Procedure and device-related complications of intrathecal baclofen administration for management of adult muscle hypertonia: a review. Neurorehabil Neural Repair 2010; 24(7): 609–619. doi: 10.1177/ 1545968310363585.

20. Štetkářová I. Léčba spasticity u dospelých. Med praxi 2012; 9(3): 124–126.

21. Houdek M, Kala M, Pavlíček V. Míšní spasticita – nové léčebné možnosti. Praktický lékař 1996; 76: 3110–3112.

22. Gregorová J, Holečková P. Intratekální podání léčiv u onkologického pacienta s refraktérní bolestí. Klin Farmakol Farm 2017; 31(3): 23–27.

23. Creamer M, Cloud G, Kossmehl P et al. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: result from a multicentre, randomised, controlled, open/ label trial (SISTERS). J Neurol Neurosurg Psychiatry 2018; 89(6): 642–650. doi: 10.1136/ jnnp-2017-317021.

24. Stayer C, Tronnier V, Dressnandt J et al. Intrathecal baclofen therapy for stiff-person syndrome and progressive encephalomyelopathy with rigidity and myoclonus. Neurology 1997; 49(6): 1591–1597. doi: 10.1212/ wnl.49.6.1591.

25. Marquardt G, Lorenz R. Intrathecal baclofen for intractable spasticity in amyotrophic lateral sclerosis. J Neurol 1999; 246(7): 619–620.

26. Štětkářová I, Ehler E, Jech R. Spasticita a její léčba. Praha: Maxdorf 2012: 117–128.

27. Heetla HW, Staal MJ, Kliphuis C et al. The incidence and management of tolerance in inrathecal baclofen therapy. Spinal Cord 2009; 47(10): 751–756. doi: 10.1038/ sc.2009.34.

28. Štětkářová I, Yablon SA, Kofler M et al. Procedure- and device- related complications of intrathecal baclofen administration for management of adult muscle hypertonia: a review. Neurorehabil Neural Repair 2010; 24(7): 609–619. doi: 10.1177/ 1545968310363585.

29. Avellino AM, Loeser JD. Intrathecal baclofen for the treatment of intractable spasticity of spine and brain etiology. Neuromodulation 2000; 3(2): 75–81. doi: 10.1046/ j.1525-1403.2000.00075.x.

30. Coffey JR, Cahill D, Steers W et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg 1993; 78(2): 226–232. doi: 10.3171/ jns.1993.78.2.0226.

31. Penn RD, Savoy SM, Corcos D et al. Intrathecal baklofen for severe spinal spasticity. New Engl J Med 1989; 320(23): 1517–1521. doi: 10.1056/ NEJM198906083202303.