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Intrathecal Baclofen Therapy for Adults with Spinal Spasticity: Therapeutic Efficacy and Effect on Hospital Admissions

Published online by Cambridge University Press:  18 September 2015

Patricia Nance ,
Orpha Schryvers ,
Brian Schmidt ,
Hy Dubo ,
Brenda Loveridge  and
Derek Fewer
Patricia Nance*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
Orpha Schryvers*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
Brian Schmidt*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
Hy Dubo*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
Brenda Loveridge*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
Derek Fewer*
Affiliation:
Department of Medicine (P.N., O.S., H.D., B.S.), Section of Physical Medicine and Rehabilitation (P.N., O.S.), Section of Neurology (B.S.), School of Medical Rehabilitation (B.L.), Department of Surgery, Section of Neurosurgery (D.F.), University of Manitoba, Winnipeg
*
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
Rehabilitation Hospital, 800 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1M4
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Abstract:

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A prospective trial to demonstrate the efficacy of intrathecal baclofen therapy by implanted pump for adults with spasticity due to spinal cord injury or multiple sclerosis was initiated in our hospital. Of the 140 patients assessed, 7 met the following criteria for inclusion in the study: a modified Ashworth score > 3, a spasm frequency score > 2, and an inadequate response to oral antispasticity drugs, (i.e., baclofen, clonidine and cyproheptadine). All patients responded to intrathecal bolus injection of baclofen in the double blind, placebo-controlled screening phase (mean bolus dose = 42.8 μg). Programmable Medtronic pumps were implanted in 4 patients while 3 patients received nonprogrammable Infusaid pumps. Post-implantation, a marked decrease in spasticity occurred with a significant reduction of the Ashworth score (mean = 1.8, p < .005), a reduced spasm score (mean = 0.8, p < .005), and an improved leg swing in the pendulum test. These effects were maintained during a follow-up of 24 – 41 months (average infusion dose = 218.7 μg/day). The gross cost-savings due to reduced hospitalizations related to spasticity was calculated by comparing the cost for the two year period before pump implantation to the same period after treatment for 6 of the 7 patients. The cost of in-hospital implantation as well as the cost of the pumps were deducted from the gross savings. There was a net cost-saving of $153,120. Our findings agree with the reported efficacy and safety of intrathecal baclofen treatment, and illustrate the cost-effectiveness of this treatment.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 22 , Issue 1 , February 1995 , pp. 22 - 29
Copyright
Copyright © Canadian Neurological Sciences Federation 1995

References

1. Bergamini, L, Riccio, A, Bergamasco, B.Un farmaco ad azione antispastica della muscalatura striata: sperimentazione clinica di un derivato del GABA. Minerva Med 1966; 57: 2733–2739.Google ScholarPubMed
2. Jerusalem, F.A double-blind study on the antispastic action of beta- (4-chlophenyl)-gamma-amino butyric acid (CIBA) in multiple sclerosis. Nervenarzt 1968; 39: 515.Google Scholar
3. Pedersen, E, Arlien-Soborg, P, Grynderup, V, Henriksen, O.GABA derivatives in spasticity. Acta Neurol Scand 1970; 46: 257–266.CrossRefGoogle ScholarPubMed
4. Jones, RF, Burke, D, Marosszeky, JE, Gilles, JD.A new agent for the control of spasticity. J Neurol Neurosurg Psychiatry 1970; 33: 464–468.CrossRefGoogle ScholarPubMed
5. Hudgson, P, Weightman, D.Baclofen in the treatment of spasticity. Br Med J 1971; 4: 15–17.CrossRefGoogle ScholarPubMed
6. Burke, D, Andrews, CJ, Knowles, L.The action of a GABA derivative in human spasticity. J Neurol Sci 1971; 14: 199–208.CrossRefGoogle ScholarPubMed
7. Shahani, BT, Young, RR.Management of flexor spasms with Lioresal. Arch Phys Med Rehabil 1974; 55: 465–467.Google ScholarPubMed
8. Duncan, GW, Shahani, BT, Young, RR.An evaluation of baclofen treatment for certain symptoms in patients with spinal cord lesions. Neurology 1976; 26: 441–446.CrossRefGoogle ScholarPubMed
9. McLellan, DL.Co-contraction and stretch reflexes in spasticity during treatment with baclofen. J Neurol Neurosurg Psychiatry 1977; 40:30–38.CrossRefGoogle Scholar
10. Hassan, N, McLellan, DL.Double-blind comparison of single doses of DS 103–282, baclofen and placebo for suppression of spasticity. J Neurol Neurosurg Psychiatry 1980; 43: 1132–1136.CrossRefGoogle ScholarPubMed
11. Knutsson, E, Lindblom, U, Martensson, A.Differences in effects in gamma and alpha spasticity induced by the GABA derivative baclofen (Lioresal). Brain 1973; 96: 29–46.CrossRefGoogle ScholarPubMed
12. McLellan, DL.Effect of baclofen upon monosynaptic and tonic vibratory reflexes in patients with spasticity. J Neurol Neurosurg Psychiatry 1973; 36: 555–560.CrossRefGoogle Scholar
13. Feldman, RG, Kelly-Hayes, M, Conomy, JP, Foley, JM.Baclofen for spasticity in multiple sclerosis: double-blind crossover and three-year study. Neurology 1978; 28: 1094–1098.CrossRefGoogle ScholarPubMed
14. From, A, Heltberg, A.Double-blind trial with baclofen (Lioresal) and diazepam in spasticity due to multiple sclerosis. Acta Neurol Scand 1975; 51: 158–166.CrossRefGoogle ScholarPubMed
15. Hattab, JR.Review of European clinical trials with baclofen. In: Feldman, RG, Young, RR, Koella, WP, eds. Spasticity: Disordered Motor Control. Chicago: Year Book, 1980: 71–85.Google Scholar
16. Dralle, D, Muller, H, Zierski, J, Klug, N.Intrathecal baclofen for spasticity. Lancet 1985; 2: 1003.Google ScholarPubMed
17. Hankey, GJ, Stewart-Wynne, EG, Perlman, D.Intrathecal baclofen for severe spasticity. Med J Aust 1986; 145: 465–466.CrossRefGoogle ScholarPubMed
18. Muller, H, Zierski, J, Dralle, D, Borner, U, Hoffman, O.The effect of intrathecal baclofen in spasticity. In: Muller, H, Zierski, J, Penn, RD, eds. Local Spinal Therapy of Spasticity. Berlin: Springer-Verlag, 1988: 155–214.Google Scholar
19. Penn, RD, Savoy, SM, Coreos, DC, Latash, M, Gottlieb, G, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med 1989; 320: 1517–1518.CrossRefGoogle ScholarPubMed
20. Lazorthes, Y, Sallerin-Caute, B, Verdie, J, Bastide, R, Carillo, J.Chronic intrathecal baclofen administration for control of severe spasticity. J Neurosurg 1990; 72: 393–402.CrossRefGoogle ScholarPubMed
21. Loubser, PG, Narayan, RK, Sandin, KJ, Donovan, WH, Russell, KD.Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury. Paraplegia 1991; 29: 48–64.Google ScholarPubMed
22. Meythaler, JM, Steers, WD, Tuel, SM, Cross, LL, Haworth, CS.Continuous intrathecal baclofen in spinal cord spasticity: a prospective study. Am J Phys Med Rehabil 1992; 71(6): 321–327.CrossRefGoogle ScholarPubMed
23. McLean, BN.Intrathecal baclofen in severe spasticity. Br J Hosp Med 1993; 49(4): 262–267.Google ScholarPubMed
24. Coffey, RJ, Cahill, D, Steers, W, Park, TS, Ordia, J, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicentre study. J Neurosurg 1993; 78: 226–232.CrossRefGoogle Scholar
25. Hugenholtz, H, Nelson, RF, Dehoux, E, Bickerton, R.Intrathecal baclofen for intractable spinal spasticity – a double-blind crossover comparison with placebo in 6 patients. Can J Neurol Sci 1992; 19: 188–195.CrossRefGoogle ScholarPubMed
26. Nance, PW, Schmidt, BJ, Dubo, HI, Hu, F, Fewer, D.Continuous intrathecal baclofen infusion for the treatment of adults with spinal spasticity. Can J Neurol Sci 1992; 19: 304.Google Scholar
27. Frankel, HL, Hancock, DO, Hyslop, G, Melzak, J, Michaelis, S, et al. The value of postural reduction in the initial management of closed injuries to the spine with paraplegia and tetraplegia. Paraplegia 1969; 7: 179–192.Google Scholar
28. Ashworth, B.Preliminary trial of carisoprodal in multiple sclerosis. Practitioner 1964; 192: 540–542.Google ScholarPubMed
29. Nance, PW, Halstead, LS, Seager, SWJ.Video motion analysis of knee swing in spastic spinal cord injured patients before and after perineal electrostimulation. Soc Neurosci Abstr 1992; 18: 1403.Google Scholar
30. Nance, PW.A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients. J Am Parapleg Soc 1994; 17: 151–157.CrossRefGoogle ScholarPubMed
31. Perkash, I.Management of neurogenic dysfunction of the bladder and bowel. In: Kottke, FJ, Stillwell, GK, Lehmann, JF, eds. Krusen’s Handbook of Physical Medicine and Rehabilitation, 3rd ed. Philadelphia: WB Saunders Co., 1982: 724–745.Google Scholar
32. Helmholtz, HF Jr, Stonnington, HH.Rehabilitation for respiratory dysfunction. In: Kottke, FJ, Stillwell, GK, Lehmann, JF, eds. Krusen’s Handbook of Physical Medicine and Rehabilitation, 3rd ed. Philadelphia: WB Saunders Co., 1982: 771–786.Google Scholar
33. Black, LF, Hyatt, RE.Maximal static respiratory pressure in generalized neuromuscular disease. Am Rev Respir Dis 1971; 103: 641–650.Google ScholarPubMed
34. Jamous, A, Bodiey, R.Isotope myelography in the assessment of patients with intrathecal pumps. Int Med Soc Paraplegia 1991; abstracts.Google Scholar
35. Medtronic SynchroMed drug administration system clinical study: summary of safety and effectiveness, pre-market approval application. Medtronic Inc.Google Scholar
36. Infusaid Drug Appendix for Model 400/600 implantable infusion pump for the treatment of spasticity. 1990; Infusaid, Inc.Google Scholar
37. Winer, BJ.Statistical Principles in Experimental Design, 2nd ed. New York: McGraw-Hill, 1971.Google Scholar
38. Nanninga, JB, Frost, F, Penn, R.Effect of intrathecal baclofen on bladder and sphincter function. J Urol 1989; 142: 101–105.CrossRefGoogle ScholarPubMed
39. Broseta, J, Garcia-March, G, Sánchez-Ledesma, MJ, Anaya, J, Silva, I.Chronic intrathecal baclofen administration in severe spasticity. Stereotact Funct Neurosurg 1990; 54+55: 147–153.CrossRefGoogle ScholarPubMed
40. Talalla, A, Grundy, D, Macdonell, R.The effect of intrathecal baclofen on the lower urinary tract in paraplegia. Paraplegia 1990; 28:420–427.Google ScholarPubMed
41. Parke, B, Penn, RD, Savoy, SM, Corços, D.Functional outcome after delivery of intrathecal baclofen. Arch Phys Med Rehabil 1989; 70: 30–32.CrossRefGoogle ScholarPubMed
42. Frost, F, Nanninga, J, Penn, R, Savoy, S, Wu, YIntrathecal baclofen infusion effect on bladder management programs in patients with myelopathy. Am J Phys Med Rehabil 1989; 68: 112–115.CrossRefGoogle ScholarPubMed
43. Steers, WD, Meythaler, JM, Haworth, C, Herrell, D, Park, TS.Effects of acute bolus and chronic continuous intrathecal baclofen on genitourinary dysfunction due to spinal cord pathology. J Urol 1992; 148: 1849–1855.CrossRefGoogle ScholarPubMed
44. Taveira da Silva, AM, Hartley, B, Hamosh, P, Quest, JA, Gillis, RA.Respiratory depressant effects of GABA alpha- and beta-receptor agonists in the cat. J Appl Physiol 1987; 62: 2264–2272.CrossRefGoogle ScholarPubMed
45. Romijn, JA, van Lieshout, JJ, Velis, DN.Reversible coma due to intrathecal baclofen. Lancet 1986: 696.CrossRefGoogle ScholarPubMed
46. Saltuari, L, Baumgartner, H, Kofler, M, Schmutzhard, E, Russegger, L, et al. Failure of physotigmine in treatment of acute severe intrathecal baclofen intoxication. N Engl J Med 1990; 322: 1533.Google Scholar
47. Brown, RA, Lawson, DA, Leslie, GC, Part, NJ.Observations on the applicability of the Wartenberg pendulum test to healthy, elderly subjects. J Neurol Neurosurg Psychiatry 1988: 51: 1171–1177.CrossRefGoogle ScholarPubMed