Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity
Michael Creamer, Geoffrey Cloud, Peter Kossmehl, Michael Yochelson, Gerard E Francisco, Anthony B Ward, Jörg Wissel, Mauro Zampolini, Abdallah Abouihia, Alessandra Calabrese, Leopold Saltuari, Michael Creamer, Geoffrey Cloud, Peter Kossmehl, Michael Yochelson, Gerard E Francisco, Anthony B Ward, Jörg Wissel, Mauro Zampolini, Abdallah Abouihia, Alessandra Calabrese, Leopold Saltuari
Abstract
Background and Purpose- Intrathecal baclofen (ITB) is an effective treatment for managing patients with severe poststroke spasticity, who can experience continued pain and decline in their quality of life (QoL). SISTERS (Spasticity In Stroke-Randomized Study) was a randomized, controlled, open-label, multicenter, phase 4 study to evaluate ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of poststroke spasticity. Methods- Poststroke patients with spasticity in ≥2 extremities and an Ashworth Scale score of ≥3 in ≥2 affected lower extremity muscle groups were randomized (1:1) to ITB (N=31) or CMM (N=29). Both treatment arms received physiotherapy throughout. The primary outcome was the change in average Ashworth Scale score in the lower extremities of the affected side from baseline to month 6. Here, we report results for secondary outcomes: pain via the Numeric Pain Rating Scale, health-related QoL by the EuroQol-5 dimensional 3 level utility score and health status visual analog scale score, stroke-specific QoL, and patient satisfaction. Analyses were performed on an intention-to-treat basis. Results- We observed significant treatment effects in favor of ITB over CMM for changes from baseline to month 6 in Numeric Pain Rating Scale scores for actual pain (ITB versus CMM: mean, -1.17 [SD, 3.17] versus 0.00 [3.29]; median, -1.00 versus 0.00; P=0.0380) and least pain (mean, -1.61 [2.29] versus 0.24 [3.07]; median, -1.00 versus 0.00; P=0.0136), and EuroQol-5 dimensional 3 level utility scores (mean, +0.09 [0.26] versus +0.01 [0.16]; median, +0.07 versus 0.00; P=0.0197). Between-group differences were not statistically significant for EuroQol-5 dimensional 3 level visual analog scale, stroke-specific QoL summary, or Numeric Pain Rating Scale worst pain scores, although ITB patients showed greater numeric improvements from baseline during follow-up. More ITB patients than CMM patients (73% versus 48%) were satisfied with the spasticity reduction at month 6. Conclusions- These data support that ITB therapy is associated with improvements in pain and QoL in poststroke patients. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01032239.
Keywords: baclofen; muscle spasticity; pain; quality of life; stroke.
Figures
References
- Treister AK, Hatch MN, Cramer SC, Chang EY. Demystifying poststroke pain: from etiology to treatment. PM R. 2017;9:63–75. doi: 10.1016/j.pmrj.2016.05.015.
- Opara JA, Jaracz K. Quality of life of post-stroke patients and their caregivers. J Med Life. 2010;3:216–220.
- Naess H, Lunde L, Brogger J. The effects of fatigue, pain, and depression on quality of life in ischemic stroke patients: the Bergen Stroke Study. Vasc Health Risk Manag. 2012;8:407–413. doi: 10.2147/VHRM.S32780.
- Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013;80(3)(suppl 2):S13–S19. doi: 10.1212/WNL.0b013e3182762448.
- Dvorak EM, Ketchum NC, McGuire JR. The underutilization of intrathecal baclofen in poststroke spasticity. Top Stroke Rehabil. 2011;18:195–202. doi: 10.1310/tsr1803-195.
- Wissel J, Schelosky LD, Scott J, Christe W, Faiss JH, Mueller J. Early development of spasticity following stroke: a prospective, observational trial. J Neurol. 2010;257:1067–1072. doi: 10.1007/s00415-010-5463-1.
- Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, et al. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015;13:159. doi: 10.1186/s12955-015-0340-3.
- Simpson DM, Gracies JM, Graham HK, Miyasaki JM, Naumann M, Russman B, et al. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. 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;70:1691–1698. doi: 10.1212/01.wnl.0000311391.00944.c4.
- Esquenazi A, Albanese A, Chancellor MB, Elovic E, Segal KR, Simpson DM, 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. doi: 10.1016/j.toxicon.2012.11.025.
- Taira T, Tanikawa T, Kawamura H, Iseki H, Takakura K. Spinal intrathecal baclofen suppresses central pain after a stroke. J Neurol Neurosurg Psychiatry. 1994;57:381–382.
- Schiess MC, Oh IJ, Stimming EF, Lucke J, Acosta F, Fisher S, et al. Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement. Neuromodulation. 2011;14:38–45. discussion 45. doi: 10.1111/j.1525-1403.2010.00308.x.
- Kofler M, Quirbach E, Schauer R, Singer M, Saltuari L. Limitations of intrathecal baclofen for spastic hemiparesis following stroke. Neurorehabil Neural Repair. 2009;23:26–31. doi: 10.1177/1545968308317700.
- Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87:1509–1515. doi: 10.1016/j.apmr.2006.08.323.
- Hoving MA, van Raak EP, Spincemaille GH, van Kranen-Mastenbroek VH, van Kleef M, Gorter JW, et al. Dutch Study Group on Child Spasticity. Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy. Eur J Paediatr Neurol. 2009;13:247–256. doi: 10.1016/j.ejpn.2008.05.002.
- Vles GF, Soudant DL, Hoving MA, Vermeulen RJ, Bonouvrié LA, van Oostenbrugge RJ, et al. Long-term follow-up on continuous intrathecal Baclofen therapy in non-ambulant children with intractable spastic Cerebral Palsy. Eur J Paediatr Neurol. 2013;17:639–644. doi: 10.1016/j.ejpn.2013.06.003.
- Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, et al. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997;63:204–209.
- Delhaas EM, Beersen N, Redekop WK, Klazinga NS. Long-term outcomes of continuous intrathecal baclofen infusion for treatment of spasticity: a prospective multicenter follow-up study. Neuromodulation. 2008;11:227–236. doi: 10.1111/j.1525-1403.2008.00170.x.
- Natale M, D’Oria S, Nero VV, Squillante E, Gentile M, Rotondo M. Long-term effects of intrathecal baclofen in multiple sclerosis. Clin Neurol Neurosurg. 2016;143:121–125. doi: 10.1016/j.clineuro.2016.02.016.
- Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, et al. 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;89:642–650. doi: 10.1136/jnnp-2017-317021.
- Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149–158.
- EuroQoL Group. Euroqol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
- Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999;30:1362–1369.
- Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35:1095–1108.
- Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ. 2010;340:c186.
- Wissel J, Ganapathy V, Ward AB, Borg J, Ertzgaard P, Herrmann C, et al. OnabotulinumtoxinA improves pain in patients with post-stroke spasticity: findings from a randomized, double-blind, placebo-controlled trial. J Pain Symptom Manage. 2016;52:17–26. doi: 10.1016/j.jpainsymman.2016.01.007.
- Doan QV, Brashear A, Gillard PJ, Varon SF, Vandenburgh AM, Turkel CC, et al. Relationship between disability and health-related quality of life and caregiver burden in patients with upper limb poststroke spasticity. PM R. 2012;4:4–10. doi: 10.1016/j.pmrj.2011.10.001.
Source: PubMed