Effect of intrathecal baclofen on pain and quality of life in poststroke spasticity: A Randomized Trial (SISTERS)

Stroke

Volumn 49, Issue 9, 2018, Pages 2129-2137

  Creamer, Michael ^a   Cloud, Geoffrey ^b,c   Kossmehl, Peter ^d   Yochelson, Michael ^e,f   Francisco, Gerard E ^g   Ward, Anthony B ^h   Wissel, Jörg ⁱ   Zampolini, Mauro ^j   Abouihia, Abdallah ^k   Calabrese, Alessandra ^k   Saltuari, Leopold ^l,m  

^a Central Florida Pain Relief Centers   (United States)

^b ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^c Alfred Health ^*  (Australia)

^d Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik   (Germany)

^e NATIONAL REHABILITATION HOSPITAL   (United States)

^f SHEPHERD CENTER   (United States)

^g UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^h HAYWOOD HOSPITAL   (United Kingdom)

ⁱ Vivantes Klinikum Spandau   (Germany)

^j Ospedale di Foligno   (Italy)

^k Medtronic International Trading Sarl   (Switzerland)

^l Abteilung für Neurologie Landeskrankenhaus Hochzirl   (Austria)

^m Research Unit for Neurorehabilitation South Tyrol   (Italy)

more..

Author keywords

Baclofen; Muscle spasticity; Pain; Quality of life; Stroke

Indexed keywords

BACLOFEN; BENZODIAZEPINE DERIVATIVE; CENTRAL MUSCLE RELAXANT; CLONIDINE; DANTROLENE; TIZANIDINE;

ADULT; ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DRUG EFFECT; EUROPEAN QUALITY OF LIFE 5 DIMENSIONS 3 LEVEL QUESTIONNAIRE; EUROPEAN QUALITY OF LIFE 5 DIMENSIONS QUESTIONNAIRE; FEMALE; FOLLOW UP; HEALTH STATUS; HUMAN; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUMERIC RATING SCALE; OPEN STUDY; PAIN; PATIENT SATISFACTION; PATIENT-REPORTED OUTCOME; PHYSIOTHERAPY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SPASTICITY; STROKE PATIENT; VISUAL ANALOG SCALE; AGED; CLINICAL TRIAL; COMPLICATION; INTRASPINAL DRUG ADMINISTRATION; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PAIN MEASUREMENT; PHASE 4 CLINICAL TRIAL; SEVERITY OF ILLNESS INDEX; STROKE REHABILITATION; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; BACLOFEN; BENZODIAZEPINES; CLONIDINE; DANTROLENE; FEMALE; HUMANS; INFUSIONS, SPINAL; MALE; MIDDLE AGED; MUSCLE RELAXANTS, CENTRAL; MUSCLE SPASTICITY; PAIN; PAIN MEASUREMENT; PATIENT SATISFACTION; PHYSICAL THERAPY MODALITIES; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; STROKE; STROKE REHABILITATION; TREATMENT OUTCOME;

EID: 85055600823     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.118.022255     Document Type: Article

References (26)

1. 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
2. Opara JA, Jaracz K. Quality of life of post-stroke patients and their caregivers. J Med Life. 2010;3:216-220.
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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 evidencebased 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
9. 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
10. 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.
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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.
17. 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
18. Natale M, D'Oria S, Nero VV, Squillante E, Gentile M, Rotondo M. Longterm effects of intrathecal baclofen in multiple sclerosis. Clin Neurol Neurosurg. 2016;143:121-125. doi: 10.1016/j.clineuro.2016.02.016
19. 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
20. 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.
21. 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
22. Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999;30:1362-1369.
23. Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35:1095-1108.
24. 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.
25. Wissel J, Ganapathy V, Ward AB, Borg J, Ertzgaard P, Herrmann C, et al. OnabotulinumtoxinA improves pain in patients with poststroke 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
26. 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