A review of the effects of baclofen and of THC:CBD oromucosal spray on spasticity-related walking impairment in multiple sclerosis

References

• Frohman EM, Racke MK, Raine CS. Multiple sclerosis—the plaque and its pathogenesis. N Engl J Med. 2006;354(9):942–9+55.
   PubMed Web of Science ®Google Scholar
• Kister I, Bacon TE, Chamot E, et al. Natural history of multiple sclerosis symptoms. Int J MS Care. 2013;15(3):146–158.
   PubMedGoogle Scholar
• Bensmail D, Vermersch P. Epidemiology and clinical assessment of spasticity in multiple sclerosis [Article in French]. Rev Neurol (Paris). 2012;168(Suppl 3):S45–S50.
   PubMedGoogle Scholar
• Bethoux F, Marrie RA. A cross-sectional study of the impact of spasticity on daily activities in multiple sclerosis. Patient. 2016;9(6):537–546.
   PubMedGoogle Scholar
• Pandyan AD, Gregoric M, Barnes MP, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005;27(1–2):2–6.
   PubMed Web of Science ®Google Scholar
• Mukherjee A, Chakravarty A. Spasticity mechanisms - for the clinician. Front Neurol. 2010;17(1):149.
   Google Scholar
• Bartels MN, Duffy CA, Beland HE. Management, and acute rehabilitation of stroke survivors. In: Gillen G, editor. Stroke rehabilitation: a function-based approach. 4th ed. St Louis (MO): Elsevier; 2016. p. 2–45.
   Google Scholar
• Hemmett L, Holmes J, Barnes M, et al. What drives quality of life in multiple sclerosis? QJM. 2004;97(10):671–676.
   PubMed Web of Science ®Google Scholar
• Ashworth B. Preliminary trial of carisoprodal in multiple sclerosis. Practitioner. 1964;192:540–542.
   PubMedGoogle Scholar
• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987;67(2):206–207.
   PubMed Web of Science ®Google Scholar
• Pandyan AD, Johnson GR, Price CI, et al. A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity. Clin Rehabil. 1999;13(5):373–383.
   PubMed Web of Science ®Google Scholar
• Fleuren JF, Voerman GE, Erren-Wolters CV, et al. Stop using the Ashworth Scale for the assessment of spasticity. J Neurol Neurosurg Psychiatry. 2010;81(1):46–52.
   PubMed Web of Science ®Google Scholar
• Farrar JT, Troxel AB, Stott C, et al. Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther. 2008;30(5):974–985.
   PubMed Web of Science ®Google Scholar
• Voerman GE, Fleuren JF, Kallenberg LA, et al. Patient ratings of spasticity during daily activities are only marginally associated with long-term surface electromyography. J Neurol Neurosurg Psychiatry. 2009;80(2):175–181.
   PubMed Web of Science ®Google Scholar
• Lance J. Symposium synopsis. In: Feldman R, Young R, Koella W, editors. Spasticity disordered motor control. Chicago: Year Book Medical Publishers; 1980. p. 485–494.
   Google Scholar
• Haugh AB, Pandyan AD, Johnson GR. A systematic review of the Tardieu Scale for the measurement of spasticity. Disabil Rehabil. 2006;28(15):899–907.
   PubMed Web of Science ®Google Scholar
• Phadke CP, Ismail F, Boulias C. Current challenges to clinical assessment of spasticity. Int J Neurol Res. 2015;1(1):1–4.
   Google Scholar
• Centonze D, Mori F, Koch G, et al. Lack of effect of cannabis-based treatment on clinical and laboratory measures in multiple sclerosis. Neurol Sci. 2009;30(6):531–534.
   PubMed Web of Science ®Google Scholar
• Leocani L, Nuara A, Houdayer E, et al. Sativex(®) and clinical-neurophysiological measures of spasticity in progressive multiple sclerosis. J Neurol. 2015;262(11):2520–2527.
   PubMed Web of Science ®Google Scholar
• Marinelli L, Mori L, Canneva S, et al. The effect of cannabinoids on the stretch reflex in multiple sclerosis spasticity. Int Clin Psychopharmacol. 2016;31(4):232–239.
   PubMed Web of Science ®Google Scholar
• Hobart JC, Riazi A, Thompson AJ,et al. Getting the measure of spasticity in multiple sclerosis: the Multiple Sclerosis Spasticity Scale (MSSS-88). Brain. 2006;129(Pt 1):224–234.
   PubMedGoogle Scholar
• Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013;123(12):850–858.
   PubMed Web of Science ®Google Scholar
• Flachenecker P, Henze T, Zettl UK. Spasticity in patients with multiple sclerosis–clinical characteristics, treatment and quality of life. Acta Neurol Scand. 2014;129(3):154–162.
   PubMed Web of Science ®Google Scholar
• Milinis K, Tennant A, Young CA, et al. Spasticity in multiple sclerosis: associations with impairments and overall quality of life. Mult Scler Relat Disord. 2016;5:34–39.
   PubMed Web of Science ®Google Scholar
• Oreja-Guevara C, González-Segura D, Vila C. Spasticity in multiple sclerosis: results of a patient survey. Int J Neurosci. 2013;123(6):400–408.
   PubMed Web of Science ®Google Scholar
• Svensson J, Borg S, Nilsson P. Costs and quality of life in multiple sclerosis patients with spasticity. Acta Neurol Scand. 2014;129(1):13–20.
   PubMed Web of Science ®Google Scholar
• Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40): iii, ix-x, 1–111.
   Google Scholar
• Pozzilli C. Advances in the management of multiple sclerosis spasticity: experiences from recent studies and everyday clinical practice. Expert Rev Neurother. 2013;13(12 Suppl):49–54.
   PubMed Web of Science ®Google Scholar
• Vermersch P. MObility ImproVEment with spasticity in multiple sclerosis in Europe: the MOVE 1 EU study. Neurodegener Dis Manag. 2014;4(6):407–415.
   PubMedGoogle Scholar
• de Sa JC, Airas L, Bartholome E, et al. Symptomatic therapy in multiple sclerosis: a review for a multimodal approach in clinical practice. Ther Adv Neurol Disord. 2011;4(3):139–168.
   PubMedGoogle Scholar
• National Institute for Health and Care Excellence (NICE). Multiple sclerosis in adults: management. NICE Clinical guideline 186. 2014 [cited 2018 Feb 12]. Available from: https://www.nice.org.uk/guidance/cg186
   Google Scholar
• Otero-Romero S, Sastre-Garriga J, Comi G, et al. Pharmacological management of spasticity in multiple sclerosis: systematic review and consensus paper. Mult Scler. 2016;22(11):1386–1396.
   PubMed Web of Science ®Google Scholar
• Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008;14(3):383–390.
   PubMed Web of Science ®Google Scholar
• Schwid SR, Goodman AD, Mattson DH, et al. The measurement of ambulatory impairment in multiple sclerosis. Neurology. 1997;49(5):1419–1424.
   PubMed Web of Science ®Google Scholar
• Fischer JS, Rudick RA, Cutter GR, et al. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS society clinical outcomes assessment task force. Mult Scler. 1999;5(4):244–250.
   PubMed Web of Science ®Google Scholar
• Motl RW, Cohen JA, Benedict R, et al. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017;23(5):704–710.
   PubMed Web of Science ®Google Scholar
• Paltamaa J, Sarasoja T, Leskinen E, et al. Measures of physical functioning predict self-reported performance in self-care, mobility, and domestic life in ambulatory persons with multiple sclerosis. Arch Phys Med Rehabil. 2007;88(12):1649–1657.
   PubMed Web of Science ®Google Scholar
• Hobart JC, Riazi A, Lamping DL, et al. Measuring the impact of MS on walking ability: the 12-item MS Walking Scale (MSWS-12). Neurology. 2003;60(1):31–36.
   PubMed Web of Science ®Google Scholar
• Balantrapu S, Sosnoff JJ, Pula JH, et al. Leg spasticity and ambulation in multiple sclerosis. Mult Scler Int. 2014;2014:649390.
   PubMedGoogle Scholar
• Grobelny A, Behrens JR, Mertens S, et al. Maximum walking speed in multiple sclerosis assessed with visual perceptive computing. PLoS One. 2017;12(12):e0189281.
   PubMed Web of Science ®Google Scholar
• Pau M, Coghe G, Atzeni C, et al. Novel characterization of gait impairments in people with multiple sclerosis by means of the gait profile score. J Neurol Sci. 2014;345(1–2):159–163.
   PubMed Web of Science ®Google Scholar
• Pau M, Coghe G, Corona F, et al. Effect of spasticity on kinematics of gait and muscular activation in people with multiple sclerosis. J Neurol Sci. 2015;358(1–2):339–344.
   PubMed Web of Science ®Google Scholar
• Baker R, McGinley JL, Schwartz MH, et al. The gait profile score and movement analysis profile. Gait Posture. 2009;30(3):265–269.
   PubMed Web of Science ®Google Scholar
• Zwibel HL. Contribution of impaired mobility and general symptoms to the burden of multiple sclerosis. Adv Ther. 2009;26(12):1043–1057.
   PubMed Web of Science ®Google Scholar
• Sutliff MH. Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin. 2010;26:109–119.
   PubMed Web of Science ®Google Scholar
• Pike J, Jones E, Rajagopalan K, et al. Social and economic burden of walking and mobility problems in multiple sclerosis. BMC Neurol. 2012;12:94.
   PubMed Web of Science ®Google Scholar
• Julian LJ, Vella L, Vollmer T, et al. Employment in multiple sclerosis. Exiting and re-entering the work force. J Neurol. 2008;255:1354–1360.
   PubMed Web of Science ®Google Scholar
• Salter AR, Cutter GR, Tyry T, et al. Impact of loss of mobility on instrumental activities of daily living and socioeconomic status in patients with MS. Curr Med Res Opin. 2010;26:493–500.
   PubMed Web of Science ®Google Scholar
• Simmons RD, Tribe KL, McDonald EA. Living with multiple sclerosis: longitudinal changes in employment and the importance of symptom management. J Neurol. 2010;257:926–936.
   PubMed Web of Science ®Google Scholar
• Kobelt G, Thompson A, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017;23(8):1123–1136.
   PubMed Web of Science ®Google Scholar
• Heesen C, Böhm J, Reich C, et al. Patient perception of bodily functions in multiple sclerosis: gait and visual function are the most valuable. Mult Scler. 2008;14:988–991.
   PubMed Web of Science ®Google Scholar
• Green R, Cutter G, Friendly M, et al. Which symptoms contribute the most to patients’ perception of health in multiple sclerosis? Mult Scler J Exp Transl Clin. 2017;3(3):2055217317728301.
   Google Scholar
• Hudgson P, Weightman D. Baclofen in the treatment of spasticity. BMJ. 1971;4(5778):15–17.
   PubMed Web of Science ®Google Scholar
• Nielsen JF, Anderson JB, Sinkjaer T. Baclofen increases the soleus stretch reflex threshold in the early swing phase during walking in spastic multiple sclerosis patients. Mult Scler. 2000;6(2):105–114.
   PubMedGoogle Scholar
• Orsnes GB, Sørensen PS, Larsen TK, et al. Effect of baclofen on gait in spastic MS patients. Acta Neurol Scand. 2000;101(4):244–248.
   PubMed Web of Science ®Google Scholar
• Lee BS, Jones J, Lang M, et al. Early outcomes after intrathecal baclofen therapy in ambulatory patients with multiple sclerosis. J Neurosurg. 2017 Dec 1:1-7. [Epub ahead of print].
   Google Scholar
• Wade DT, Makela P, Robson P, et al. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult Scler. 2004;10(4):434–441.
   PubMed Web of Science ®Google Scholar
• Collin C, Ehler E, Waberzinek G, et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res. 2010;32(5):451–459.
   PubMed Web of Science ®Google Scholar
• Novotna A, Mares J, Ratcliffe S, et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®)), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol. 2011;18(9):1122–1131.
   PubMed Web of Science ®Google Scholar
• Notcutt WG. A questionnaire survey of patients and carers of patients prescribed Sativex as an unlicensed medicine. Prim Health Care Res Dev. 2013;14(2):192–199.
   PubMed Web of Science ®Google Scholar
• Coghe G, Pau M, Corona F, et al. Walking improvements with nabiximols in patients with multiple sclerosis. J Neurol. 2015;262(11):2472–2477.
   PubMed Web of Science ®Google Scholar
• Cameron MH, Wagner JM. Gait abnormalities in multiple sclerosis: pathogenesis, evaluation, and advances in treatment. Curr Neurol Neurosci Rep. 2011;11(5):507–515.
   PubMed Web of Science ®Google Scholar
• Bethoux F. Gait disorders in multiple sclerosis. Continuum (Minneap Minn). 2013;19(4 Multiple Sclerosis):1007–1022.
   PubMedGoogle Scholar
• emc [Internet]. Fampyra 10 mg prolonged-release tablets. Summary of Product Characteristics. 2011 [cited 2018 Feb 14]. Available from: https://www.medicines.org.uk/emc/product/4763
   Google Scholar
• Blight AR. Treatment of walking impairment in multiple sclerosis with dalfampridine. Ther Adv Neurol Disord. 2011;4(2):99–109.
   PubMedGoogle Scholar
• Sahraian MA, Maghzi AH, Etemadifar M, et al. Dalfampridine: review of its efficacy in improving gait in patients with multiple sclerosis. J Cent Nerv Syst Dis. 2011;3:87–93.
   PubMedGoogle Scholar
• Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009;373(9665):732–738.
   PubMed Web of Science ®Google Scholar
• Goodman AD, Brown TR, Edwards KR, et al. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010;68(4):494–502.
   PubMed Web of Science ®Google Scholar
• Hoogstraten MC, van der Ploeg RJ, vd Burg W, et al. Tizanidine versus baclofen in the treatment of spasticity in multiple sclerosis patients. Acta Neurol Scand. 1988;77(3):224–230.
   PubMed Web of Science ®Google Scholar
• Calabrò RS, Cacciola A, Bertè F, et al. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016;37(4):503–514.
   PubMed Web of Science ®Google Scholar
• Calabrò RS, Russo M, Naro A, et al. Robotic gait training in multiple sclerosis rehabilitation: can virtual reality make the difference? Findings from a randomized controlled trial. J Neurol Sci. 2017;377:25–30.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. The role of SAtivex® associated with Robotic-Rehabilitation in improving the motor performances of multiple sclerosis patients (SARR). [cited 2018 July 24]. Available from: https://clinicaltrials.gov/ct2/show/NCT03186664
   Google Scholar
• Russo M, Dattola V, Logiudice AL, et al. The role of Sativex in robotic rehabilitation in individuals with multiple sclerosis: rationale, study design, and methodology. Medicine (Baltimore). 2017;96(46):e8826.
   PubMed Web of Science ®Google Scholar
• Baker D, Pryce G, Visintin C, et al. Big conductance calcium-activated potassium channel openers control spasticity without sedation. Br J Pharmacol. 2017;174(16):2662–2681.
   PubMed Web of Science ®Google Scholar