Abstract
Background
The purpose of this study was to investigate the epidemiological, humanistic, and economic burden of illness associated with adult lower limb spasticity (LLS) and its complications.
Methods
A systematic search of MEDLINE and EMBASE identified 23 studies published between January 2002 and October 2012 that assessed the epidemiology, impact, and resource use associated with LLS. A hand-search of four neurology conferences identified abstracts published between 2010 and 2012.
Results
LLS was found to occur in one third of adults after stroke, half to two thirds with multiple sclerosis, and three quarters with cerebral palsy. LLS limits mobility and reduces quality of life. No clear association was found between LLS and occurrence of pain, development of contractures, or risk of falls.
Conclusion
The evidence on the burden of LLS and its complications is surprisingly limited given the condition’s high prevalence among adults with common disorders, such as stroke. Further research is needed to clarify the impact of LLS, including the likelihood of thrombosis in spastic lower limbs. The dearth of high-quality evidence for LLS suggests a lack of awareness of, and interest in, the problem, and therefore, the unmet need among patients and their carers.
Supplementary materials
Search strategy
Database searches
Gray literature search
We searched the gray literature (material that can be referenced but is not published in peer-reviewed MEDLINE-indexed or EMBASE-indexed medical journals) for any information pertaining to epidemiologic, quality of life, and economic outcomes of the burden of LLS. We manually searched the following websites for articles relevant to LLS, using the same inclusion criteria as for the database searches:
World Federation for Neurorehabilitation (http://wfnr.co.uk)
World Stroke Congress (http://www1.kenes.com/wsc)
World Federation of Neurology (http://www.wfneurology.org)
American Neurological Association/Association of British Neurologists (http://www.aneuroa.org)
Inclusion and exclusion criteria
Inclusion criteria
Patient population
Patients older than 18 years of age with LLS, that could have resulted from any of the following underlying diseases:
○ Stroke
○ Multiple sclerosis
○ Traumatic brain injury
○ Cerebral palsy
○ Others, for example, Parkinson’s disease
Studies reporting follow-up from childhood to adulthood
Studies with more than 50% adult populations
Outcomes
Epidemiologic outcomes
○ Prevalence and incidence of LLS due to different underlying pathologies, as listed above under population
○ Trends of LLS over time
○ Outcomes and prognosis of LLS
○ Health and social problems associated with LLS
○ Comorbidities associated with LLS
○ Treatment patterns with botulinum toxin or other interventions in adults with LLS
Humanistic/quality of life outcomes
○ Utilities associated with LLS
○ Quality of life outcomes with LLS
○ Patient-reported outcomes
○ Patient satisfaction with treatment/care for LLS
○ Burden on carers of patients with LLS
○ Quality of life associated with efficacy/effectiveness of treatment for LLS
○ Access to care
○ Unmet needs
Economic outcomes
○ Direct costs of LLS (health and social care)
○ Indirect costs of LLS (eg, productivity, employment for patients and carers)
○ Resource use by patients with LLS and carers, including costs and resource use associated with treatments for LLS (pharmacological or non-pharmacological)
○ Burden on society from LLS
Year of publication
Studies published in the last 10 years (2002–2012)
Languages
Only publications in English were considered
Study design
Primary research including cohort studies, case-control studies, cross-sectional studies, case series, and randomized controlled trials (if available), and database studies
Exclusion criteria
Patient population
Studies investigating patients without LLS
Studies on adolescents and children younger than 18 years of age with LLS
Outcomes
Articles without relevant data on any of the outcomes of interest
Studies on genetic profiling
Prevalence studies with fewer than ten participants
Articles investigating the efficacy and/or effectiveness of botulinum toxin or any other investigation in the treatment of LLS
Studies investigating the biomechanical factors associated with spasticity (eg, electromyogram findings, joint angle, foot position, muscle blood flow)
Studies assessing the validity of instruments used to measure spasticity
Study design
Letters to the editor
Narrative reviews
Editorials
Expert opinions
Case studies
Articles were not excluded based on the geographic location. Systematic review articles published in the past four years (October 2008–October 2012) and meeting abstracts from the last two years or last two conference meetings were also included.
Abbreviation: LLS, lower limb spasticity.
Acknowledgments
The authors would like to acknowledge the following contributors to this article: Ike Iheanacho, who provided editorial input, and Louise Lombard, Amy McDonough, and Erica Zaiser, who contributed to data collection and analysis.
Disclosure
AM and SA are both employed by Evidera. HK and JD are employees of Ipsen. The authors report no other conflicts of interest in this work. Funding of this literature review was provided by Ipsen Pharma SAS.