Do randomised controlled trials evaluating functional outcomes following botulinum neurotoxin-A align with focal spasticity guidelines? A systematic review.

PURPOSE: The impact of botulinum neurotoxin-A (BoNT-A) on functional outcomes when managing focal muscle spasticity remains unclear. It is possible that randomised controlled trial (RCT) design and/or reporting may be a contributing factor. The objective of this review was to determine the extent to which RCTs evaluating functional outcomes following BoNT-A align with focal spasticity guidelines. MATERIALS AND METHODS: RCTs published from 2010 were included if they targeted focal spasticity, included BoNT-A, randomised a physical intervention to the upper/lower limb, or the primary outcome(s) related to the activity/participation domains of the International Classification of Functioning, Disability, and Health. Data extraction and quality appraisal using the Modified PEDro and Modified McMasters Tool were performed independently by two reviewers. General research practices were also extracted such as compliance with therapy reporting guidelines. RESULTS: Fifty-two RCTs were eligible. Individualised goal setting was uncommon (25%). Six studies (11.5%) included multi-disciplinary management, and five (9.6%) included patient/caregiver education. Four studies (7.7%) measured outcomes beyond 6 months. The Median Modified PEDro score was 11/15. CONCLUSIONS: Alignment with focal spasticity guidelines in RCTs was generally low. Our understanding of the impact of focal spasticity management on functional outcomes may be improved if RCT design aligned more closely with guideline recommendations.IMPLICATIONS FOR REHABILITATIONThe influence of BoNT-A on improved functional outcomes is yet to be determined.Individualised goal setting with a multi-disciplinary team is uncommon in an RCT design, despite it being a key guideline recommendation.Given the long-term nature of spasticity management, guidelines recommend short as well as long-term reviews following intervention however RCTs rarely assess beyond 6 months.

A synthesis and appraisal of clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of focal spasticity in adults and children.

OBJECTIVE: To identify and appraise the existing clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of adult and paediatric focal spasticity to generate a single synthesized guideline. METHODS: Systematic review of 12 electronic databases. Clinical practice guidelines, consensus statements and Cochrane systematic reviews for focal spasticity in adults and children. Included studies were appraised according to the AGREE II criteria. RESULTS: A total of 25 papers were included in this review, comprising 12 clinical practice guidelines, nine consensus statements and four Cochrane systematic reviews. The areas most strongly endorsed were: (1) management to be provided by a multi-disciplinary team, (2) therapy should be goal-directed, (3) goals to be developed in conjunction with the patient and family, and (4) importance of follow-up evaluations. There was a greater focus on activity outcomes and classification in the paediatric papers. The guidelines varied considerably in their quality, with AGREE II scores ranging from 52.8 to 97.1%. CONCLUSIONS: This systematic review has synthesized the key elements regarding principles of focal spasticity management, outcome measures, physical interventions and educational recommendations into a single, readily applied guideline available for clinical use. Despite considerable variability in the quality of the guidelines, several strong themes emerged.Implications for rehabilitationFocal spasticity management should be multi-disciplinary, patient-centred and goal-directed.Routine measurement of impairment and activity are strongly endorsed.Botulinum toxin A injection should only be provided as part of an integrated approach to focal spasticity management.