Comparing the effects of two spasticity management strategies on the long-term outcomes of individuals with bilateral spastic cerebral palsy: a multicentre cohort study protocol

Meghan E Munger, Brian Po-Jung Chen, Bruce A MacWilliams, Mark L McMulkin, Michael H Schwartz, Meghan E Munger, Brian Po-Jung Chen, Bruce A MacWilliams, Mark L McMulkin, Michael H Schwartz

Abstract

Introduction: Spasticity is one of the primary pathologies associated with cerebral palsy (CP), yet no definitive evidence exists to guide the appropriate level of spasticity management for an individual. Spasticity management strategies often differ by center. On one end of this strategy spectrum is a highly-interventional approach, characterized by treatments such as a selective dorsal rhizotomy (SDR), intrathecal baclofen pump (ITB), and anti-spasticity injections and medications. On the other end of the spectrum is a less interventional approach, involving minimal use of these treatments, and no SDR.

Methods and analysis: A retrospectively-matched, multi-center study protocol is described that comprehensively compares the long-term outcomes of a highly-interventional versus a minimally-interventional spasticity management strategy. We will analyze two groups of adults with spastic bilateral CP (≥21 years). In one group are individuals who underwent an SDR between the ages of 4 and 10 years, along with ongoing spasticity management during childhood and adolescence. In the other group are individuals who received minimal spasticity management and did not undergo an SDR. Individuals with prolonged use of an intrathecal baclofen (ITB) pump will be excluded. The two groups will be matched for spasticity and other important clinical characteristics at baseline. This study design improves on many of the limitations found in the existing outcome literature.

Ethics and dissemination: This study received necessary approval from the University of Minnesota and Western Institutional Review Boards. Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number: NCT03789786.

Keywords: cerebral palsy; outcomes; selective dorsal rhizotomy; spasticity management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Distribution for overall spasticity of patients with cerebral palsy who had gait analysis in each centre. GIL, Gillette Children’s Specialty Healthcare; SLC, Shriners Hospitals for Children in Salt Lake City; SPK, Shriners Hospitals for Children in Spokane.
Figure 2
Figure 2
The selection process sites will follow in order to identify potential participants in the Yes-SDR and No-SDR groups. This sampling procedure should lead to matched groups at baseline. GIL, Gillette Children’s Specialty Healthcare; SDR, selective dorsal rhizotomy; SLC, Shriners Hospitals for Children in Salt Lake City; SPK, Shriners Hospitals for Children in Spokane.

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