SELECTIVE DORSAL RHIZOTOMY - EFFICACY AND SAFETY IN AN INVESTIGATOR-MASKED RANDOMIZED CLINICAL-TRIAL

The objective of this single-center investigator-masked randomized cli nical trial was to investigate the efficacy and safety of selective do rsal rhizotomy (SDR) in children with spastic diplegia. Forty-three ch ildren with spastic diplegia were randomly assigned on an intention-to -treat basis to receive SDR plus physical therapy (PT), or PT alone. T hirty-eight children completed follow-up through 24 months. Twenty-one children received SDR (SDR+PT group) and lr received PT (PT Only grou p). SDR was guided with electrophysiological monitoring and performed by one experienced neurosurgeon. All subjects received equivalent PT. Spasticity was quantified with an electromechanical torque measurement device (spasticity measurement system [SMS]). The Gross Motor Functio n Measure (GMFM) was used to document changes in functional mobility. Primary outcome measures were collected at baseline, 6, 12, and 24 mon ths by evaluators masked to treatment. At 24 months, the SDR+PT group exceeded the PT Only group in mean reduction of spasticity by SMS meas urement (-8.2 versus +5.1 newton meters/radian, P=0.02). The SDR+PT gr oup and the PT Only group demonstrated similar improvements in indepen dent mobility on the GMFM: (7.0 versus 7.2 total percent score, P=0.94 ). Outcomes on secondary variables were consistent with primary outcom es. There were no serious adverse events. We conclude that SDR is safe and reduces spasticity in children with spastic diplegia. SDR plus PT and equivalent PT without SDR result in equal improvements in indepen dent mobility at a4 months. SDR may not be an efficacious treatment fo r children with mild spastic diplegia.