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Selective dorsal rhizotomy: efficacy and safety in an investigator-masked randomized clinical trial
J F McLaughlin1, K F Bjornson, S J Astley
1Pediatrics, University of Washington, Seattle, USA. jfmcl@u.washington.edu
Insights
Selective dorsal rhizotomy (SDR) safely reduces spasticity in children with spastic diplegia. However, SDR plus physical therapy (PT) showed no greater improvement in mobility than PT alone at 24 months.
Area of Science:
- Neurology
- Pediatric Orthopedics
- Neurosurgery
Background:
- Spastic diplegia is a common form of cerebral palsy, characterized by increased muscle tone and stiffness in the legs.
- Selective dorsal rhizotomy (SDR) is a surgical procedure aimed at reducing spasticity.
- The efficacy of SDR in improving functional mobility in children with spastic diplegia requires further investigation.
Purpose of the Study:
- To investigate the efficacy and safety of selective dorsal rhizotomy (SDR) combined with physical therapy (PT) compared to PT alone in children with spastic diplegia.
- To assess the impact of SDR on spasticity and functional mobility over a 24-month period.
Main Methods:
- A single-center, investigator-masked, randomized clinical trial involving 43 children with spastic diplegia.
- Participants were randomly assigned to either SDR plus PT or PT alone.
- Spasticity was measured using a spasticity measurement system (SMS), and functional mobility was assessed with the Gross Motor Function Measure (GMFM).
Main Results:
- The SDR plus PT group showed a significantly greater reduction in spasticity compared to the PT alone group at 24 months (P=0.02).
- Both groups demonstrated similar improvements in independent mobility as measured by the GMFM (P=0.94).
- No serious adverse events were reported in either group.
Conclusions:
- Selective dorsal rhizotomy (SDR) is a safe procedure that effectively reduces spasticity in children with spastic diplegia.
- While SDR reduces spasticity, it does not lead to greater improvements in independent mobility compared to physical therapy alone at 24 months.
- SDR may not be an efficacious treatment for children with mild spastic diplegia.
Abstract:
The objective of this single-center investigator-masked randomized clinical trial was to investigate the efficacy and safety of selective dorsal rhizotomy (SDR) in children with spastic diplegia. Forty-three children with spastic diplegia were randomly assigned on an intention-to-treat basis to receive SDR plus physical therapy (PT), or PT alone. Thirty-eight children completed follow-up through 24 months. Twenty-one children received SDR (SDR+PT group) and 17 received PT (PT Only group). 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 Function Measure (GMFM) was used to document changes in functional mobility. Primary outcome measures were collected at baseline, 6, 12, and 24 months by evaluators masked to treatment. At 24 months, the SDR+PT group exceeded the PT Only group in mean reduction of spasticity by SMS measurement (-8.2 versus +5.1 newton meters/radian, P=0.02). The SDR+PT group and the PT Only group demonstrated similar improvements in independent mobility on the GMFM (7.0 versus 7.2 total percent score, P=0.94). Outcomes on secondary variables were consistent with primary outcomes. 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 independent mobility at 24 months. SDR may not be an efficacious treatment for children with mild spastic diplegia.