Selective dorsal rhizotomy (SDR) is a neurosurgical procedure advocated for the relief of spasticity in cerebral palsy (CP). Despite a lack of critica studies to document the clinical effectiveness of SDR, the procedure is being adopted enthusiastically. No published studies take into account the effect of possible selection bias, expectation bias or cotreatment. All children who undergo SDR also receive intensive physical therapy. The opportunity for objective study will be lost once SDR becomes broadly accepted, we propose a prospective randomized clinical trial using objectiv outcome measures to investigate the effectiveness of SDR. The purpose of this proposed study is to evaluate the effectiveness of SDR in reducing spasticity and improving gross motor function of children with spastic diplegia, a common form of CP. Eighty children, 3 - 18 years, will be recruited and randomized into two groups. Group A will receive SDR and intensive physical therapy for six months. Group B will receive equivalent intensive physical therapy but not SDR. Outcomes will be assessed blindly at entry, 6, 12, and 24 months. Outcome variables are: 1) electromechanica measurement of joint torque for spasticity, and 2) a valid objective clinical evaluation of gross motor function. Primary emphasis will be on 2 month outcome. Subject entry will be complete after 24 months and the last data collection will occur at 48 months. Data analysis and presentation will require a fifth year.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS027867-03
Application #
3414282
Study Section
Neurology A Study Section (NEUA)
Project Start
1991-05-15
Project End
1996-03-31
Budget Start
1993-04-01
Budget End
1994-03-31
Support Year
3
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Seattle Children's Hospital
Department
Type
DUNS #
048682157
City
Seattle
State
WA
Country
United States
Zip Code
98105
McLaughlin, John F; Felix, Steven D; Nowbar, Sogol et al. (2005) Lower extremity sensory function in children with cerebral palsy. Pediatr Rehabil 8:45-52
McLaughlin, John; Bjornson, Kristie; Temkin, Nancy et al. (2002) Selective dorsal rhizotomy: meta-analysis of three randomized controlled trials. Dev Med Child Neurol 44:17-25
Graubert, C; Song, K M; McLaughlin, J F et al. (2000) Changes in gait at 1 year post-selective dorsal rhizotomy: results of a prospective randomized study. J Pediatr Orthop 20:496-500
Hays, R M; McLaughlin, J F; Bjornson, K F et al. (1998) Electrophysiological monitoring during selective dorsal rhizotomy, and spasticity and GMFM performance. Dev Med Child Neurol 40:233-8
McLaughlin, J F; Bjornson, K F; Astley, S J et al. (1998) Selective dorsal rhizotomy: efficacy and safety in an investigator-masked randomized clinical trial. Dev Med Child Neurol 40:220-32
Dudgeon, B J; Libby, A K; McLaughlin, J F et al. (1994) Prospective measurement of functional changes after selective dorsal rhizotomy. Arch Phys Med Rehabil 75:46-53
McLaughlin, J F; Bjornson, K F; Astley, S J et al. (1994) The role of selective dorsal rhizotomy in cerebral palsy: critical evaluation of a prospective clinical series. Dev Med Child Neurol 36:755-69
Geiduschek, J M; Haberkern, C M; McLaughlin, J F et al. (1994) Pain management for children following selective dorsal rhizotomy. Can J Anaesth 41:492-6