Safety and Potential Efficacy of Selective Dorsal Rhizotomy in Adults with Spinal Cord Injury-Induced Spasticity: An Open-Label, Non-Randomized, Single-Arm Trial.

BACKGROUND:Despite the abundant literature on the use of selective dorsal rhizotomy (SDR) in spastic cerebral palsy, no investigation has evaluated its use in adult patients with chronic spinal cord injury (SCI)-induced spasticity. The present investigation aimed to evaluate the safety and potential efficacy of SDR in chronic SCI-induced spasticity for the first time. METHODS:In this open-label, single-arm, non-randomized clinical trial, all patients were assigned to the single study intervention arm and underwent SDR. The primary outcome measure was the safety profile of SDR. Secondary outcome measures were Modified Ashworth Scale, Penn Spasm Frequency Scale, visual analog scale for spasticity, Spinal Cord Injury Spasticity Tool, Spinal Cord Independence measure version III, and Short Form 36 Health Survey Questionnaire. RESULTS:Six patients with cervical SCI and 4 with thoracic SCI were allocated to the single study intervention arm. No adverse event attributable to the SDR was found. Moreover, all secondary outcome measures of the study improved significantly over the study period (P < 0.001). Multiple regression analysis also found a significant association between level of injury and changes in average Modified Ashworth Scale scores (P = 0.041), Spinal Cord Injury Spasticity Tool score (P = 0.013), and Spinal Cord Independence measure version III total (P = 0.002) and mobility domain scores (P = 0.004) at 12-month postoperatively. CONCLUSIONS:This clinical trial indicated that SDR is a safe and potentially effective procedure in patients with severe and intractable SCI-induced spasticity. However, future clinical trials with larger sample sizes and adequate power are required to validate our findings regarding efficacy.