Study design Randomized, double-blinded, placebo-controlled, cross-over study. Objective To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain. Setting Outpatient SCI clinic, New York, USA. Methods Participants were randomized to receive subcutaneous injections of either placebo or BoNTA with follow-up (office visit, telephone, or e-mail) at 2, 4, 8, and 12 weeks to assess the magnitude of pain relief post injection. Crossover of participants was then performed. Those who received placebo received BoNTA, and vice versa, with follow-up at 2, 4, 8, and 12 weeks. Results Eight participants completed at least one of the two crossover study arms. Four completed both arms. The median age of the eight participants was 45 years (range 32-61 years) and 75% were male. All had traumatic, T1-L3 level, complete SCI. Although our data did not meet statistical significance, we noted a higher proportion of participants reporting a marked change in average pain intensity from baseline to 8 and 12 weeks post-BoNTA vs. post-placebo (33% vs. 0%). At 2 and 4 weeks post-BoNTA, almost all participants reported some degree of reduced pain, while the same was not seen postplacebo (83% vs. 0%). Conclusion The subcutaneous injection of BoNTA may be a feasible approach for the control of at-level SCI pain and is worthy of further study. Sponsorship The onabotulinumtoxinA (BOTOX) used in this study was provided by Allergan (Irvine, CA).
Background A surgical procedure is a complex behavior that can be constructed from foundation or component behaviors. Both the component and the composite behaviors built from them are much more likely to recur if it they are reinforced (operant learning). Behaviors in humans have been successfully reinforced using the acoustic stimulus from a mechanical clicker, where the clicker serves as a conditioned reinforcer that communicates in a way that is language-and judgment-free; however, to our knowledge, the use of operant-learning principles has not been formally evaluated for acquisition of surgical skills. Questions/purposes Two surgical tasks were taught and compared using two teaching strategies: (1) an operant learning methodology using a conditioned, acoustic reinforcer (a clicker) for positive reinforcement; and (2) a more classical approach using demonstration alone. Our goal was to determine whether a group that is taught a surgical skill using an operant learning procedure would more precisely perform that skill than a group that is taught by demonstration alone. Methods Two specific behaviors, ''tying the locking, sliding knot'' and ''making a low-angle drill hole,'' were taught to the 2014 Postgraduate Year (PGY)-1 class and first-and second-year medical students, using an operant learning procedure incorporating precise scripts along with acoustic feedback. The control groups, composed of PGY-1 and -2 nonorthopaedic surgical residents and first-and second-year medical students, were taught using demonstration alone. The precision and speed of each behavior was recorded for each individual by a single experienced surgeon, skilled in operant learning. The groups were then compared. Results The operant learning group achieved better precision tying the locking, sliding knot than did the control group. Twelve of the 12 test group learners tied the knot and precisely performed all six component steps, whereas only four of the 12 control group learners tied the knot and correctly performed all six component steps (the test group median was 10 [range, 10-10], the control group median was 0 [range, 0-10], p = 0.004). However, the median ''time to tie the first knot'' for the test group was longer than for the control group (test group median 271 seconds [range, 184-626 Conclusions Operant learning occurs as the behavior is constructed and is highly reinforced with the result measured, not in the time saved, but in the ultimate outcome of an accurately built complex behavior. Level of Evidence Level II, therapeutic study.
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