An interview based approach to the anorectal portion of the International Standards of Neurological Classification of Spinal Cord Injury Exam (I-A-ISNCSCI): a pilot study.

STUDY DESIGN: Prospective, single-blinded study. OBJECTIVE: To design and evaluate the use of an interview based version of the anorectal portion of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam in the acute inpatient rehabilitation (AIR) setting. SETTING: AIR unit. METHODS: Participants admitted to AIR underwent standard ISNCSCI exams (S-ISNCSCI) as part of routine inpatient care within 3 days of being administered an interview version of the anorectal portion of the ISNCSCI (I-A-ISNCSCI). Agreement between the anorectal portion of the S-ISNCSCI (S-A-ISNCSCI) and the I-A-ISNCSCI was evaluated. RESULTS: Forty of forty-five enrolled participants completed the assessments. Agreement between the I-A-ISNCSCI and S-A-ISNCSCI was substantial for anorectal sensation to light touch (k = 0.71, 95% CI 0.52-0.90, N = 36), pin prick (k = 0.68, 95% CI 0.48-0.87, N = 38), deep anal pressure (k = 0.77, 95% CI 0.53-1.00, N = 37), and completeness of injury based on combined sacral sensory criteria (k = 0.72, 95% CI 0.47-0.97, N = 40); and fair for voluntary anal contraction (k = 0.29, 95% CI -0.01 to 0.59, N = 36). Responses of "I don't know" were excluded from agreement analyses. CONCLUSIONS: This pilot study was a first step in developing interview based tools such as the I-A-ISNCSCI in an AIR setting providing convenient access to individuals with SCI and their direct feedback. The study design introduces potential recall bias and may not match true clinical situations such as remote follow-up of neurological changes for chronic patients. The use of interview based tools for assessing individuals with SCI remains worthy of further study.

Treatment of at-level spinal cord injury pain with botulinum toxin A.

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 post-placebo (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).