Date Presented 4/16/2015
This report describes a randomized, double-blinded, placebo-controlled trial examining the efficacy of shoulder Botox® injections for reducing pain, impairment, and disability. Implications for occupational therapy practice are highlighted for best patient outcomes of the adult stroke survivor.
SIGNIFICANCE: In a recent study, Hansen et al. (2012) found that 45.8% of patients 6 mo poststroke reported newly developed pain with a moderate-to-severe impact on daily life in 33.6% of these cases. Significant differences in the Disability Assessment Scale (DAS) in those receiving Botox® injections of the wrist and fingers as compared to the control group have been found (Brashear et al., 2002).
INNOVATION: There is a paucity of evidence for the effectiveness of Botox injections in spasticity reduction or functional improvement in the shoulder of poststroke patients (Marciniak et al., 2012).
METHOD: What is the efficacy of onabotulinumtoxinA (BoT-A) injections to the shoulder in reducing pain, impairment, and disability in patients who have had a stroke? The hypothesis was that those in the BoT-A group would have lower pain levels and tone and secondary improvements in disability and mood. We used a prospective randomized, double-blinded, placebo-controlled trial that took place in a large metropolitan rehabilitation hospital and research center.
Adults (n = 37) with poststroke shoulder pain and spasticity provided ratings of 3 or 4 on the Modified Ashworth Scale (MAS). After screening for exclusion and inclusion criteria, 21 participants were randomized to receive BoT-A or placebo injections. Scores were assessed at 2, 4, and 12 wk after injection with (1) daily pain ratings using visual analog scales of best and worst pain and the DAS for dressing, hygiene, pain, and cosmesis; (2) the McGill Pain Questionnaire–Short Form; (3) the Fugl-Meyer Assessment; (4) the Beck Depression Inventory; (5) the FIM–Upper Body Dressing and Hygiene; (6) range of motion; and (7) the MAS. Analytical methods included a 2 × 4 mixed-model analysis of variance (ANOVA), an independent-samples t test for change scores, and a Mann–Whitney U test when statistical assumptions were not met.
RESULTS: BoT-A and placebo groups showed decreased pain scores at 4 wk (ps < .05), with no significant differences found between the groups for any of the daily pain ratings (ps > .05; Marciniak et al., 2012). Significant improvement (p < .05) in change scores for hygiene on the DAS was found in the BoT-A group compared with the placebo group at Week 4, and there was a similar trend toward significant improvement on the DAS Dressing scale (p = .061; Marciniak et al., 2012).
CONCLUSION: Pain reduction in the BoT-A group was not greater than in the placebo group, and these reductions did not correlate with mood improvements (Marciniak et al., 2012). The improvements on the DAS ratings of hygiene and dressing suggest that Botox could affect daily care in patients with shoulder pain in the adult stroke population (Marciniak et al., 2012). It is imperative that occupational therapists understand practice implications of Botox in stroke care to capitalize on possible performance gains for best patient outcomes. Limitations of the study include the following: Subjects were very impaired and thus less likely to improve, a true occupation-based evaluation was not used to show functional change, and a small sample size was used to determine change.
References
Brashear, A., Gordon, M. F., Elovic, E., Kassicieh, V. D., Marciniak, C., Do, M., . . . Turkel, C. (2002). Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. New England Journal of Medicine, 347, 395–400. http://dx.doi.org/10.1056/NEJMoa011892
Hansen, A. P., Marcussen, N. S., Klit, H., Andersen, G., Finnerup, N. B., & Jensen, T. S. (2012). Pain following stroke: A prospective study. European Journal of Pain, 16, 1128–1136. http://dx.doi.org/10.1002/j.1532-2149.2012.00123.x
Marciniak C. M., Harvey R. L., Gagnon C. M., Duraski S. A., Denby F. A., McCarty S., . . . Fierstein K. M. (2012). Does botulinum toxin Type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity? A randomized, double-blind, placebo-controlled trial. American Journal of Physical Medicine and Rehabilitation, 91, 1007–1019. http://dx.doi.org/10.1097/PHM.0b013e31826ecb02
