A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A in the Treatment of Hemiplegic Shoulder Pain and Spasticity

Article Outline

• Disclosures
• Objective
• Design
• Setting
• Participants
• Interventions
• Main Outcome Measures
• Results
• Conclusions
• Copyright

Keywords: Stroke, Rehabilitation, Botulinum toxin type A, Shoulder pain

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Disclosures 

C. M. Marciniak, Allergan, Inc, Research grants; Allergan, Inc, Consulting fees or other remuneration.

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Objective 

To assess the efficacy of botulinum toxin type A injections into shoulder musculature for reducing pain, impairment, and disability in stroke patients with shoulder pain and spasticity.

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Design 

Randomized, double-blind, placebo-controlled trial.

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Setting 

Academic rehabilitation facility.

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Participants 

Adults (n = 19) with post-stroke shoulder spasticity and pain.

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Interventions 

Following baseline assessments, subjects were randomized to botulinum toxin type A (Botox^®), up to 200 units, into the pectoralis major with or without teres major injections, or intramuscular placebo (saline) injections.

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Main Outcome Measures 

Daily pain ratings using visual analogue scales of best and worst pain, and pain with dressing; Disability Assessment Scale (DAS) for Dressing, Hygiene, Pain and Cosmesis; McGill Pain Questionnaire-SF; Fugl-Meyer; and Modified Ashworth Scale scores at baseline, 2, 4, 12, and 16 weeks post-injection. Primary outcomes were assessed at week 4. A mixed-model ANOVA was used to evaluate BTX vs. saline injection effects on pain at weeks 1-4.

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Results 

Subject groups were well-matched at baseline, with no significant difference in demographic variables, worst pain ratings, or Fugl-Meyer scores. Both BTX and placebo groups showed decreased pain scores at 4 weeks (P = .001), with no significant differences between groups found for daily pain ratings of best/worst pain (P = .743). Follow-up contrasts showed significant reductions in pain ratings at weeks 1-4 compared to baseline. Statistically significant improvement (P < .05) in the DAS for both Hygiene and Dressing Scales were found in the BTX group compared to placebo at week 4, with a mean improvement change in score of -0.7 in the DAS for both Hygiene and Dressing in the BTX group, while those receiving placebo showed trend in rating toward greater disability (+.78 and +.44, respectively). The mean DAS Pain scale change improved for the BTX group (-0.9) but this did not significantly differ from those receiving saline (mean change 0.0).

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Conclusions 

BTX shoulder muscle injections in stroke patients with spasticity and shoulder pain significantly improved selected disability measures, but the observed pain reduction was not greater than that found for placebo.