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A 28-Day Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Trial of Botulinum Toxin Type A for Raynaud's Phenomen
Kelli N. Webb, MD1; Nada N. Berry1, Reuben A. Bueno1; Carisa M. Cooney2; Jennifer L. Koechle1; Michael W. Neumeister1
1Division of Plastic and Reconstructive Surgery, Southern Illinois University School of Medicine, Springfield, IL; 2Plastic and Reconstructive Surgery, Johns Hopkins Hospital, Baltimore, MD

Background: Raynaudís phenomenon affects an estimated 28 million Americans and is a common cause of ischemic digits, severe pain, and nonhealing ulcers. Current treatment options can be ineffective, invasive, addictive, or have systemic side effects. Botulinum toxin type A (Btx-A) may be a novel therapeutic treatment option.

Methods: A prospective, randomized, placebo-controlled clinical trial was designed to describe the efficacy of injected Btx-A in alleviating pain due to Raynaudís disease. Our secondary goal was to describe this minimally invasive therapyís effects and impact on quality-of-life by measuring subjective pain scores, pain-free intervals, ulcer healing, changes in hand function, finger survival, and subsequent treatment choices. Study participants were randomized to receive injection with either placebo (normal saline) or 100 units of Btx-A into the palm around involved digital neurovascular bundles. Data collection included subjective evaluation of pain relief, serial photography of wound healing, and objective data on tissue perfusion using a Doppler perfusion imager and Periscan image analysis software.

Results: Currently, a total of 35 patients are actively participating in the study, which represents 88% of our total enrollment target (n=40). Twenty primary Raynaud's patients and fifteen secondary Raynaud's patients are enrolled. Seventeen of these subjects received placebo at the first study visit, and eighteen received the study agent, BOTOXģ. At presentation, twenty-three patients reported pain as their primary complaint. At one month, one out of ten (10%) placebo patients compared with eight out of thirteen (62%) Btx-A patients reported pain relief (p=.0288). At the follow-up visit on day 28, the patients were unblinded and placebo patients were offered injection with Btx-A. We completed a follow-up retrospective survey, with average follow-up of 239 days. 22 of 35 patients (63%) report symptom relief after injection with Btx-A. Average duration of symptom relief is 127 days. 6 of 10 patients (60%) with fingertip ulceration healed after Btx-A injection.

Conclusions: Btx-A injection may be an effective, localized, nonsurgical treatment option without addictive properties or systemic side effects for treatment of ischemic digits. Preliminary results show a statistically significant number of Raynaudís patients injected with Btx-A report pain relief compared with placebo at 1 month follow-up and 60% of patients with fingertip ulcerations healed their wounds. The second part of this study is to follow these patients for 5 years to determine the long-term efficacy of Btx-A injection for Raynaudís Phenomenon.


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