Residual Limb Hyperhidrosis and RimabotulinumtoxinB: A Randomized, Placebo-Controlled Study

Publication date: Available online 23 January 2016
Source:Archives of Physical Medicine and Rehabilitation
Author(s): Paul F. Pasquina, Briana N. Perry, Aimee L. Alphonso, Sacha Finn, Kevin F. Fitzpatrick, Jack W. Tsao
ObjectiveTo investigate the use of RimabotulinumtoxinB (BoNT-B, Myobloc) compared to placebo in treating hyperhidrosis in the residual limbs of individuals with amputation.DesignRandomized, double-blind, placebo-controlled pilot study.SettingThe study took place at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, M.D., a military medical center that provides both inpatient and outpatient services.ParticipantsNine male subjects with a total of eleven major amputations of the lower limbs and who complained of excessive sweating in their residual limbs were enrolled in the study from September 2010 to November 2012. Participants' lower limbs were randomly assigned to either receive injections of BoNT-B (n=7) or placebo (n=4).InterventionRimabotulinumtoxinB (BoNT-B, Myobloc).Main Outcome MeasuresThe primary efficacy variable was a minimum 50% reduction in sweat production 4 weeks after injection as measured by gravimetric assessment following 10 minutes of physical exertion. Secondary analyses were conducted on prosthetic function and pain.ResultsAll volunteers (100%) in the BoNT-B group achieved at least a 50% reduction in sweat, compared to only 50% of the placebo group. The percent reduction was significantly greater for the BoNT-B group compared to controls (-72.7±15.7% vs. -32.7±39.2%; p<0.05). Although both groups self-reported significant subjective sweat reduction and improved prosthetic functioning (both p<0.05), objective gravimetric sweat measurements significantly decreased only for the BoNT-B group (2.3±2.3 g vs. 0.7±1.1 g; p<0.05). Neither group reported a change in phantom limb pain (PLP) or residual limb pain (RLP) (both p>0.05).ConclusionBoNT-B successfully reduces sweat production in individuals with residual limb hyperhidrosis, but does not affect pain. There were no differences found between BoNT-B and placebo groups in perceived effect on prosthetic use.



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