Publication date: Available online 31 January 2018
Source:Archives of Physical Medicine and Rehabilitation
Author(s): An De Groef, Nele Devoogdt, Marijke Van Kampen, Ines Nevelsteen, Ann Smeets, Patrick Neven, Inge Geraerts, Lore Dams, Elien Van der Gucht, Philippe Debeer
ObjectiveTo investigate the effect of a single Botulinum Toxin A infiltration in the pectoralis major muscle in addition to a standard physical therapy program for treatment of persistent upper limb pain in breast cancer survivors.DesignDouble-blinded (patient and assessor) randomized controlled trialSettingUniversity Hospital Leuven, BelgiumParticipantsFifty breast cancer patients with pain.InterventionThe intervention group received a single Botulinum Toxin A (BTX-A) infiltration. The control group received a placebo (saline) infiltration. Within one week after the infiltration, all patients attended an individual physical therapy program (12 sessions) during the first 3 months and a home exercise program up to 6 months after infiltration.Main outcome MeasuresThe primary outcome was change in pain intensity at the upper limb (Visual Analogue Scale (VAS) (0-100)) after 3 months. Secondary outcomes were prevalence rate of pain, pressure hypersensitivity, pain quality, shoulder function and quality of life. Measures were taken before the intervention and at 1, 3 and 6 months follow-up.ResultsNo significant difference in change in pain intensity after 3 months was found (mean difference in change of 3/100; 95% CI -13 to 19). From baseline up to 6 months, a significantly different change in upper limb pain intensity was found between groups in favor of the intervention group (mean difference in change of 16/100; 95% CI 1 to 31).ConclusionA single Botulinum Toxin A infiltration in combination with an individual physical therapy program has been found to significantly decrease pain intensity at the upper limb in breast cancer survivors up to 6 months. However, the effect size was not clinically relevant and no other beneficial effects were found.
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