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Effectiveness of Botulinum Toxin A for Persistent Upper Limb Pain After Breast Cancer Treatment: A Double-Blinded Randomized Controlled Trial

  • An De Groef
    Correspondence
    Corresponding author An De Groef, PhD, Physical Therapist, University of Leuven, Department of Rehabilitation Sciences, O&N 4 Herestraat 49 – bus 1510, 3000 Leuven.
    Affiliations
    Department of Rehabilitation Sciences, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium
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  • Nele Devoogdt
    Affiliations
    Department of Rehabilitation Sciences, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium

    Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium
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  • Marijke Van Kampen
    Affiliations
    Department of Rehabilitation Sciences, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium
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  • Ines Nevelsteen
    Affiliations
    Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium

    Department of Surgical Oncology, KU Leuven–University of Leuven, Leuven, Belgium
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  • Ann Smeets
    Affiliations
    Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium

    Department of Surgical Oncology, KU Leuven–University of Leuven, Leuven, Belgium
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  • Patrick Neven
    Affiliations
    Department of Surgical Oncology, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium
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  • Inge Geraerts
    Affiliations
    Department of Rehabilitation Sciences, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium
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  • Lore Dams
    Affiliations
    Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
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  • Elien Van der Gucht
    Affiliations
    Department of Rehabilitation Sciences, KU Leuven–University of Leuven, Leuven, Belgium

    Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium
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  • Philippe Debeer
    Affiliations
    Department of Development and Regeneration, University Hospitals Leuven, Orthopaedics, Leuven, Belgium

    Institute for Orthopaedic Research and Training, KU Leuven–University of Leuven, Leuven, Belgium
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Published:February 03, 2018DOI:https://doi.org/10.1016/j.apmr.2017.12.032

      Abstract

      Objective

      To investigate the effect of a single botulinum toxin A (BTX-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.

      Design

      Double-blinded (patient and assessor) randomized controlled trial.

      Setting

      A university hospital.

      Participants

      Breast cancer patients (N=50) with pain.

      Intervention

      The intervention group received a single BTX-A infiltration. The control group received a placebo (saline) infiltration. Within 1 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 Measures

      The primary outcome was change in pain intensity at the upper limb (visual analog scale, 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.

      Results

      No significant difference in change in pain intensity after 3 months was found (mean difference in change, 3/100; 95% confidence interval [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, 16/100; 95% CI, 1–31).

      Conclusions

      A single BTX-A infiltration in combination with an individual physical therapy program significantly decreased 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.

      Keywords

      List of abbreviations:

      BTX-A (botulinum toxin A), CI (confidence interval), VAS (visual analog scale)
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