An De Groef1, Nele Devoogdt2, Marijke Van Kampen3, Ines Nevelsteen4, Ann Smeets4, Patrick Neven5, Inge Geraerts3, Lore Dams6, Elien Van der Gucht3, Philippe Debeer7. 1. Department of Rehabilitation Sciences, KU Leuven-University of Leuven, Leuven, Belgium; Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium. Electronic address: an.degroef@kuleuven.be. 2. 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. 3. Department of Rehabilitation Sciences, KU Leuven-University of Leuven, Leuven, Belgium; Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium. 4. Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium; Department of Surgical Oncology, KU Leuven-University of Leuven, Leuven, Belgium. 5. Department of Surgical Oncology, KU Leuven-University of Leuven, Leuven, Belgium; Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium. 6. Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. 7. Department of Development and Regeneration, University Hospitals Leuven, Orthopaedics, Leuven, Belgium; Institute for Orthopaedic Research and Training, KU Leuven-University of Leuven, Leuven, Belgium.
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.
RCT Entities:
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 cancerpatients (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.