Department of Rehabilitation Sciences, KU Leuven-University of Leuven, Leuven, Belgium; Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium.
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.
Arch Phys Med Rehabil. 2018 Jul;99(7):1342-1351. doi: 10.1016/j.apmr.2017.12.032. Epub 2018 Jan 31.
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.
Double-blinded (patient and assessor) randomized controlled trial.
A university hospital.
Breast cancer patients (N=50) with pain.
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.
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.
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).
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.
研究在标准物理治疗方案的基础上，于胸大肌内单次注射肉毒毒素 A（BTX-A）对乳腺癌幸存者持续性上肢疼痛的治疗效果。
双盲（患者和评估者）随机对照试验。
一所大学医院。
有疼痛的乳腺癌患者（N=50）。
干预组接受单次 BTX-A 浸润治疗，对照组接受安慰剂（盐水）浸润。浸润后 1 周内，所有患者均接受个体物理治疗方案（12 次），在前 3 个月内进行，以及浸润后 6 个月内的家庭运动方案。
主要结局是 3 个月后上肢疼痛强度的变化（视觉模拟评分，0-100）。次要结局是疼痛、压痛过敏、疼痛质量、肩部功能和生活质量的患病率。在干预前以及 1、3 和 6 个月随访时进行测量。
3 个月时疼痛强度的变化无显著差异（变化的平均差异，3/100；95%置信区间[CI]，-13 至 19）。从基线到 6 个月，干预组上肢疼痛强度的变化明显优于对照组（变化的平均差异，16/100；95%CI，1-31）。
单次 BTX-A 浸润联合个体物理治疗方案可显著降低乳腺癌幸存者上肢疼痛强度，长达 6 个月。然而，其效应大小并无临床意义，且未发现其他有益效果。
