Jain Mantu, Khan Shahnawaz, Varghese Paulson, Tripathy Sujit Kumar, Mangaraj Manaswini
Department of Orthopaedics, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India.
Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India.
World J Methodol. 2024 Sep 20;14(3):93854. doi: 10.5662/wjm.v14.i3.93854.
Low back pain (LBP) is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting. LBP can arise from various causes, with stiffness in the paraspinal muscles being a notable contributor. The administration of Botulinum toxin type A (BoNT-A) has been found to alleviate back pain by relaxing these stiff muscles. While BoNT-A is approved for use in numerous conditions, a limited number of randomized clinical trials (RCTs) validate its efficacy specifically for treating LBP.
To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP (CLBP).
In this RCT, adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled. Participants were allocated to either the Drug group, receiving 200 Ipsen Units (2 mL) of BoNT-A, or the Control group, which received a 2 mL placebo. Over a 2-month follow-up period, both groups were assessed using the Visual Analog Scale (VAS) for pain intensity and the Oswestry Disability Index (ODI) for disability at the start and conclusion of the study. A decrease in pain by 50% was deemed clinically significant.
The study followed 40 patients for two months, with 20 in each group. A clinically significant reduction in pain was observed in 36 participants. There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months. Nonetheless, when comparing the mean score changes, only the reduction in ODI scores (15 in the placebo group 16.5 in the drug group, clinically insignificant) was statistically significant ( = 0.012), whereas the change in mean VAS scores was not significant ( = 0.45).
The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients.
腰痛（LBP）是一个普遍存在的问题，骨科医生在门诊环境中经常会遇到。腰痛可能由多种原因引起，椎旁肌僵硬是一个显著因素。已发现注射A型肉毒杆菌毒素（BoNT-A）可通过放松这些僵硬的肌肉来缓解背痛。虽然BoNT-A被批准用于多种病症，但仅有少数随机临床试验（RCT）证实其对治疗腰痛的有效性。
研究BoNT-A在减轻慢性腰痛（CLBP）患者疼痛及改善功能结局方面的安全性和有效性。
在这项RCT中，纳入了年龄在18至60岁、机械性腰痛持续至少六个月的成年人。参与者被分配到药物组，接受200国际单位（2毫升）的BoNT-A，或对照组，接受2毫升安慰剂。在为期2个月的随访期内，在研究开始和结束时，使用视觉模拟量表（VAS）评估疼痛强度，使用奥斯威斯利功能障碍指数（ODI）评估功能障碍。疼痛减轻50%被认为具有临床意义。
该研究对40名患者进行了为期两个月的随访，每组20人。36名参与者的疼痛出现了具有临床意义的减轻。两个月结束时，两组的VAS和ODI评分均有统计学意义的下降。然而，比较平均评分变化时，只有ODI评分的下降具有统计学意义（安慰剂组从15降至16.5，药物组从15降至16.5，无临床意义）（P = 0.012），而平均VAS评分的变化不显著（P = 0.45）。
该研究得出结论，在减轻CLBP患者疼痛或改善腰痛评分方面，BoNT-A在短期内并不比安慰剂更具优势。
