治疗慢性腰背痛的 A 型肉毒杆菌毒素:双盲随机对照研究

Mantu Jain, Shahnawaz Khan, Paulson Varghese, Sujit Kumar Tripathy, Manaswini Mangaraj
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引用次数: 0

摘要

背景:腰背痛(LBP)是骨科医生在门诊中经常处理的一个普遍问题。引起腰背痛的原因多种多样,其中脊柱旁肌肉僵硬是一个显著的诱因。研究发现,注射 A 型肉毒杆菌毒素(BoNT-A)可以通过放松这些僵硬的肌肉来缓解背痛。虽然 BoNT-A 已被批准用于多种疾病,但只有有限的随机临床试验(RCT)验证了它专门用于治疗腰背痛的疗效。目的:研究 BoNT-A 在减轻慢性腰背痛(CLBP)患者疼痛和改善其功能方面的安全性和疗效:在这项 RCT 研究中,研究人员招募了年龄在 18-60 岁之间、患有持续至少 6 个月的机械性枸杞痛的成年人。参与者被分配到药物组(接受 200 Ipsen 单位(2 mL)的 BoNT-A)或对照组(接受 2 mL 的安慰剂)。在为期 2 个月的随访期间,两组患者在研究开始和结束时均使用视觉模拟量表 (VAS) 评估疼痛强度,并使用 Oswestry 残疾指数 (ODI) 评估残疾程度。疼痛减轻 50% 即为具有临床意义:研究对 40 名患者进行了为期两个月的随访,每组 20 人。在 36 名参与者中观察到疼痛明显减轻。在两个月结束时,各组的 VAS 和 ODI 评分均有统计学意义上的显著下降。然而,在比较平均分数变化时,只有 ODI 分数的降低(安慰剂组为 15 分,药物组为 16.5 分,临床意义不大)具有统计学意义(P = 0.012),而 VAS 平均分数的变化则不显著(P = 0.45):研究结论:与安慰剂相比,BoNT-A 无法在短期内减轻慢性阻塞性肺病患者的疼痛或改善其 LBP 评分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Botulinum toxin type A for treating chronic low back pain: A double blinded randomized control study.

Background: 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.

Aim: To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP (CLBP).

Methods: 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.

Results: 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 vs 16.5 in the drug group, clinically insignificant) was statistically significant (P = 0.012), whereas the change in mean VAS scores was not significant (P = 0.45).

Conclusion: 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.

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