with chronic pain conditions, and what is published is derived from studies involving pharmacologic and psychological interventions. We here calculate these values based on data collected from 144 participants of a previously published multicenter clinical trial investigating the effects of a single treatment with percutaneous cryoneurolysis. METHODS: In the original trial, we enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction. At both baseline and 4 months (primary end point), participants rated their phantom limb pain based on a numeric rating scale (NRS) and their interference of pain on physical and emotional functioning as measured with the Brief Pain Inventory’s interference subscale. They subsequently qualitatively defined the change using the 7-point ordinal Patient Global Impression of Change (PGIC). The smallest clinically meaningful improvements in phantom limb pain and Brief Pain Inventory scores were calculated using an anchor-based method based on the PGIC. RESULTS: The median (interquartile range [IQR]) phantom pain NRS (0–10) improvements at 4 months considered small, medium, and large were 1 [1–1], 3 [3–4], and 4 [3–6], respectively. The median improvements in the Brief Pain Inventory interference subscale (0–70) associated with a small, medium, and large analgesic changes were 16 [6–18], 24 [22–31], and 34 [22–46]. The proportions of patients that experienced PGIC ≥5 were 33% and 36% in the active and placebo groups, respectively. The relative risk of a patient experiencing PGIC ≥5 in the active group compared to the sham group with 95% confidence interval was 0.9 (0.6–1.4), P = .667. CONCLUSIONS: Amputees with phantom limb pain treated with percutaneous cryoneurolysis rate analgesic improvements as clinically meaningful similar to pharmacologic treatments, although their MCID for the Brief Pain Inventory was somewhat larger than previously published values. This information on patient-defined clinically meaningful improvements will facilitate interpretation of available studies and guide future trial design....

中文翻译：

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根据冷冻神经松解术后整体改善的患者报告定义的截肢相关疼痛和简要疼痛量表评分的最小临床意义改善：随机对照临床试验的回顾性分析


患有慢性疼痛疾病，发表的内容来自涉及药物和心理干预的研究。我们在这里根据从先前发表的一项多中心临床试验的 144 名参与者那里收集的数据计算这些值，该试验调查了经皮冷神经溶解症单一治疗的效果。方法： 在最初的试验中，我们招募了下肢截肢和已确定幻肢痛的患者。每个人都接受了利多卡因的单次股神经和坐骨神经阻滞，随后被随机分配在这些相同位置接受超声引导下经皮冷冻神经松解术或假治疗。研究人员、参与者和临床工作人员对治疗组分配不知情，但进行冷冻神经溶解的主治医师除外，他们随后没有参与者互动。在基线和 4 个月（主要终点）时，参与者根据数字评定量表 （NRS） 对他们的幻肢痛进行评分，并根据简要疼痛量表的干扰分量表测量疼痛对身体和情绪功能的干扰进行评分。随后，他们使用 7 点顺序患者总体印象变化 （PGIC） 定性地定义了变化。幻肢痛和简要疼痛量表评分的最小临床意义改善是使用基于 PGIC 的基于锚的方法计算的。结果： 4 个月时被认为较小、中等和较大的中位 （四分位间距 [IQR]）幻肢痛 NRS （0-10） 改善分别为 1 [1-1] 、 3 [3-4] 和 4 [3-6]。 与小、中、大镇痛变化相关的简要疼痛量表干扰分量表 （0-70） 的中位改善为 16 [6-18]、24 [22-31] 和 34 [22-46]。活性药物组和安慰剂组经历 PGIC ≥5 的患者比例分别为 33% 和 36%。与具有 95% 置信区间的假手术组相比，活性组患者发生 PGIC ≥5 的相对风险为 0.9 （0.6-1.4），P = .667。结论： 接受经皮冷冻神经溶解治疗的幻肢痛截肢者镇痛改善率与药物治疗相似，具有临床意义，尽管他们的简要疼痛量表的 MCID 略大于以前公布的值。这些关于患者定义的具有临床意义的改善的信息将有助于解释现有研究并指导未来的试验设计。