【疼痛专题】冷冻射频消融与标准医疗管理慢性骶髂关节疼痛：一项多中心、随机比较有效性研究

Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study

冷冻射频消融与标准医疗管理慢性骶髂关节疼痛：一项多中心、随机比较有效性研究

Introduction  

Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo- controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies.

腰痛是全世界残疾的主要原因，其中骶髂关节疼痛占轴性腰痛病例的30%。保守疗法只能提供适度的缓解。尽管安慰剂对照试验显示骶骨侧支冷却射频消融的疗效，但没有比较有效性的研究。

Methods  

In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short- term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1–S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0–10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. 

方法 在这项随机、多中心比较有效性研究中，210 名临床疑似骶髂关节疼痛的患者从诊断性骶髂关节注射和预后侧支阻滞中获得短期获益，被随机分配接受L5背支和S1–S3侧支冷却射频消融治疗，或由药物治疗、注射和综合治疗组成的标准医疗管理。主要结局指标是 3 个月时腰痛评分的平均降低（0-10 数字评分量表）。次要结果包括生活质量和功能的测量。

Results  

3 months post- treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001).52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL- 5 score 0.68±0.22 vs 0.47±0.29; p<0.0001).

治疗后 3 个月，冷却射频消融组的平均数字评定量表疼痛评分为 3.8±2.4（平均降低 2.5±2.5），而标准医疗管理组为 5.9±1.7（平均降低 0.4±1.7）。p<0.0001）。

冷却射频消融组中 52.3% 的受试者经历了 >2 分或 30% 的疼痛缓解，并被视为应答者，而标准医疗管理患者的这一比例为 4.3% (p<0.0001)。在 Oswestry 残疾指数评分（平均 29.7±15.2 vs 41.5+13.6；p<0.0001）和生活质量（平均 EuroQoL-5 评分 0.68±0.22 vs 0.47±0.29；p<0.0001）。

Conclusions  

In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management.

在骶髂关节疼痛患者中，与标准医疗管理相比，冷却射频消融在患者整个预后的各个方面提供了统计学上优越的改善。

重要结果展示：

Primary outcome measure and responder rates.

1.Baseline pain scores in both groups were in the moderate range (mean 6.3, SD 1.4 in both groups) (table 2). At 3 months, the mean NRS pain score for the CRFA group was 3.8±2.4 compared with 5.9±1.7 in the SMM group (p<0.0001). The mean reduction in average NRS pain score was 2.5±2.5 in the CRFA group (38.6% pain reduction from baseline) compared with a 0.4±1.7 reduction (4.9% from baseline) in the control group (p<0.0001). 

两组患者基线疼痛评分为中度(平均6.3，标准差均为1.4)。3 个月时，CRFA(冷却射频消融) 组的平均NRS评分为 3.8±2.4，而 SMM（标准医疗管理）组的平均 NRS 评分为 5.9±1.7（p<0.0001）。CRFA 组的平均 NRS 疼痛评分平均降低了 2.5±2.5（与基线相比疼痛降低了 38.6%），而对照组则降低了0.4±1.7（与基线相比疼痛降低4.9%）（p<0.0001）。

2. At 3 months, 52.3% of subjects in the CRFA group were deemed responders per protocol definition, compared with 4.3% in the SMM group (p<0.0001). In the CRFA group, 41.9% of subjects reported ≥50% reduction in NRS pain score, defined as 'substantial improvement’, compared with 6.5% in the SMM group (p<0.0001). The superiority of CRFA compared with SMM held true with sensitivity (eg, complete case) analyses. 

在3个月时，CRFA组中52.3%的受试者被认为是应答者，而SMM组为4.3% (p<0.0001)。在CRFA组中，41.9%的受试者报告NRS疼痛评分降低≥50%，定义为“实质性改善”，而SMM组为6.5% (p<0.0001)。与SMM相比，CRFA的优势在敏感性分析中也是如此

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Secondary outcome measures

1. At 3 months, the CRFA group had an SF-36 function score of 40.2±9.0 from a baseline of 33.6±7.8, representing a 6.5±9.2 point (24.5%) improvement. In comparison, the 3-month SF-36 score increased to 33.0±6.8 from a baseline of 32.3±6.4 in the SMM group, representing a 4.5% improvement (p<0.0001). 3个月时，CRFA组SF-36功能评分为40.2±9.0分，比基线33.6±7.8分提高6.5±9.2分(24.5%)。相比之下，SMM组3个月的SF-36评分从基线的32.3±6.4增加到33.0±6.8，改善了4.5% (p<0.0001)。

2.Overall ODI score for the CRFA group improved from a baseline of 40.7±13.8to 29.7±15.2 at 3 months, which was a significantly greater decrease compared with the control group (p<0.0001). Positive trends in individual ODI categories were seen across the CRFA cohort (figure 3). The percentage of patients with minimal disability increased from a baseline of 6.7% to 34.5% and the percentage of patients with severe disability decreased from a baseline of 39.0% to 24.1% at 3 months in the CRFA group. Similar trends were not observed in the SMM cohort. 

CRFA组的总ODI评分从基线40.7±13.8改善到3个月时的29.7±15.2，与对照组相比明显下降(p<0.0001)。在整个CRFA队列中，个体ODI类别呈积极趋势(图3) 在CRFA组中，轻度残疾患者的百分比从基线的6.7%增加到34.5%，严重残疾患者的百分比从基线的39.0%下降到24.1%。在SMM队列中没有观察到类似的趋势。

3.At 3 months, the CRFA cohort reported a mean increase in EQ-5D-5L of 0.19 points, exceeding the established minimal clinically important difference of 0.074 for an individual patient, versus a mean increase of 0.01 points in the SMM cohort. 在3个月时，CRFA队列报告的EQ-5D-5L平均增加0.19个点，超过了个体患者的最小临床重要差异0.074，而SMM队列的平均增加0.01个点

4. Results of linear regression demonstrated that receipt of CRFA treatment was a predictor of NRS reduction (estimate=2.058, SE=0.335, 95% CI 1.402 to 2.714, p<0.0001) as was age (for every 1-year increase in age, NRS was reduced by 0.026 points, SE=0.013, 95% CI 0.001 to 0.052, p=0.047) (online supplemental table 2). 线性回归结果显示，接受CRFA治疗是NRS降低的预测因子(估计值=2.058,SE=0.335, 95% CI 1.402至2.714,p<0.0001)和年龄(年龄每增加1年，NRS降低0.026点，SE=0.013, 95% CI 0.001至0.052,p=0.047).

5. There was a trend for a higher BMI to be associated with greater pain reduction (for every 1 kg/m2 increase in BMI, NRS was reduced by 0.056, SE=0.031, 95% CI −0.005 to 0.117, p=0.07) (table 3). Participants ≥65 years of age also responded more favorably to SMM. BMI越高，疼痛减轻的程度越高(BMI每增加1 kg/m2, NRS降低0.056,SE=0.031, 95% CI - 0.005至0.117,p=0.07)(表3)。年龄≥65岁的参与者对SMM的反应也更有利。

笔记差劲先森。

排版/叮当丸子麻

冷冻射频消融与标准医疗管理慢性骶髂关节疼痛：一项多中心、随机比较有效性研究(1).pdf