【疼痛专题】膝神经冷却与传统射频治疗慢性膝关节疼痛的比较：一项多中心非劣性随机试验

Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non- inferiority randomized pilot trial

膝神经冷却与传统射频治疗慢性膝关节疼痛的比较：一项多中心非劣性随机试验

Background：Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking.

背景：

膝神经的射频 (RF) 治疗有可能减轻由于骨关节炎或持续性术后疼痛引起的慢性膝关节疼痛，但是，缺乏对所使用的两种主要方式（传统方式和冷却方式）的直接比较。

Methods ：This double blind, non- inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with ≥50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention.Conventional RF treatment was tested for non- inferiority to cooled in reducing knee pain at 3 months follow- up.

方法：

这项双盲、非劣效性、试点、随机对照试验比较了冷却和传统射频对患有骨关节炎或全膝关节置换术后持续性术后疼痛的慢性膝关节疼痛患者的影响。患者按照 1:1 的比例随机分配。主要结果是干预后 3 个月疼痛减轻 ≥ 50% 的患者比例。其他结果是膝关节疼痛、功能、生活质量、情绪健康和干预后长达 6 个月的不良事件。在 3 个月的随访中，测试了传统射频治疗在减轻膝关节疼痛方面的非劣效性。

Results ：Forty- nine of 70 patients were included, of which 47 completed a 3- month follow- up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non- inferiority comparison were inconclusive in relation to the non- inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events.

结果 ：

70 名患者中有 49 名被纳入，其中 47 名完成了 3 个月的随访。23 名接受常规 RF 治疗的患者中有 4 名 (17%) 与接受冷疗的 24 名患者中有 8 名 (33%) 实现了主要结果 (p=0,21)。非劣效性比较的结果在非劣效性界值方面没有定论。次要结果之间没有统计学上的显着差异。没有严重的不良事件。

Conclusions ：Both conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing ≥50% pain reduction between techniques. The non- inferiority analysis was inconclusive. These results warrant further research.

结论：

常规和冷却射频治疗均可减轻骨关节炎和持续性术后疼痛人群的疼痛。这项试点研究并未证明两种技术之间疼痛减轻 ≥ 50% 的患者比例存在统计学上的显着差异。非劣性分析是不确定的。这些结果值得进一步研究。

部分结果

1. The primary outcome

There were more patients who achieved the primary endpoint after a cooled RF in comparison with conventional RF as described in table 2. Similarly , a higher percentage of patients reached ≥50% pain reduction after a cooled RF in comparison with conventional RF at all other time points. However, these differences were not statistically significant at each time point. 

如表 2 中所述，与常规射频相比，冷却射频后有更多患者达到主要终点。同样，与所有其他时间的常规射频相比，冷却射频后达到≥50% 疼痛减轻的患者百分比更高点。然而，这些差异在每个时间点都没有统计学意义。

The differences between the proportion of patients with ≥50% pain reduction after an RF treatment (conventional and cooled combined) between OA and PPSP were also not statistically significant at each time point, although absolute numbers where at each time point higher in the OA group. 

OA 和 PPSP之间的射频治疗（常规和冷却组合）后疼痛减轻≥50% 的患者比例之间的差异在每个时间点也没有统计学意义，尽管 OA 组在每个时间点的绝对数字更高.

2.Secondary outcomes

Numerical Rating Scale At each time point, the mean NRS score of the OA subgroup, PPSP subgroup and the whole population decreased in astatistically significant manner (p<0.05) compared with baseline after both conventional and cooled RF treatment (figure 2). 

数值评定量表 在常规和冷却 RF 治疗后，每个时间点，OA 亚组、PPSP 亚组和整个人群的平均 NRS 评分呈递减趋势与基线相比具有统计学意义 (p<0.05)（图 2）。

The mean ΔNRS of the OA and PPSP subgroup was statistically significant at each follow- up point compared with baseline, but the mean ΔNRS was not significantly different between the OA and PPSP subgroups at each follow- up moment. When analyzing both the OA an PPSP population together, at each follow- up point, the ΔNRS of cooled RF compared with baseline was not significantly different to the ΔNRS of conventional RF compared with baseline. 

OA 和 PPSP亚组的平均ΔNRS 在每个随访点与基线相比具有统计学显着性，但在每个随访时刻OA和PPSP亚组的平均ΔNRS没有显着差异。当同时分析OA和PPSP人群时，在每个后续点，冷却RF的ΔNRS与基线相比与传统RF的ΔNRS与基线相比没有显着差异。

3. The non-inferiority outcome非劣效性结果

The non- inferiority comparison between conventional and cooled RF was performed on the combined OA and PPSP population due to the limited number of patients included in this trial.

The point estimate difference in NRS was 1 at 3 months but as the 95% CI (−0.6 to 2.7) includes the non- inferiority margin of 0.75, it is inconclusive at this point (figure 3).

由于本试验中纳入的患者数量有限，因此对 OA 和 PPSP 联合人群进行了常规和冷却 RF 之间的非劣效性比较。

NRS 的点估计差异在 3 个月时为 1，但由于 95% CI（-0.6 至 2.7）包括 0.75 的非劣效性界值，因此此时尚无定论（图 3）。

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