【疼痛专题】双极射频消融膝上内侧(SM)、上外侧(SL)和下内侧(IM)膝部神经治疗慢性骨关节炎膝关节疼痛

Variability in anatomy in the knees supports the use of aggressive lesioning techniques such as bipolar- radiofrequency ablation (RFA) to treat knee osteoarthritis (KOA). There are no randomized controlled trials evaluating the efficacy of bipolar- RFA.

膝关节解剖的可变性支持使用侵袭性损伤技术，如双极射频消融术(RFA)来治疗膝骨性关节炎(KOA)。目前还没有评估双极射频消融术疗效的随机对照试验。

Sixty- four patients with KOA who experienced >50% pain relief from prognostic superomedial, superolateral and inferomedial genicular nerve blocks were randomly assigned to receive either genicular nerve local anesthetic and steroid injections with sham- RFA or local anesthetic and steroid plus bipolar- RFA. Participants and outcome adjudicators were blinded to allocation.

The primary outcome was Visual Analog Scale pain score 12 months postprocedure. Secondary outcome measures included Western Ontario and McMaster Universities Arthritis (WOMAC) and Patient Global Improvement- Indexes (PGI- I).

64例膝关节骨性关节炎患者，经膝内侧上、外侧、下内侧神经阻滞后疼痛缓解率>50%，随机分为膝神经局麻药和类固醇注射加假射频消融术或局麻药和类固醇加双极射频消融术。参与者和结果评审员采用盲法，对分配情况不知情。

主要结果是术后12个月视觉模拟评分疼痛评分。

次要结果指标包括WOMAC和患者全球改善指数(PGI-I)。

Both groups experienced significant reductions in pain, with no significant differences observed at 12 months (reduction from 5.7±1.9 to 3.2±2.6 in the RFA- group vs from 5.0±1.4 to 2.6±2.4 in the control- group (p=0.40)) or any other time point. No significant changes were observed between groups for WOMAC and PGI- I at the primary endpoint, with only the control group experiencing a significant improvement in function at 12- month follow- up (mean reduction from 91.2±38.2 to 67.1±51.9 in the RFA- group (p=0.06) vs from 95.8±41.1 to 60.6±42.8 in the control group (p=0.001); p=0.85 between groups).

两组患者术后12个月疼痛均明显减轻(RFA组从5.7±1.9降至3.2±2.6，对照组从5.0±1.4降至2.6±2.4，P=0.40)。两组间的WOMAC和PGI-I均无显著变化，仅对照组在12个月随访时的功能有显著改善(RFA组从91.2±38.2降至67.1±51.9(p=0.06)，对照组从95.8±41.1降至60.6±42.8(p=0.001)；组间p=0.85)。

Our failure to find efficacy for genicular nerve RFA, coupled with evidence showing that a plenitude of nerves supply the knee joint and preliminary studies indicating superiority of lesioning strategies targeting more than three nerves, suggest controlled trials using more aggressive lesioning strategies are warranted.

我们未能发现膝部神经RFA的有效性，再加上有证据表明膝关节有丰富的神经供应，以及初步研究表明针对3条以上神经的损伤策略的优越性，建议使用更积极的损伤策略进行对照试验。

1. At the 12- month primary endpoint, there were no statistical differences in the primary outcome measure, average VAS pain score (in RFA group 3.2±2.6 vs 2.6±2.4 in control group; p=0.40), or at any other time point.

在12个月的主要终点，主要结果测量、平均VAS疼痛评分(RFA组3.2±2.6比对照组2.6±2.4；p=0.40)或任何其他时间点均无统计学差异。

2. The mean difference from baseline in average VAS score also failed to reach statistical significance (2.3±2.8 in the RFA group vs 2.2±2.4 in the sham group; p=0.73). The difference between the control and RFA group for this outcome measure was significant only at the 4- month time point (mean difference from baseline 2.5±2.5 in the RFA group vs 1.1±2.7 in the control group; p=0.04).

平均VAS评分与治疗前比较差异亦无统计学意义(RFA组为2.3±2.8，假手术组为2.2±2.4；p=0.73)。在4个月的时间点上，对照组和RFA组之间的这一结果测量的差异是显著的(RFA组与基线的平均差异为2.5±2.5，对照组为1.1±2.7；p=0.04)

3.Neither the difference between groups in the overall WOMAC score (67.1±51.9 in the RFA group vs 60.6±42.8 in the control group; p=0.85) nor the mean reduction from baseline in the overall WOMAC score (17.7±49.2 in the RFA group vs 24.6±38.5 in the control group; p=0.70) reached statistical significance at the 12 month primary endpoint, or any other time point. For individual WOMAC subscales, there were no differences in mean scores or mean reductions from baseline in any subscore at 12 months or other follow- up periods. 

两组间WOMAC总分的差异(RFA组为67.1±51.9，对照组为60.6±42.8；p=0.85)和WOMAC总分较基线的平均下降(RFA组为17.7±49.2，对照组为24.6±38.5；p=0.70)在12个月的主要终点或任何其他时间点都没有统计学意义。对于单独的WOMAC子量表，在12个月或其他随访期，任何子量表的平均分数或平均减分率与基线没有差异。

4. Mean PGI- I scores did not significantly differ between groups at 12 months (2.8±1.3 in the RFA group vs 2.6±1.3 in sham group; p=0.56) or other time points.

两组在12个月时的平均PGI-I评分(RFA组为2.8±1.3，假手术组为2.6±1.3；p=0.56)或其他时间点之间无显著差异。

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