Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study
Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study
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DOI：
10.1007/s00167-008-0519-9
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发表时间：
2008-06-01
影响因子：
3.8
通讯作者：
Massari, Leo
中科院分区：
文献类型：
--
作者：
Benazzo, Francesco;Zanon, Giacomo;Massari, Leo
临床前研究表明，脉冲电磁场（PEMF）治疗可以限制促炎细胞因子对关节软骨的分解代谢作用，并有利于软骨细胞的合成代谢活性。前交叉韧带（ACL）重建通常通过关节镜手术进行，即使微创，也可能引起对关节软骨有害的炎性关节反应。在这项研究中，I-ONE PEMFs治疗ACL重建患者的效果进行了调查。研究终点为（1）通过国际膝关节文献委员会（IKDC）表格评估患者的功能恢复;（2）使用非甾体抗炎药（NSAID），这是控制关节疼痛和炎症所必需的。研究设计为前瞻性、随机和双盲。69例患者在基线时被纳入研究。在30、60和180天安排随访访视，然后进行2年随访访视。通过IKDC表格对患者进行评价，并要求报告NSAID的使用情况。患者随机接受活性药物或安慰剂治疗;活性器械在75 Hz下产生1.5 mT的磁场。指导患者使用刺激器（I-ONE），每天4小时，持续60天。所有患者均采用四股半腱肌和股薄肌技术重建ACL。基线时，两组之间的IKDC评分无差异。在随访访视时，SF-36健康调查评分显示，接受I-ONE刺激器治疗的患者组恢复更快，具有统计学显著性（P < 0.05）。非甾体类抗炎药的使用频率在活动期患者中低于对照组（P < 0.05）。活性治疗组关节肿胀消退和恢复正常活动范围的速度也更快（P < 0.05）。2年随访两组无统计学差异。此外，对于纵向分析，应用广义线性混合效应模型计算组x时间相互作用系数;该相互作用显示活性药物组和安慰剂组之间所有研究变量均存在显著差异（P < 0.0001）：SF-36健康调查、IKDC膝关节主观评价和VAS。29名患者（活性组15名;安慰剂组14名）同时接受ACL重建和ACL切除术;当分别分析时，两组之间SF-36健康调查评分的差异大于整个研究组中观察到的差异（P < 0.05）。本研究结果显示，活动组患者的功能恢复较早。没有观察到副作用，治疗耐受性良好。ACL重建后应始终考虑使用I-ONE，特别是在专业运动员中，以缩短恢复时间，限制关节炎性反应及其对关节软骨的分解代谢作用，并最终保护关节。
Pre-clinical studies have shown that treatment by pulsed electromagnetic fields (PEMFs) can limit the catabolic effects of pro-inflammatory cytokines on articular cartilage and favour the anabolic activity of the chondrocytes. Anterior cruciate ligament (ACL) reconstruction is usually performed by arthroscopic procedure that, even if minimally invasive, may elicit an inflammatory joint reaction detrimental to articular cartilage. In this study the effect of I-ONE PEMFs treatment in patients undergoing ACL reconstruction was investigated. The study end-points were (1) evaluation of patients' functional recovery by International Knee Documentation Committee (IKDC) Form; (2) use of non-steroidal anti-inflammatory drugs (NSAIDs), necessary to control joint pain and inflammation. The study design was prospective, randomized and double blind. Sixty-nine patients were included in the study at baseline. Follow-up visits were scheduled at 30, 60 and 180 days, followed by 2-year follow-up interview. Patients were evaluated by IKDC Form and were asked to report on the use of NSAIDs. Patients were randomized to active or placebo treatments; active device generated a magnetic field of 1.5 mT at 75 Hz. Patients were instructed to use the stimulator (I-ONE) for 4 h per day for 60 days. All patients underwent ACL reconstruction with use of quadruple hamstrings semitendinosus and gracilis technique. At baseline there were no differences in the IKDC scores between the two groups. At follow-up visits the SF-36 Health Survey score showed a statistically significant faster recovery in the group of patients treated with I-ONE stimulator (P < 0.05). NSAIDs use was less frequent among active patients than controls (P < 0.05). Joint swelling resolution and return to normal range of motion occurred faster in the active treated group (P < 0.05) too. The 2-year follow-up did not shown statistically significant difference between the two groups. Furthermore for longitudinal analysis the generalized linear mixed effects model was applied to calculate the group x time interaction coefficient; this interaction showed a significant difference (P < 0.0001) between the active and placebo groups for all investigated variables: SF-36 Health Survey, IKDC Subjective Knee Evaluation and VAS. Twenty-nine patients (15 in the active group; 14 in the placebo group) underwent both ACL reconstruction and meniscectomy; when they were analysed separately the differences in SF-36 Health Survey scores between the two groups were larger then what observed in the whole study group (P < 0.05). The results of this study show that patient's functional recovery occurs earlier in the active group. No side effects were observed and the treatment was well tolerated. The use of I-ONE should always be considered after ACL reconstruction, particularly in professional athletes, to shorten the recovery time, to limit joint inflammatory reaction and its catabolic effects on articular cartilage and ultimately for joint preservation.