Hiemstra Laurie A, Heard S Mark, Sasyniuk Treny M, Buchko Greg L, Reed Jeremy G, Monteleone Bradley J
Banff Sport Medicine and Mineral Springs Hospital, Banff, Alberta, Canada.
Am J Sports Med. 2009 Jan;37(1):56-64. doi: 10.1177/0363546508322896. Epub 2008 Sep 18.
This study will attempt to evaluate the efficacy of knee immobilization on patient pain levels after an anterior cruciate ligament reconstruction.
There is no difference in visual analog scale pain scores 2 days after anterior cruciate ligament reconstruction between patients who wear a knee immobilizer and those who do not wear a knee immobilizer.
Randomized clinical trial; Level of evidence, 1.
Patients aged 18 to 40 years who met study inclusion criteria were eligible. Patients meeting intraoperative inclusion criteria were randomized (immobilizer or no immobilizer) after wound closure. The immobilizer used was a soft, unhinged brace with Velcro straps. Preoperative, intraoperative, and postoperative protocols were standardized. The primary outcome was patient self-assessed pain using a 0-to-100-mm visual analog scale at day 2 after surgery. Secondary outcomes included pain and analgesic use in the first 14 days after surgery, complications, and range of motion (approximately 3 weeks postoperatively). A sample size estimate was calculated and resulted in the need for 44 patients per group.
A total of 102 patients were enrolled; 88 patients were randomized, and 14 were excluded intraoperatively. There was no difference in mean visual analog scale pain scores at 2 days after surgery between immobilized and nonimmobilized patients (32.6 and 35.2, respectively; P = .59; difference, -2.6; 95% confidence interval, -12.2 to 6.9). There were no differences between groups in medication consumed, range of motion, or complications. Pain and analgesic use were the same for both groups at 7 and 14 days postoperatively.
No differences in pain or any of the secondary outcomes were detected between immobilized and nonimmobilized patients at any point during the first 14 days after anterior cruciate ligament reconstruction.
本研究将尝试评估膝关节固定对前交叉韧带重建术后患者疼痛程度的疗效。
在前交叉韧带重建术后2天，佩戴膝关节固定器的患者与未佩戴膝关节固定器的患者在视觉模拟评分法疼痛评分上没有差异。
随机临床试验；证据等级，1级。
符合研究纳入标准的18至40岁患者符合条件。符合术中纳入标准的患者在伤口闭合后随机分组（固定器组或无固定器组）。使用的固定器是一种带有尼龙搭扣带的柔软、无铰链支具。术前、术中和术后方案均标准化。主要结局是术后第2天患者使用0至100毫米视觉模拟评分法进行的自我评估疼痛。次要结局包括术后前14天的疼痛和镇痛药物使用、并发症以及活动范围（术后约3周）。计算了样本量估计值，结果每组需要44名患者。
共纳入102例患者；88例患者被随机分组，14例在术中被排除。固定组和非固定组患者术后2天的平均视觉模拟评分法疼痛评分无差异（分别为32.6和35.2；P = 0.59；差异为-2.6；95%置信区间为-12.2至6.9）。两组在药物消耗、活动范围或并发症方面无差异。两组术后7天和14天的疼痛和镇痛药物使用情况相同。
在前交叉韧带重建术后的前14天内，固定组和非固定组患者在疼痛或任何次要结局方面均未检测到差异。
