Data_Sheet_1_Efficacy of transcranial direct current stimulation for improving postoperative quality of recovery in elderly patients undergoing lower limb major arthroplasty: a randomized controlled substudy.docx

BackgroundPrevious studies have demonstrated improvements in motor, behavioral, and emotional areas following transcranial direct current stimulation (tDCS), but no published studies have reported the efficacy of tDCS on postoperative recovery quality in patients undergoing lower limb major arthroplasty. We hypothesized that tDCS might improve postoperative recovery quality in elderly patients undergoing lower limb major arthroplasty.
MethodsNinety-six patients (≥65 years) undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized to receive 2 mA tDCS for 20 min active-tDCS or sham-tDCS. The primary outcome was the 15-item quality of recovery (QoR-15) score on postoperative day one (Т2). Secondary outcomes included the QoR-15 scores at the 2nd hour (T1), the 1st month (Т3), and the 3rd month (Т4) postoperatively, numeric rating scale scores, and fatigue severity scale scores.
ResultsNinety-six elderly patients (mean age, 71 years; 68.7% woman) were analyzed. Higher QoR-15 scores were found in the active-tDCS group at T2 (123.0 [114.3, 127.0] vs. 109.0 [99.3, 115.3]; median difference, 13.0; 95% CI, 8.0 to 17.0; p < 0.001). QoR-15 scores in the active-tDCS group were higher at T1 (p < 0.001), T3 (p = 0.001), and T4 (p = 0.001). The pain scores in the active-tDCS group were lower (p < 0.001 at motion; p < 0.001 at rest). The fatigue degree scores were lower in the active-tDCS group at T1 and T2 (p < 0.001 for each).
ConclusiontDCS may help improve the quality of early recovery in elderly patients undergoing lower limb major arthroplasty.
Clinical trial registrationThe trial was registered at the China Clinical Trial Center (ChiCTR2200057777, https://www.chictr.org.cn/showproj.html?proj=162744).

研究背景
既往研究已证实，经颅直流电刺激（transcranial direct current stimulation, tDCS）可改善运动、行为及情感领域的功能，但目前尚无已发表的研究报道经颅直流电刺激对接受下肢大型关节置换术患者的术后康复质量的疗效。本研究假设，经颅直流电刺激可改善接受下肢大型关节置换术的老年患者的术后康复质量。

研究方法
将96例年龄≥65岁、拟行全髋关节置换术（total hip arthroplasty, THA）或全膝关节置换术（total knee arthroplasty, TKA）的患者随机分为两组，分别接受2 mA、时长20分钟的真经颅直流电刺激（active-tDCS）或假经颅直流电刺激（sham-tDCS）。主要结局指标为术后第1天（时间点2，T2）的15项康复质量评分（quality of recovery-15, QoR-15）。次要结局指标包括术后第2小时（T1）、术后第1个月（T3）及术后第3个月（T4）的QoR-15评分、数字疼痛评分量表（numeric rating scale, NRS）评分及疲劳严重程度量表评分。

研究结果
最终共纳入96例老年患者进行分析，平均年龄为71岁，女性占比68.7%。在T2时间点，真刺激组的QoR-15评分显著更高：123.0 [114.3, 127.0] 对比 109.0 [99.3, 115.3]；中位数差值为13.0；95%置信区间为8.0~17.0；p<0.001。真刺激组在T1、T3及T4时间点的QoR-15评分亦显著更高（T1：p<0.001；T3：p=0.001；T4：p=0.001）。真刺激组的疼痛评分更低：活动时p<0.001，静息时p<0.001。真刺激组在T1及T2时间点的疲劳程度评分亦更低（两组比较均p<0.001）。

研究结论
经颅直流电刺激有助于改善接受下肢大型关节置换术的老年患者的早期康复质量。

临床试验注册
本试验已在中国临床试验注册中心注册（ChiCTR2200057777，https://www.chictr.org.cn/showproj.html?proj=162744）。