A randomized controlled trial to evaluate the effectiveness and safety of electro acupuncture and transcranial direct current stimulation with computerized cognitive rehabilitation in patients with vascular cognitive impairment.
- 作者列表："Park HK","Song MK","Kim JH","Han JY
BACKGROUND:Vascular cognitive impairment (VCI) refers to all cognitive disorders caused by cerebrovascular disorders. For the treatment, many types of pharmacologic and nonpharmacologic treatments are used but their underlying mechanisms and effects are unclear. Regarding nonpharmacologic treatment, electroacupuncture (EA), transcranial direct current stimulation (tDCS), and computerized cognitive rehabilitation treatment (CCRT) are effective. Here, we report the protocol for a randomized controlled trial of the effect and safety of combination therapy of EA or tDCS and CCRT in patients with VCI. METHODS:This study will be a prospective, outcome assessor-blinded, parallel-arm, randomized controlled clinical trial. Participants with cognitive impairment caused by stroke after 3 months of onset (n = 45) will be randomly assigned to a CCRT, combination therapy with EA and computerized cognitive rehabilitation treatment, or combination therapy with tDCS and computerized cognitive rehabilitation treatment group. All groups will receive treatment 3 times per week for 8 weeks, giving a total of 24 treatments. The CCRT group will perform a training task like shopping, calculating, and others and involving computerized cognitive assessment and brain training system (RehaCom) for 30 minutes. The combination therapy with EA and computerized cognitive rehabilitation treatment group will receive EA using 8 acupuncture points - baekhoe, sinjeong, both sides of pungji, 4 sites of sishencong - and will be applied using an EA stimulator and receive CCRT for 30 minutes at the same time. The combination therapy with tDCS and computerized cognitive rehabilitation treatment group will receive tDCS treatment and receive CCRT for 30 minutes at the same time. The primary outcome will be evaluated using the Lowenstein occupational therapy cognitive assessment, while other scales assessing walking ability, activities of daily living, and quality of life are considered secondary outcome measures. Outcomes will be evaluated before intervention, at the end of intervention 8 weeks after the first intervention, and 4 weeks after completion of the intervention program. DISCUSSION:This study aims to examine the effect and safety of combination therapy with EA or tDCS and CCRT in patients with VCI. This study can be useful in developing new treatment technologies using collaborative research with combined traditional Korean and conventional medicines. TRIAL REGISTRATION:This trial has been registered with cris.nih.go.kr (registration number, KCT 0003644 Registered 01 April 2019, http://cris.nih.go.kr).
背景: 血管性认知障碍 (VCI) 是指由脑血管疾病引起的所有认知障碍。对于治疗，使用了许多类型的药物和非药物治疗，但其潜在的机制和效果尚不清楚。关于非药物治疗，电针 (EA) 、经颅直流电刺激 (tDCS) 和计算机认知康复治疗 (CCRT) 是有效的。在此，我们报告了一项随机对照试验的方案，该试验旨在研究EA或tDCS和CCRT联合治疗VCI患者的效果和安全性。 方法: 本研究将是一项前瞻性、结果评估盲法、平行对照、随机对照临床试验。发病3个月后因卒中导致认知障碍的参与者 (n = 45) 将被随机分配到CCRT、EA联合治疗和计算机化认知康复治疗组，或tDCS联合治疗和计算机化认知康复治疗组。所有组每周治疗3次，共8周，共24次。CCRT小组将进行30分钟的训练任务，如购物、计算等，包括计算机认知评估和大脑训练系统 (RehaCom)。与EA和计算机认知康复治疗组的联合疗法将使用8个穴位-baekhoe，sinjeong，pungji的两侧，四神聪的4个部位-进行EA治疗，并使用EA刺激器进行应用，同时接受CCRT 30分钟。tDCS与计算机认知康复治疗组的联合治疗将接受tDCS治疗，同时接受CCRT 30 min。主要结局将使用Lowenstein职业疗法认知评估进行评估，而评估步行能力、日常生活活动和生活质量的其他量表被视为次要结局指标。结果将在干预前、干预结束时、第一次干预后8周和干预计划完成后4周进行评估。 讨论: 本研究旨在研究EA或tDCS和CCRT联合治疗VCI患者的效果和安全性。这项研究可以用于开发新的治疗技术，使用与韩国传统和传统药物相结合的合作研究。 试验注册: 本试验已在cris.nih.go.kr注册 (注册号，KCT 0003644 2019年4月01日注册， http://cris.nih.go.kr )。
METHODS:BACKGROUND:Maintaining a balance between nociception and analgesia perioperatively reduces morbidity and improves outcomes. Current intraoperative analgesic strategies are based on subjective and nonspecific parameters. The high-frequency heart rate (HR) variability index is purported to assess the balance between nociception and analgesia in patients under general anesthesia. This prospective observational study investigated whether intraoperative changes in the high-frequency HR variability index correlate with clinically relevant nociceptive stimulation and the addition of analgesics. METHODS:Instantaneous and mean high-frequency HR variability indexes were measured continuously in 79 adult subjects undergoing general anesthesia for laparoscopic cholecystectomy. The indexes were compared just before and 2 minutes after direct laryngoscopy, orogastric tube placement, first skin incision, and abdominal insufflation and just before and 6 minutes after the administration of IV hydromorphone. RESULTS:Data from 65 subjects were included in the final analysis. The instantaneous index decreased after skin incision ([SEM], 58.7 [2.0] vs 47.5 [2.0]; P < .001) and abdominal insufflation (54.0 [2.0] vs 46.3 [2.0]; P = .002). There was no change in the instantaneous index after laryngoscopy (47.2 [2.2] vs 40.3 [2.3]; P = .026) and orogastric tube placement (49.8 [2.3] vs 45.4 [2.0]; P = .109). The instantaneous index increased after hydromorphone administration (58.2 [1.9] vs 64.8 [1.8]; P = .003). CONCLUSIONS:In adult subjects under general anesthesia for laparoscopic cholecystectomy, changes in the high-frequency HR variability index reflect alterations in the balance between nociception and analgesia. This index might be used intraoperatively to titrate analgesia for individual patients. Further testing is necessary to determine whether the intraoperative use of the index affects patient outcomes.
METHODS:INTRODUCTION:Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation. METHODS:Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks. RESULTS:This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed. CONCLUSIONS:The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.
METHODS:INTRODUCTION:Enhanced recovery programmes are established as an essential part of laparoscopic colorectal surgery. Optimal pain management is central to the success of an enhanced recovery programme and is acknowledged to be an important patient reported outcome measure. A variety of analgesia strategies are employed in elective laparoscopic colorectal surgery ranging from patient-controlled analgesia to local anaesthetic wound infiltration catheters. However, there is little evidence regarding the optimal analgesia strategy in this cohort of patients. The LapCoGesic study aimed to explore differences in analgesia strategies employed for patients undergoing elective laparoscopic colorectal surgery and to assess whether this variation in practice has an impact on patient-reported and clinical outcomes. MATERIALS AND METHODS:A prospective, multicentre, observational cohort study of consecutive patients undergoing elective laparoscopic colorectal resection was undertaken over a two-month period. The primary outcome measure was postoperative pain scores at 24 hours. Data analysis was conducted using SPSS version 22. RESULTS:A total of 103 patients undergoing elective laparoscopic colorectal surgery were included in the study. Thoracic epidural was used in 4 (3.9%) patients, spinal diamorphine in 56 (54.4%) patients and patient-controlled analgesia in 77 (74.8%) patients. The use of thoracic epidural and spinal diamorphine were associated with lower pain scores on day 1 postoperatively (P < 0.05). The use of patient-controlled analgesia was associated with significantly higher postoperative pain scores and pain severity. DISCUSSION:Postoperative pain is managed in a variable manner in patients undergoing elective colorectal surgery, which has an impact on patient reported outcomes of pain scores and pain severity.