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Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial.

扰流器治疗化疗神经病: 一项随机II期试点试验。

  • 影响因子:2.83
  • DOI:10.1007/s00520-019-04881-3
  • 作者列表:"Loprinzi C","Le-Rademacher JG","Majithia N","McMurray RP","O'Neill CR","Bendel MA","Beutler A","Lachance DH","Cheville A","Strick DM","Black DF","Tilburt JC","Smith TJ
  • 发表时间:2020-03-01
Abstract

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.

摘要

引言: 化疗引起的周围神经病变 (CIPN) 是一个突出的临床问题,有效的治疗手段有限。初步的非随机临床试验数据支持扰频器治疗在这种情况下是有帮助的。 方法: 如果患者在注册前一周有CIPN症状至少 3 个月,CIPN相关刺痛或疼痛的严重程度至少为 4/10,则符合条件。他们随机接受扰频器治疗与经皮神经电刺激 (TENS) 治疗 2 周。使用患者报告结局 (PROs) 在治疗期间每天测量疗效和毒性 2 周,然后每周测量 8 周。 结果: 本研究累积了 50 例患者,2 个研究组各 25 例; 46 例患者可评价。在 2 周的治疗过程中,有两倍于基线疼痛、刺痛和麻木评分的患者至少有 50% 的记录改善,与TENS治疗的患者相比 (36-56%,而每种症状为 16-28%)。在治疗 12 周内,“神经病变症状” 、疼痛和生活质量的总体印象变化评分也得到类似改善。扰频器组的患者比TENS组的患者更有可能向其他患者推荐他们的治疗,在 2 周治疗期间和 8 周随访期间 (p <0.0001)。观察到最小毒性。 结论: 这项初步试验的结果是积极的,支持开展关于使用扰频器治疗CIPN的进一步研究。

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影响因子:2.27
发表时间:2020-04-01
DOI:10.1213/ANE.0000000000004180
作者列表:["Anderson TA","Segaran JR","Toda C","Sabouri AS","De Jonckheere J"]

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.

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影响因子:2.83
发表时间:2020-03-01
DOI:10.1007/s00520-019-04881-3
作者列表:["Loprinzi C","Le-Rademacher JG","Majithia N","McMurray RP","O'Neill CR","Bendel MA","Beutler A","Lachance DH","Cheville A","Strick DM","Black DF","Tilburt JC","Smith TJ"]

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.

翻译标题与摘要 下载文献
影响因子:0.72
发表时间:2020-01-01
DOI:10.1308/rcsann.2019.0091
作者列表:["Brown L","Gray M","Griffiths B","Jones M","Madhavan A","Naru K","Shaban F","Somnath S","Harji D","NoSTRA (Northern Surgical Trainees Reseach Association)."]

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.

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