背景:慢性疼痛影响约800万加拿大人(约20%),影响他们的身心健康,同时给医疗保健系统带来每年超过600亿美元的成本。的确,患者通常在几年内接受多种药物的试验,而症状却没有减轻。因此,迫切需要确定慢性疼痛的新疗法,以改善患者的生活质量,增加治疗选择的可用性,减轻医疗保健系统的负担。
目的:本研究的主要目的是研究一项平行三臂先导随机对照试验的可行性,该试验将患者随机分配给氯胺酮,认知行为疗法(CBT)和正念冥想(MM)训练(CBT/MM),或静脉注射氯胺酮和CBT/MM的组合。次要结果是评估静脉内氯胺酮和CBT/MM联合治疗慢性疼痛与CBT/MM或单独静脉内氯胺酮相比的耐久性和功效(在研究的第20周评估)。
方法:这是一个单中心,16周,3臂试点研究将在圣迈克尔医院的慢性疼痛诊所进行,多伦多,安大略省,每年接受1000次推荐。将在总共20周的研究中招募患者。被分配CBT/MM治疗的参与者将从第1周到第16周接受远程每周心理治疗,包括通过NexJHealthInc(NexJHealth)平台进行的健康指导。被分配氯胺酮输注治疗的患者将在第2、7和12周每月接受氯胺酮输注治疗。被分配氯胺酮+CBT/MM的患者将接受1至16周的每周心理治疗,包括以及第2、7和12周的氯胺酮输注治疗。我们将评估招聘率,同意率,提款率,坚持,缺少数据,和不良事件作为试点结果措施。次要临床结果包括疼痛强度和疼痛干扰相对于基线的变化。
结果:截至2023年11月1日,招聘过程尚未启动。鉴于招聘,同意,以及这项可行性研究的30名参与者的干预目标,每位患者接受为期20周的监测和治疗,我们预计到2025年12月完成这项研究。
结论:本研究评估了开展一项3臂随机对照试验的可行性,以检查氯胺酮给药与CBT/MM同时使用对慢性神经性疼痛人群的影响。这项试点随机对照试验的结果将为更大规模的随机对照试验的发展提供信息。未来的研究将旨在包括一个足够功率的样品,将告知关于最佳治疗校准和治疗效果持续时间的决定。
背景:ClinicalTrials.govNCT05639322;https://classic.clinicaltrials.gov/ct2/show/NCT05639322.
■PRR1-10.2196/54406。
BACKGROUND: Chronic pain affects approximately 8 million Canadians (~20%), impacting their physical and mental health while burdening the health care system with costs of upwards of US $60 billion a year. Indeed, patients are often trialed on numerous medications over several years without reductions to their symptoms. Therefore, there is an urgent need to identify new therapies for chronic pain to improve patients\' quality of life, increase the availability of treatment options, and reduce the burden on the health care system.
OBJECTIVE: The primary objective of this study is to examine the feasibility of a parallel 3-arm pilot randomized controlled trial whereby patients are randomized to either intravenous ketamine alone, cognitive behavioral therapy (CBT) and mindfulness meditation (MM) training (CBT/MM), or the combination of intravenous ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination intravenous ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or intravenous ketamine alone (assessed at week 20 of the study).
METHODS: This is a single-center, 16-week, 3-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael\'s Hospital, Toronto, Ontario, which receives 1000 referrals per year. Patients will be enrolled in the study for a total of 20 weeks. Participants who are allocated CBT/MM therapy will receive remote weekly psychotherapy from week 1 to week 16, inclusive of health coaching administered through the NexJ Health Inc (NexJ Health) platform. Patients who are allocated ketamine-infusion therapy will receive monthly ketamine infusion treatments on weeks 2, 7, and 12. Patients who are allocated ketamine+CBT/MM will receive weekly psychotherapy from weeks 1 to 16, inclusive, as well as ketamine infusion treatments on weeks 2, 7, and 12. We will be assessing recruitment rates, consent rates, withdrawal rates, adherence, missing data, and adverse events as pilot outcome measures. Secondary clinical outcomes include changes relative to baseline in pain intensity and pain interference.
RESULTS: As of November 1, 2023, the recruitment process has not been initiated. Given the recruitment, consent, and intervention target of 30 participants for this feasibility study, with each patient undergoing monitoring and treatments for a course of 20 weeks, we expect to complete the study by December 2025.
CONCLUSIONS: This study assesses the feasibility of conducting a 3-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a population with chronic neuropathic pain. The results of this pilot randomized controlled trial will inform the development of a larger-scale randomized controlled trial. Future studies will be aimed at including a sufficiently powered sample that will inform decisions about optimal treatment calibration and treatment effect duration.
BACKGROUND: ClinicalTrials.gov NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322.
UNASSIGNED: PRR1-10.2196/54406.