Department of Psychology, Faculty of Science, Memorial University of Newfoundland, St. John's, Newfoundland, Canada
Department of Psychology, Faculty of Arts, University of Calgary, Calgary, Alberta, Canada.
BMJ Open. 2021 Sep 23;11(9):e055039. doi: 10.1136/bmjopen-2021-055039.
Current treatments for chronic pain (eg, opioids) can have adverse side effects and rarely result in resolution of pain. As such, there is a need for adjuvant analgesics that are non-addictive, have few adverse side effects and are effective for pain management across several chronic pain conditions. Oxytocin is a naturally occurring hormone that has gained attention for its potential analgesic properties. The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.
This is a placebo-controlled, triple-blind, sequential, within-subject crossover trial. Adults with chronic neuropathic, pelvic and musculoskeletal pain will be recruited from three Canadian provinces (British Columbia, Alberta and Newfoundland and Labrador, respectively). Enrolled patients will provide one saliva sample pretreatment to evaluate basal oxytocin levels and polymorphisms of the oxytocin receptor gene before being randomised to one of two trial arms. Patients will self-administer three different oxytocin nasal sprays twice daily for a period of 2 weeks (ie, 24 IU, 48 IU and placebo). Patients will complete daily diaries, including standardised measures on day 1, day 7 and day 14. Primary outcomes include pain and pain-related interference. Secondary outcomes include emotional function, sleep disturbance and global impression of change. Intention-to-treat analyses will be performed to evaluate whether improvement in pain and physical function will be observed posttreatment.
Trial protocols were approved by the Newfoundland and Labrador Health Research Ethics Board (HREB #20227), University of British Columbia Clinical Research Ethics Board (CREB #H20-00729), University of Calgary Conjoint Health Research Ethics Board (REB20 #0359) and Health Canada (Control # 252780). Results will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
NCT04903002; Pre-results.
目前治疗慢性疼痛的方法（例如阿片类药物）可能会产生不良反应，而且很少能彻底缓解疼痛。因此，需要寻找一种非成瘾性、不良反应少且对多种慢性疼痛疾病都有效的辅助镇痛药物。催产素是一种内源性激素，因其潜在的镇痛特性而受到关注。本试验旨在评估鼻内给予催产素对慢性疼痛成人疼痛和功能的疗效。
这是一项安慰剂对照、三盲、序贯、自身交叉对照试验。将从加拿大三个省份（不列颠哥伦比亚省、艾伯塔省和纽芬兰和拉布拉多省）招募患有慢性神经性、盆腔和肌肉骨骼疼痛的成年人。入组患者将在被随机分配到两个试验臂之前，提供一份预处理唾液样本以评估基础催产素水平和催产素受体基因的多态性。患者将每天两次自我给予三种不同剂量的催产素鼻喷剂，持续 2 周（即 24IU、48IU 和安慰剂）。患者将在第 1 天、第 7 天和第 14 天完成每日日记，包括标准测量。主要结局包括疼痛和与疼痛相关的干扰。次要结局包括情绪功能、睡眠障碍和总体变化印象。将进行意向治疗分析，以评估治疗后疼痛和身体功能是否会改善。
试验方案已获得纽芬兰和拉布拉多健康研究伦理委员会（HREB #20227）、不列颠哥伦比亚大学临床研究伦理委员会（CREB #H20-00729）、卡尔加里大学联合健康伦理委员会（REB20 #0359）和加拿大卫生部（注册号 252780）的批准。结果将通过在同行评议期刊上发表和在科学会议上发表来传播。
NCT04903002；预结果。
