Armour Mike, Smith Caroline A, Schabrun Siobhan, Steiner Genevieve Z, Zhu Xiaoshu, Lawson Kenny, Song Jing
NICM, Western Sydney University, Campbelltown Campus, Sydney, Australia.
Brain Rehabilitation and Neuroplasticity unit, Western Sydney University, Campbelltown Campus, Sydney, Australia.
Pilot Feasibility Stud. 2017 Jul 6;4:10. doi: 10.1186/s40814-017-0152-9. eCollection 2018.
Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP.
We will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation.
This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness.
Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (http://www.ANZCTR.org.au/ACTRN12617000053325.aspx).
子宫内膜异位症是全球慢性盆腔疼痛最常见的病因。非手术治疗仅对30%-50%的女性有效，且存在显著的副作用负担，导致停药率很高。手术可能有效，但费用高昂且具有侵入性，症状往往在5年内复发。早期证据表明，针灸可能对治疗子宫内膜异位症相关的慢性盆腔疼痛有效，显示出具有临床意义的镇痛效果。炎症水平和疼痛处理过程在慢性盆腔疼痛女性中均已显示发生改变。针灸已被证明在其他情况下可减轻炎症并改变中枢性疼痛处理，但目前缺乏针对子宫内膜异位症女性的研究。本可行性研究的目的是提供关于招募率、保留率、结局指标的适用性、数字评分量表中疼痛的最小临床重要差异以及针灸对子宫内膜异位症相关慢性盆腔疼痛的疼痛处理和炎症标志物的潜在影响的数据。
我们将纳入年龄在18-45岁之间、在过去5年内经腹腔镜诊断为子宫内膜异位症的女性。总共将招募30名参与者，并按1:1的比例随机分配接受针灸治疗或常规护理。针灸组的女性将每周接受两次45分钟的治疗，共8周（总计16次）。常规护理组的女性将继续其当前的治疗方案。主要可行性结局指标为招募率、保留率以及干预措施的安全性和可接受性；以患者为中心的次要结局指标包括0-10分的每日盆腔疼痛评分变化、子宫内膜异位症健康概况30（EHP-30）以及条件性疼痛调制、静息和任务相关脑电图活动及炎症标志物的变化。分析将在对分组情况不知情的情况下进行。
这是一项双臂、评估者盲法的随机对照可行性试验。将在基线时和8周后的试验完成时对数据进行比较。如果该治疗显示出潜在有效性的趋势，本可行性研究的结果将为一项规模更大、具备充分效力的临床试验提供参考。
澳大利亚新西兰临床试验注册中心，ACTRN12617000053325（http://www.ANZCTR.org.au/ACTRN12617000053325.aspx）。
