Gouveia Kyle, Sprague Sheila, Gallant Jodi L, MacRae Sarah, Del Fabbro Gina, Bzovsky Sofia, McKay Paula, Johal Herman, Busse Jason W
Department of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Pilot Feasibility Stud. 2025 Jan 11;11(1):3. doi: 10.1186/s40814-024-01592-3.
Outcomes following surgery to operatively manage extremity fractures are variable, and up to two-thirds of patients report chronic post-surgical pain. Preliminary evidence suggests that psychotherapy directed at improving coping skills and reducing somatic vigilance may improve outcomes among fracture patients. The objective of this pilot study was to test the feasibility and acceptability of a randomized controlled trial comparing an online cognitive behavioural therapy (CBT) program versus usual care in patients with an operatively managed open or closed extremity fracture.
We conducted a single-centre internal pilot study over a 10-month period in patients with at least one operatively managed open or closed fracture of the appendicular skeleton. Participants were randomized to an online CBT program or usual care and followed for 12 months. The goals of our pilot study were to determine an acceptable rate of recruitment, the degree to which participants randomized to CBT were compliant with treatment, the site investigator's ability to adhere to study protocol and data collection procedures, and our ability to achieve high follow-up rates. Feasibility criteria were evaluated using a graded "traffic light" approach, in which "green light" indicates moving forward with the definitive trial, "yellow light" indicates proceeding with modifications to the protocol and trial procedures, and "red light" indicates a definitive trial is not feasible without significant protocol and trial procedure modifications.
We enrolled 94 participants over 10 months, which resulted in a "yellow light" for recruitment. Participant compliance with completion of the online CBT program received a "yellow light", with 60% of participants who were randomized to CBT completing all seven modules. However, 40% of participants in the CBT-arm withdrew from the program, resulting in a "red light". Adherence with the study protocol activities at baseline was relatively high (88%) which resulted in a "yellow light". Follow-up was 85% (80 of 94) at 12 months, resulting in a "yellow light".
These results suggest feasibility of a definitive, multi-centre trial to compare CBT versus usual care in the management of persistent post-operative pain in fracture patients despite the pilot phase identifying some challenges with enrollment timelines, compliance with the CBT program, and participant follow-up. For the definitive trial, we will expand participant recruitment to additional centres and implement strategies to optimize participant engagement and compliance with the CBT program and follow-up.
ClincialTrials.gov (NCT04274530). Registered February 18, 2020, https://classic.
gov/ct2/show/NCT04274530 .
手术治疗四肢骨折后的结果存在差异，多达三分之二的患者报告有慢性术后疼痛。初步证据表明，旨在提高应对技能和降低躯体警觉性的心理治疗可能会改善骨折患者的预后。这项试点研究的目的是测试一项随机对照试验的可行性和可接受性，该试验比较在线认知行为疗法（CBT）项目与常规护理对接受手术治疗的开放性或闭合性四肢骨折患者的效果。
我们在10个月的时间里对至少有一处接受手术治疗的开放性或闭合性四肢骨骼骨折患者进行了单中心内部试点研究。参与者被随机分为在线CBT项目组或常规护理组，并随访12个月。我们试点研究的目标是确定可接受的招募率、随机分配到CBT组的参与者对治疗的依从程度、现场研究者遵守研究方案和数据收集程序的能力，以及我们实现高随访率的能力。可行性标准采用分级“交通信号灯”方法进行评估，其中“绿灯”表示进行确定性试验，“黄灯”表示对方案和试验程序进行修改后继续进行，“红灯”表示在不进行重大方案和试验程序修改的情况下确定性试验不可行。
我们在10个月内招募了94名参与者，这导致招募方面亮起“黄灯”。参与者对在线CBT项目完成情况的依从性亮起“黄灯”，随机分配到CBT组的参与者中有60%完成了所有七个模块。然而，CBT组中有40%的参与者退出了该项目，这亮起了“红灯”。基线时对研究方案活动的依从性相对较高（88%），这亮起了“黄灯”。12个月时的随访率为85%（94名中的80名），这亮起了“黄灯”。
这些结果表明，尽管试点阶段在入组时间、对CBT项目的依从性和参与者随访方面发现了一些挑战，但在骨折患者持续性术后疼痛管理中比较CBT与常规护理的确定性多中心试验仍具有可行性。对于确定性试验，我们将扩大参与者招募范围至其他中心，并实施策略以优化参与者参与度以及对CBT项目和随访的依从性。
ClinicalTrials.gov（NCT04274530）。于2020年2月18日注册，https://classic.
gov/ct2/show/NCT04274530 。
