Lossada-Soto Elizabeth, Pazik Marissa, Horodyski Mary Beth, Vasilopoulos Terrie, de Faria Ludmila Barbosa, Mathews Carol, Hagen Jennifer
Department of Orthopaedic Surgery & Sports Medicine, University of Florida, PO Box 112727, Gainesville, FL, 32611-2727, USA.
Department of Anesthesiology, University of Florida, 1600 SW Archer Road, Gainesville, FL, 32610, USA.
Pilot Feasibility Stud. 2022 Aug 17;8(1):184. doi: 10.1186/s40814-022-01119-8.
Musculoskeletal trauma is one of the leading causes of disability in the USA and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues and post-traumatic stress disorder (PTSD) symptomology following their injury. These symptoms can develop across all spectrums of patients and are independent predictors of poor outcome. Access to mental health care is limited, expensive, and time intensive, and a large majority of the trauma population do not get to utilize this valuable resource. This leaves the burden of management on the orthopedic team, as they are often the only point of contact for the patient within the medical system.
This is a single-center, repeated measures, randomized controlled pilot study including up to 100 orthopedic trauma patients aged between 18 and 85 years of age. Subjects are approached during their index hospitalization and are randomized to one of two pharmaceutical interventions, fluoxetine (also known as Prozac) or calcium, for 9 months. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is supported for the treatment of PTSD by the American Psychiatric Association. It is low-cost and has minimal side effects and withdrawal symptoms if stopped suddenly. Calcium is a supplement with minimal side effects that is used in our study for its bone-healing potential. Feasibility will be indexed by recruitment feasibility, randomization feasibility, medical adherence, anti-depressant side effects, and fracture union rate. Subjects will complete physical and mental health surveys at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.
The goals of this exploratory clinical trial are to: develop a safe, feasible, and time-limited protocol effect of immediate (post-injury) treatment with fluoxetine for use by orthopedic providers and other non-mental health care providers treating victims of musculoskeletal trauma (Aim 1), and test the for preliminary effects of the protocol on development of PTSD symptomology and physical recovery in these patients (Aim 2). This study is novel in that it strives to prevent the development of symptomology from the time of injury and empowers surgeons to manage their patients in a more holistic manner.
ClinicalTrials.gov, NCT04850222 . Registered on April 20, 2021.
肌肉骨骼创伤是美国导致残疾的主要原因之一，其对生活质量的负面影响不仅限于身体恢复。超过50%的肌肉骨骼创伤受害者在受伤后会出现持续的心理健康问题和创伤后应激障碍（PTSD）症状。这些症状可能出现在所有类型的患者中，并且是预后不良的独立预测因素。获得心理健康护理的机会有限、费用高昂且耗时，绝大多数创伤患者无法利用这一宝贵资源。这使得骨科团队承担了管理负担，因为他们通常是患者在医疗系统中的唯一接触点。
这是一项单中心、重复测量、随机对照试验性研究，纳入年龄在18至85岁之间的最多100名骨科创伤患者。在患者首次住院期间对其进行招募，并随机分为两种药物干预之一，即氟西汀（也称为百忧解）或钙，为期9个月。氟西汀是一种选择性5-羟色胺再摄取抑制剂（SSRI），美国精神病学协会支持其用于治疗PTSD。它成本低，如果突然停药，副作用和戒断症状最小。钙是一种副作用最小的补充剂，在我们的研究中因其促进骨愈合的潜力而被使用。可行性将通过招募可行性、随机化可行性、药物依从性、抗抑郁药副作用和骨折愈合率来衡量。受试者将在基线、2周、6周、3个月、6个月和1年时完成身心健康调查。
这项探索性临床试验的目标是：制定一种安全、可行且限时的方案，用于骨科医生和其他治疗肌肉骨骼创伤受害者的非心理健康护理提供者在受伤后立即使用氟西汀进行治疗（目标1），并测试该方案对这些患者PTSD症状发展和身体恢复的初步影响（目标2）。这项研究的新颖之处在于，它努力从受伤时就预防症状的发展，并使外科医生能够以更全面的方式管理他们的患者。
ClinicalTrials.gov，NCT04850222。于2021年4月20日注册。
