Reneker J C, Hassen A, Phillips R S, Moughiman M C, Donaldson M, Moughiman J
Department of Physical Therapy, School of Health Related Professions, University of Mississippi Medical Center, Jackson, MS, USA.
Walsh University, North Canton, OH, USA.
Scand J Med Sci Sports. 2017 Dec;27(12):2009-2018. doi: 10.1111/sms.12827. Epub 2017 Feb 17.
The purpose of this study was to (a) assess the feasibility of recruitment/retention of participants, protocol/resource management, and participant safety, and (b) estimate the size of the effect between the experimental and control groups. This was a feasibility study conducted as a prospective pilot double-blind randomized clinical trial. Subjects aged 10-23 years old with acute concussion and dizziness were enrolled from sports medicine centers. Forty-one participants were randomized into treatment and were seen for physical therapy beginning at 10 days post-concussion. Subjects in the experimental group received individually tailored, pragmatically delivered progressive interventions. Subjects in the control received prescriptive sham to minimally progressive interventions. The two primary outcomes were medical clearance for return-to-play and symptomatic recovery. The median number of days to medical clearance for the experimental group was 15.5 and for the control was 26. The median number of days to symptomatic recovery was 13.5 for the experimental group and was 17 for the control. According to Cox proportional hazards regression for time to medical release for return-to-play, the experimental group demonstrated a hazard ratio of 2.91 (95% CI: 1.01, 8.43) compared to the control. For time-to-symptomatic recovery, those in the experimental group demonstrated a hazard ratio of 1.99 (95% CI: 0.95, 4.15) compared to the control. The results indicate that it is feasible and safe to complete this type of intervention study. The results provide strong support for the allocation of resources to conduct well-powered randomized clinical trials of this intervention.
（a）评估招募/留住参与者、方案/资源管理以及参与者安全的可行性；（b）估计实验组与对照组之间的效应大小。这是一项可行性研究，作为前瞻性试点双盲随机临床试验开展。从运动医学中心招募了年龄在10至23岁之间、患有急性脑震荡和头晕的受试者。41名参与者被随机分组接受治疗，并在脑震荡后10天开始接受物理治疗。实验组的受试者接受个性化定制、切实可行的渐进性干预措施。对照组的受试者接受规定的假干预措施，干预程度最低。两个主要结局指标是恢复比赛的医学许可和症状恢复情况。实验组恢复比赛医学许可的天数中位数为15.5天，对照组为26天。实验组症状恢复的天数中位数为13.5天，对照组为17天。根据恢复比赛医学许可时间的Cox比例风险回归分析，与对照组相比，实验组的风险比为2.91（95%置信区间：1.01, 8.43）。对于症状恢复时间，与对照组相比，实验组的风险比为1.99（95%置信区间：0.95, 4.15）。结果表明，完成这类干预研究是可行且安全的。这些结果为分配资源开展该干预措施的充分有力的随机临床试验提供了有力支持。
