Back in the Game: An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis: A Multi-Center Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Change in Micheli Functional Scale (MFS)
研究概览
简要总结
Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.
详细描述
A total of 60 adolescent athletes ages 10-19 with an active spondylolysis will be recruited and enrolled via two study sites. Enrolled athletes will be randomly assigned into either 1) novel IFPP, which will begin rehabilitation immediately upon diagnosis, or 2) control (standard care), which will not begin rehabilitation until lumbar pain resolution.
Aim 1: Compare the safety and tolerability of the IFPP with a standard care approach (control) after diagnosis of active spondylolysis. Working hypothesis: Participation in the IFPP will not increase adverse events or delay recovery in adolescents compared to those in the control group who do not exercise during the immediate period following diagnosis of spondylolysis.
Aim 2: Assess the effects of the IFPP compared to a standard care approach (control) on improved outcomes among adolescent athletes with an active spondylolysis. Working hypothesis: Athletes randomly assigned in the IFPP will have greater and quicker improvements in outcomes (Function, Pain, Quality of Life, and Edema on MRI) than athletes in the control group.
All participants will rest from sport until they meet the return-to-sport criteria. After randomizing, both IFPP and control groups will receive physical therapy (PT) care two times/week until they meet the return-to-sport criteria. Each PT session will last approximately one hour, and both groups will use the same return-to-sport criteria. However, the difference between the IFPP and control group is the time when PT begins. The IFPP group will begin PT immediately upon diagnosis, while the control group will wait until lumbar pain resolves. Interventions in both groups will be standardized across both sites.
Return-to-Sport Criteria: The athlete must meet all below criteria to be cleared to return to sport. Athletes will not be told the return-to-sport criteria as this may encourage athletes to under report pain to be cleared sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Micheli Functional Scale (MFS)
时间窗: Baseline, 1 month, 3 months, 6 months, 1 year
The Micheli Functional Scale is a measure of function and pain designed for adolescent athletes with low back pain. The MFS is score on 0-100% scale with 0% representing no disability and 100% representing maximum disability.
Change in edema on MRI
时间窗: Baseline, 3 months
Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis.
Change in Quality of Life
时间窗: Baseline, 1 month, 3 months, 6 months, 1 year
Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a 23-item health status instrument that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item uses a 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life.
Time to return to sport (days)
时间窗: 1-6 months
The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport.
次要结局
- Change in Fear Avoidance Beliefs(Baseline, 1 month, 3 months, 6 months, 1 year)
- Change in Cross Sectional Area of Lumbar Multifidus(Baseline, 3 months)
- Change in Depressive Symptoms(Baseline, 1 month, 3 months, 6 months, 1 year)
研究者
Mitchell Selhorst
Physical Therapist/Principal Investigator
Nationwide Children's Hospital