跳至主要内容
临床试验/NCT07266922
NCT07266922
Enrolling By Invitation
不适用

Running Informed, Not Just Trained: A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年2月20日最近更新:

概览

阶段
不适用
状态
Enrolling By Invitation
入组人数
104
试验地点
1
主要终点
Clinical outcomes (pain)

概览

简要总结

Runners experience diverse lower extremity injuries, and the most common is patellofemoral pain (PFP)-commonly known as "runner's knee" and characterized by pain around and/or behind the kneecap. The aim of this study is to evaluate the effectiveness of a 6-week, self-directed, web-based education program for runners competing in the 2026 Boston Marathon. The study will evaluate outcomes, including pain, function, and marathon performance, in runners who use a web-based educational program designed to help them understand and manage knee pain. There will be two groups: Group 1 will receive the 6-week web-based educational program prior to the 2026 Boston Marathon, while Group 2 will serve as the wait-and-see control group (no intervention) prior to the marathon and then receive the same program 6 weeks after completing the marathon.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Insidious onset of peripatellar and/or retropatellar pain ≥3 months
  • Worst pain level in the previous week ≥3/10 on the numeric pain rating scale
  • Pain during at least two of the following tasks: prolonged sitting, kneeling, squatting, walking, running, jumping, and stair negotiation.
  • All participants must have access to an internet-enabled device (e.g., computer, tablet, smartphone) equipped with audio capabilities sufficient to engage with the web-based education platform

排除标准

  • History of lower extremity surgery
  • History of lower extremity pain or injury (other than patellofemoral pain) in the previous six months
  • History of patellar dislocation or subluxation
  • Internal derangement (e.g., meniscal lesion)
  • Ligamentous instability
  • Other sources of anterior knee pain (e.g., patellar tendinopathy, bursitis)

研究组 & 干预措施

Pre-Marathon Education

Experimental

This group will receive the educational platform for 6 weeks prior to the 2026 Boston Marathon. Participants will have access to MyKneeCap.com, a web-based platform designed to provide runners with evidence-based education on the physical and non-physical factors contributing to patellofemoral pain, as well as strategies for self-managing symptoms tailored specifically for runners.

干预措施: Education Platform-MyKneeCap.com (Behavioral)

Wait-and-See Control / Post-Marathon Education

Other

This group will serve as a wait-and-see control (no intervention) prior to the 2026 Boston Marathon. After completing the marathon, participants will receive access to MyKneeCap.com, a web-based platform designed to provide runners with evidence-based education on the physical and non-physical factors contributing to patellofemoral pain, as well as strategies for self-managing symptoms tailored specifically for runners.

干预措施: Education Platform-MyKneeCap.com (Behavioral)

结局指标

主要结局

Clinical outcomes (pain)

时间窗: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

Pain will be assessed for current pain and worst pain in the previous week using a 10-cm visual analog scale (VAS; 0=no pain; 10=worst pain imaginable), a reliable, valid, and responsive tool for evaluating treatment outcomes for patellofemoral pain.

Clinical outcomes (self-reported function)

时间窗: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

Self-reported function will be evaluated using the 11-item Knee Injury and Osteoarthritis Outcome Score-Patellofemoral subscale (KOOS-PF; 0=extreme disability; 100=no disability), a reliable tool with the highest content validity for patellofemoral pain.

Clinical outcomes (global rating of change)

时间窗: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

Global rating of change will be assessed for perceived recovery using a 7-point Likert scale (much worse, worse, slightly worse, no change, slightly better, better, or much better). The global rating of change scale is a reliable, clinically relevant, and patient-centered measure for interpreting meaningful improvements.

次要结局

  • Psychological function (fear-avoidance beliefs)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Psychological function (pain self-efficacy)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Patient satisfaction(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Marathon performance (finish time)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Marathon performance (division ranking)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Medical service use(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Secondary musculoskeletal complaints(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Return to running readiness(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Barriers and facilitators (confidence in self-management)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Barriers and facilitators (usability of the education platform)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)
  • Barriers and facilitators (treatment expectations)(6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sungwan Kim

Principal Investigator

Boston Children's Hospital

研究点 (1)

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