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Enrolling by Invitation

NCT Number: NCT07266922

A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain

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.

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Key information

Conditions

Patellofemoral Pain Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Education Platform-MyKneeCap.com

Behavioral

This intervention uses MyKneeCap.com, a free, web-based educational platform designed to help runners understand their knee pain. The platform provides information about patellofemoral pain and includes exercise programs aimed at reducing pain and improving knee function. This intervention does not involve any drugs, devices, or other procedural components.

Primary outcomes

  1. Clinical outcomes (pain)

    Time frame: 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.

  2. Clinical outcomes (self-reported function)

    Time frame: 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.

  3. Clinical outcomes (global rating of change)

    Time frame: 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.

Secondary outcomes

  1. Psychological function (fear-avoidance beliefs)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Fear-avoidance beliefs will be quantified using the 5-item Fear-Avoidance Beliefs Questionnaire-Physical Activity subscale (FABQ-PA; 0=no fear-avoidance; 24=extreme fear-avoidance). The FABQ-PA is a reliable and valid tool and represents a key psychological profile in patellofemoral pain management.

  2. Psychological function (pain self-efficacy)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Pain self-efficacy will be quantified using the 10-item Pain Self-Efficacy Questionnaire (PSEQ; 0=no self-efficacy; 60=extreme self-efficacy). The PSEQ is a reliable and valid tool and represents a key psychological profile in patellofemoral pain management.

  3. Patient satisfaction

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Satisfaction during the preceding six weeks of marathon training will be rated on a 5-point Likert scale (very dissatisfied, somewhat dissatisfied, neither, somewhat satisfied, or very satisfied).

  4. Marathon performance (finish time)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Finish time will be evaluated by comparing the official finish time to the participant's intended finish time (in minutes).

  5. Marathon performance (division ranking)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Division ranking will be evaluated by comparing the division ranking to the participant's intended division ranking (in rank).

  6. Medical service use

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Intra-event medical encounters for knee pain will be self-recorded (in count).

  7. Secondary musculoskeletal complaints

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Lower extremity pain or injuries (other than patellofemoral pain) sustained during the race will be self-recorded (in count).

  8. Return to running readiness

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Perceived readiness to return to competitive running will be assessed on a 5-point Likert scale (not at all, slightly, moderately, very, or extremely).

  9. Barriers and facilitators (confidence in self-management)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Confidence in self-management ("I am confident in my ability to manage my symptoms and treatment plan on my own") will be measured using a 5-point Likert scale (strongly disagree, disagree, neither, agree, strongly agree).

  10. Barriers and facilitators (usability of the education platform)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Usability of the education platform ("The web-based education platform is easy to use and navigate") will be measured using a 5-point Likert scale (strongly disagree, disagree, neither, agree, strongly agree).

  11. Barriers and facilitators (treatment expectations)

    Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon

    Treatment expectations ("I believe that the web-based education and exercise program will help improve my condition") will be measured using a 5-point Likert scale (strongly disagree, disagree, neither, agree, strongly agree).

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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