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

NCT07266922 | Enrolling By Invitation

• 1 other identifier: IRB-P00052732
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patellofemoral Pain

Keywords

Anterior knee pain; Patient education

Outcome Measures

Primary Outcomes (3)

• Clinical outcomes (pain)

  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.

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

• Clinical outcomes (self-reported function)

  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.

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

• Clinical outcomes (global rating of change)

  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.

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

Secondary Outcomes (11)

• 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

Study Arms (2)

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.

Behavioral: Education Platform-MyKneeCap.com

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.

Behavioral: Education Platform-MyKneeCap.com

Interventions

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.

Pre-Marathon Education; Wait-and-See Control / Post-Marathon Education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Location

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MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Sungwan Kim, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will conduct a two-arm, parallel-group, single-blinded randomized controlled trial to evaluate the effect of the intervention prior to the marathon (Group 1: treatment vs. Group 2: wait-and-see control). After the marathon, Group 2 will receive the same intervention, and outcomes will be assessed in a quasi-experimental pre-post design (i.e., as a single treatment group).

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: February 20, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be analyzed for the manuscript, and all will be de-identified. This is approximately from the end of the study collection June 2026 to September 2026 for analysis.

Locations

US (1)