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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07266922
Enrollment
104
Registered
2025-12-05
Start date
2026-02-20
Completion date
2026-07-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Pain

Keywords

Anterior knee pain, Patient education

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.

Interventions

BEHAVIORALEducation Platform-MyKneeCap.com

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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcomes (pain)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonPain 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)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonSelf-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)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonGlobal 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

MeasureTime frameDescription
Psychological function (fear-avoidance beliefs)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonFear-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.
Psychological function (pain self-efficacy)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonPain 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.
Patient satisfaction6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonSatisfaction 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).
Marathon performance (finish time)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonFinish time will be evaluated by comparing the official finish time to the participant's intended finish time (in minutes).
Marathon performance (division ranking)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonDivision ranking will be evaluated by comparing the division ranking to the participant's intended division ranking (in rank).
Medical service use6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonIntra-event medical encounters for knee pain will be self-recorded (in count).
Secondary musculoskeletal complaints6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonLower extremity pain or injuries (other than patellofemoral pain) sustained during the race will be self-recorded (in count).
Return to running readiness6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonPerceived readiness to return to competitive running will be assessed on a 5-point Likert scale (not at all, slightly, moderately, very, or extremely).
Barriers and facilitators (confidence in self-management)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonConfidence 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).
Barriers and facilitators (usability of the education platform)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonUsability 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).
Barriers and facilitators (treatment expectations)6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston MarathonTreatment 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSungwan Kim, PhD

Boston Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026