- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266922
A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain
March 6, 2026 updated by: Sungwan Kim, Boston Children's Hospital
Running Informed, Not Just Trained: 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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02453
- Boston Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre-Marathon Education
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.
|
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.
|
|
Other: Wait-and-See Control / Post-Marathon Education
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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.
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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.
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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.
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
|
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).
|
6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sungwan Kim, PhD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
- van Gent RN, Siem D, van Middelkoop M, van Os AG, Bierma-Zeinstra SM, Koes BW. Incidence and determinants of lower extremity running injuries in long distance runners: a systematic review. Br J Sports Med. 2007 Aug;41(8):469-80; discussion 480. doi: 10.1136/bjsm.2006.033548. Epub 2007 May 1.
- Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
- Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
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- Crossley KM, van Middelkoop M, Callaghan MJ, Collins NJ, Rathleff MS, Barton CJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 2: recommended physical interventions (exercise, taping, bracing, foot orthoses and combined interventions). Br J Sports Med. 2016 Jul;50(14):844-52. doi: 10.1136/bjsports-2016-096268. Epub 2016 May 31. No abstract available.
- Barton CJ, Lack S, Hemmings S, Tufail S, Morrissey D. The 'Best Practice Guide to Conservative Management of Patellofemoral Pain': incorporating level 1 evidence with expert clinical reasoning. Br J Sports Med. 2015 Jul;49(14):923-34. doi: 10.1136/bjsports-2014-093637. Epub 2015 Feb 25.
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- Piva SR, Fitzgerald GK, Irrgang JJ, Fritz JM, Wisniewski S, McGinty GT, Childs JD, Domenech MA, Jones S, Delitto A. Associates of physical function and pain in patients with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2009 Feb;90(2):285-95. doi: 10.1016/j.apmr.2008.08.214.
- Willy RW, Hoglund LT, Barton CJ, Bolgla LA, Scalzitti DA, Logerstedt DS, Lynch AD, Snyder-Mackler L, McDonough CM. Patellofemoral Pain. J Orthop Sports Phys Ther. 2019 Sep;49(9):CPG1-CPG95. doi: 10.2519/jospt.2019.0302.
- Crossley KM, Stefanik JJ, Selfe J, Collins NJ, Davis IS, Powers CM, McConnell J, Vicenzino B, Bazett-Jones DM, Esculier JF, Morrissey D, Callaghan MJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 1: Terminology, definitions, clinical examination, natural history, patellofemoral osteoarthritis and patient-reported outcome measures. Br J Sports Med. 2016 Jul;50(14):839-43. doi: 10.1136/bjsports-2016-096384. Epub 2016 Jun 24. No abstract available.
- Smith BE, Moffatt F, Hendrick P, Bateman M, Rathleff MS, Selfe J, Smith TO, Logan P. The experience of living with patellofemoral pain-loss, confusion and fear-avoidance: a UK qualitative study. BMJ Open. 2018 Jan 23;8(1):e018624. doi: 10.1136/bmjopen-2017-018624.
- McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.
- Maclachlan LR, Collins NJ, Matthews MLG, Hodges PW, Vicenzino B. The psychological features of patellofemoral pain: a systematic review. Br J Sports Med. 2017 May;51(9):732-742. doi: 10.1136/bjsports-2016-096705. Epub 2017 Mar 20.
- Piva SR, Gil AB, Moore CG, Fitzgerald GK. Responsiveness of the activities of daily living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain. J Rehabil Med. 2009 Feb;41(3):129-35. doi: 10.2340/16501977-0295.
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- Vicenzino BT, Rathleff MS, Holden S, Maclachlan L, Smith BE, de Oliveira Silva D, van Middelkoop M. Developing Clinical and Research Priorities for Pain and Psychological Features in People With Patellofemoral Pain: An International Consensus Process With Health Care Professionals. J Orthop Sports Phys Ther. 2022 Jan;52(1):29-39. doi: 10.2519/jospt.2022.10647.
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- Crossley KM, Macri EM, Cowan SM, Collins NJ, Roos EM. The patellofemoral pain and osteoarthritis subscale of the KOOS (KOOS-PF): development and validation using the COSMIN checklist. Br J Sports Med. 2018 Sep;52(17):1130-1136. doi: 10.1136/bjsports-2016-096776. Epub 2017 Mar 3.
- Souto LR, Pazzinatto MF, De Oliveira Silva D, Ezzat AM, Barton CJ. Self-directed versus supervised exercise therapy program combined with digitally supported patient education for knee osteoarthritis: a randomised, parallel-group feasibility trial. Semin Arthritis Rheum. 2025 Oct;74:152787. doi: 10.1016/j.semarthrit.2025.152787. Epub 2025 Jul 20.
- Barton CJ, de Oliveira Silva D, Patterson BE, Crossley KM, Pizzari T, Nunes GS. A proximal progressive resistance training program targeting strength and power is feasible in people with patellofemoral pain. Phys Ther Sport. 2019 Jul;38:59-65. doi: 10.1016/j.ptsp.2019.04.010. Epub 2019 May 2.
- Lack S, Neal B, De Oliveira Silva D, Barton C. How to manage patellofemoral pain - Understanding the multifactorial nature and treatment options. Phys Ther Sport. 2018 Jul;32:155-166. doi: 10.1016/j.ptsp.2018.04.010. Epub 2018 Apr 12.
- Liao TC, Keyak JH, Powers CM. Runners With Patellofemoral Pain Exhibit Greater Peak Patella Cartilage Stress Compared With Pain-Free Runners. J Appl Biomech. 2018 Aug 1;34(4):298-305. doi: 10.1123/jab.2017-0229. Epub 2018 Jul 11.
- Bazett-Jones DM, Cobb SC, Huddleston WE, O'Connor KM, Armstrong BS, Earl-Boehm JE. Effect of patellofemoral pain on strength and mechanics after an exhaustive run. Med Sci Sports Exerc. 2013 Jul;45(7):1331-9. doi: 10.1249/MSS.0b013e3182880019.
- Silva DDO, Pazzinatto M, Azevedo F, Crossley K, Barton C. Web-based multimedia education for people with patellofemoral pain: a preliminary analysis of a randomised controlled trial. J Sci Med Sport. 2018;21:S52-S53.
- De Oliveira Silva D, Pazzinatto MF, Crossley KM, Azevedo FM, Barton CJ. Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study. J Med Internet Res. 2020 Jul 22;22(7):e18584. doi: 10.2196/18584.
- Esculier JF, Maggs K, Maggs E, Dubois B. A Contemporary Approach to Patellofemoral Pain in Runners. J Athl Train. 2020 Nov 16;55(12):0. doi: 10.4085/1062-6050-0535.19.
- Feely C, Smyth B, Caulfield B, Lawlor A. Estimating the cost of training disruptions on marathon performance. Front Sports Act Living. 2023 Jan 10;4:1096124. doi: 10.3389/fspor.2022.1096124. eCollection 2022.
- Kim S, Wu Y, Glaviano NR, Pescatello LS. Physical Activity Levels in Persons With Patellofemoral Pain: A Systematic Review and Meta-analysis. Sports Health. 2025 Jul;17(4):804-814. doi: 10.1177/19417381241264494. Epub 2024 Aug 11.
- Glaviano NR, Holden S, Bazett-Jones DM, Singe SM, Rathleff MS. Living well (or not) with patellofemoral pain: A qualitative study. Phys Ther Sport. 2022 Jul;56:1-7. doi: 10.1016/j.ptsp.2022.05.011. Epub 2022 May 26.
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- Rathleff MS, Rathleff CR, Olesen JL, Rasmussen S, Roos EM. Is Knee Pain During Adolescence a Self-limiting Condition? Prognosis of Patellofemoral Pain and Other Types of Knee Pain. Am J Sports Med. 2016 May;44(5):1165-71. doi: 10.1177/0363546515622456. Epub 2016 Jan 20.
- Glaviano NR, Baellow A, Saliba S. Physical activity levels in individuals with and without patellofemoral pain. Phys Ther Sport. 2017 Sep;27:12-16. doi: 10.1016/j.ptsp.2017.07.002. Epub 2017 Jul 18.
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- Souto LR, De Oliveira Silva D, Pazzinatto MF, Barton CJ. Beliefs of People With Patellofemoral Pain About Their Condition and Treatments Before and After Self-Directed Access to a Web-Based Education Platform. Musculoskeletal Care. 2025 Sep;23(3):e70165. doi: 10.1002/msc.70165.
- de Oliveira Silva D, Pazzinatto MF, Rathleff MS, Holden S, Bell E, Azevedo F, Barton C. Patient Education for Patellofemoral Pain: A Systematic Review. J Orthop Sports Phys Ther. 2020 Jul;50(7):388-396. doi: 10.2519/jospt.2020.9400. Epub 2020 Apr 29.
- Rathleff MS, Thomsen JL, Barton CJ. Patient education in patellofemoral pain: potentially potent and essential, but under-researched. Br J Sports Med. 2018 May;52(10):623-624. doi: 10.1136/bjsports-2017-098298. Epub 2017 Sep 19. No abstract available.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
November 24, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00052732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that will be shared will be de-identified and for manuscript and publishing purposes only.
PHI data will not be accessible outside of the research team, and only de-identified data will be a part of the manuscript.
IPD Sharing 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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