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Patellofemoral PainNCT07266922

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

A study testing Education Platform-MyKneeCap.com in people with Patellofemoral Pain, run by Boston Children's Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Patellofemoral Pain
What is being tested?
Education Platform-MyKneeCap.com
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteUnited States
Study dates
20 Feb 2026to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Boston Children's Hospital

    Waltham, Massachusetts, 02453

Other trials in United States

About this study

Official title: 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.

Being tested
Education Platform-MyKneeCap.com
Keywords
Anterior knee pain, Patient education
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education Platform-MyKneeCap.comBehavioural

    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.

Study groups in NCT07266922
Study groupRoleWhat they receive
Pre-Marathon EducationExperimentalThis 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.
Receives: Behavioral: Education Platform-MyKneeCap.com
Wait-and-See Control / Post-Marathon EducationOtherThis 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.
Receives: Behavioral: Education Platform-MyKneeCap.com

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (11)
  1. Psychological function (fear-avoidance beliefs)

    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.

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

  2. Psychological function (pain self-efficacy)

    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.

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

  3. Patient satisfaction

    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).

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

  4. Marathon performance (finish time)

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

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

  5. Marathon performance (division ranking)

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

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

  6. Medical service use

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

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

  7. Secondary musculoskeletal complaints

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

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

  8. Return to running readiness

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

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

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

    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).

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

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

    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).

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

  11. Barriers and facilitators (treatment expectations)

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start20 Feb 2026
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07266922
Sponsor's protocol ID
IRB-P00052732
Status last verified
Mar 2026
First submitted
19 Nov 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 19229444
  • Evans JD. Straightforward statistics for the behavioral sciences. Thomson Brooks/Cole Publishing Co; 1996

  • Cohen J. Statistical power analysis for the behavioral sciences. Academic press; 1988

  • 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.

    PubMed 34965513
  • Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.

    PubMed 19261899
  • 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.

    PubMed 34972490
  • Asghari A, Nicholas MK. Pain self-efficacy beliefs and pain behaviour. A prospective study. Pain. 2001 Oct;94(1):85-100. doi: 10.1016/S0304-3959(01)00344-X.

    PubMed 11576748
  • 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.

    PubMed 19236982
  • 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.

    PubMed 16446108
  • Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

    PubMed 8455963
  • 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.

    PubMed 20046623
  • 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.

    PubMed 28258176
  • Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.

    PubMed 15129407
  • 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.

    PubMed 40716116
  • 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.

    PubMed 31055059

Questions about this trial

What is this clinical trial studying?

A study testing Education Platform-MyKneeCap.com in people with Patellofemoral Pain, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical outcomes (pain) (time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07266922, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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