Enrolling by invitation NCT07266922
A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Education Platform-MyKneeCap.com.
- Who it may be relevant to
- Registry conditions: Patellofemoral Pain. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Running Informed, Not Just Trained: A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain
Overview
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
- Behavioral Education 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.
Primary outcome measures
- Clinical outcomes (pain) [Time frame: 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]
- Clinical outcomes (global rating of change) [Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon]
Secondary outcome measures (11)
- Psychological function (fear-avoidance beliefs) [Time frame: 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]
- Patient satisfaction [Time frame: 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]
- Marathon performance (division ranking) [Time frame: 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]
- Secondary musculoskeletal complaints [Time frame: 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]
- 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]
- 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]
- Barriers and facilitators (treatment expectations) [Time frame: 6-weeks leading up to the Boston Marathon, or 6-weeks post completion of Boston Marathon]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Waltham
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 19236982
Identifiers
NCT: NCT07266922 · IRB-P00052732