Universidad de Oviedo
Oviedo, Principality of Asturias, 33006, Spain
NCT Number: NCT07408700
Background. Patellofemoral pain (PFP) is one of the most common causes of knee pain in recreational runners and is exacerbated by activities that load the patellofemoral joint. Although biomechanical differences between running surfaces and elevation profiles have been documented, the influence of terrain type and training load on PFP in non-professional runners remains poorly defined.
Objective. To examine the association between predominant training terrain and the presence of PFP in non-professional runners, and to describe its functional severity. Secondarily, to analyze the relationship between terrain exposure, elevation, training load and volume with PFP, as well as the potential influence of previous knee history and footwear rotation.
Methods. An observational, analytical, cross-sectional study conducted through an online survey targeting recreational runners. The primary outcome will be the presence of patellofemoral pain, defined according to the 2016 International Consensus, and functional severity will be assessed using the Spanish-validated Kujala Anterior Knee Pain Scale. Exposures will include the percentage of kilometers run on each terrain type, positive and negative elevation gain, internal load (session rating of perceived exertion × duration), training volume, and running pace. Potential confounders will include age, sex, body mass index, running experience, training frequency, previous knee history, lower-limb strength, accumulated elevation gain, and footwear rotation. Descriptive analyses and logistic regression models will be performed to identify independent associations.
Expected results. To estimate the prevalence of PFP in recreational runners, identify terrain- and load-related factors associated with its occurrence, and define a predictive model to inform prevention strategies and training planning.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Oviedo, Principality of Asturias, 33006, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Runners with lower or different exposure to these factors: other predominant terrain types (e.g., asphalt or trail), lower accumulated elevation gain, and/or lower levels of internal load and training volume.
Time frame: Screening visit
This variable will be defined according to the International Consensus on Patellofemoral Pain. Participants will be classified as positive cases if they report anterior or retropatellar knee pain in the previous three months, exacerbated by at least one weight-bearing, knee-flexion activity (e.g., running, stair ambulation, slopes, or squatting), with a duration of ≥4 weeks or ≥2 episodes during that period
Time frame: Screening visit
Functional severity will be assessed using the Spanish-validated version of the Kujala Anterior Knee Pain Scale. This is a condition-specific 13-item questionnaire that evaluates functional limitations, symptoms, and the ability to perform knee-loading activities. Total scores range from 0 to 100, with higher scores indicating better function and, therefore, lower severity.
Time frame: Screening visit
This variable will capture the type of terrain on which the runner habitually trains (asphalt, trail, and mountain). Participants will report the approximate percentage of total kilometers completed on asphalt, trail, and mountain terrain over the previous three months.
Time frame: Screening visit
This variable will be recorded as an average value (meters per week, or normalized as meters per 10 km), given that eccentric loading and patellofemoral joint stress increase substantially during prolonged downhill running.
Time frame: Screening visit
If mountain terrain is predominant, an additional item will be included to capture the percentage of kilometers run on downhills with a gradient ≥6%.
Time frame: Screening visit
Training intensity will be assessed using Foster's session Rating of Perceived Exertion (sRPE), based on the Borg CR-10 scale (0-10). Participants will report their mean perceived exertion for each session type (e.g., easy runs, intervals, hill sessions) over the previous four weeks. Weekly internal load will be calculated by multiplying the sRPE value by session duration (minutes).
Time frame: Screening visit
This variable will include weekly running distance (kilometers), training frequency (number of sessions per week), and session duration (minutes per session).
Time frame: Screening visit
This variable will be recorded as minutes per kilometer (min/km).
Time frame: Screening visit
This potential confounding or moderating variable will be measured in years.
Time frame: Screening visit
This potential confounding or moderating variable will be recorded as a dichotomous variable (female/male).
Time frame: Screening visit
This potential confounding or moderating variable will be calculated as kg/m².
Time frame: Screening visit
This potential confounding or moderating variable will be assessed as a dichotomous variable by asking: "Have you experienced knee pain or injury in the past 24 months?" (yes/no).
Time frame: Screening visit
This potential confounding or moderating variable will be measured as the number of years of running.
Time frame: Screening visit
This potential confounding or moderating variable will be recorded as the number of training sessions per week.
Time frame: Screening visit
This potential confounding or moderating variable will be measured as the total elevation gain per week.
Time frame: Screening visit
This potential confounding or moderating variable will be measured as the number of days per week dedicated to lower-limb and core strength exercises.
Time frame: Screening visit
This potential confounding or moderating variable will be assessed as a dichotomous variable indicating the use of two or more pairs of running shoes in rotation (yes/no).
University of Oviedo
Other
Influence of Training Surface and Mechanical Load on the Prevalence of Patellofemoral Pain in Recreational Runners: A Cross-Sectional Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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