Patello Femoral Pain SyndromeNCT07408700
Influence of Training Surface and Mechanical Load on the Prevalence of Patellofemoral Pain in Recreational Runners
An observational study of Patello Femoral Pain Syndrome, run by University of Oviedo at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patello Femoral Pain Syndrome
- What is being tested?
- Runner sample
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2026to 11 May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult non-professional / recreational runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain.
Who may be able to join
- Participants aged 18 years or older.
- Recreational (non-professional) runners.
- Have run regularly over the previous 3 months (at least once per week).
- Are able to report their predominant training terrain (asphalt, trail, or mountain).
- Have or do not have patellofemoral pain.
- Have provided written informed consent.
Who cannot join
- Have had a complete cessation of running for ≥4 weeks within the previous 3 months.
- Have undergone major knee or ankle surgery within the past year.
- Have a diagnosis of conditions that clearly alter gait or running pattern.
- Present severe knee disorders that preclude accurate assessment of patellofemoral pain.
- Have incomplete questionnaires for essential variables (terrain type, patellofemoral pain, AKPS, training load, or training volume)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Training Surface and Mechanical Load on the Prevalence of Patellofemoral Pain in Recreational Runners: A Cross-Sectional Cohort Study
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.
Read more
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.
- Conditions
- Patello Femoral Pain Syndrome
- Being tested
- Runner sample
- Keywords
- Patellofemoral Pain Syndrome, Running, Surfaces, Exercise, Workload, Epidemiology
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runner sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Non-professional / recreational adult runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain. Receives: Other: Runner sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of patellofemoral pain over the previous three months.
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
Measured: Screening visit
Secondary outcomes (7)
Measurement of functional severity of patellofemoral pain
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.
Measured: Screening visit
Measurement of terrain exposure (previous 3 months)
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.
Measured: Screening visit
Measurement of weekly positive and negative elevation gain
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.
Measured: Screening visit
Measurement of the percentage of downhill kilometers
If mountain terrain is predominant, an additional item will be included to capture the percentage of kilometers run on downhills with a gradient ≥6%.
Measured: Screening visit
Measurement of training intensity and internal load (previous 4 weeks)
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).
Measured: Screening visit
Measurement of training volume over the previous 4 weeks
This variable will include weekly running distance (kilometers), training frequency (number of sessions per week), and session duration (minutes per session).
Measured: Screening visit
Measurement of mean running pace over the previous 4 weeks
This variable will be recorded as minutes per kilometer (min/km).
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start12 Feb 2026
- Primary completion3 Apr 2026
- Study completion11 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patello Femoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408700
- Sponsor's protocol ID
- Correc
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Training Surface and Mechanical Load on the Prevalence of Patellofemoral Pain in Recreational Runners: A Cross-Sectional Cohort Study
- ClinicalTrials.gov ID
- NCT07408700
- Acronym / sponsor ID
- Correc
- Conditions
- Patello Femoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, Running, Surfaces, Exercise, Workload, Epidemiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 11 May 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Runner sampleNon-professional / recreational adult runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult non-professional / recreational runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain.
Key inclusion criteria (6 listed)
- Participants aged 18 years or older.
- Recreational (non-professional) runners.
- Have run regularly over the previous 3 months (at least once per week).
- Are able to report their predominant training terrain (asphalt, trail, or mountain).
- Have or do not have patellofemoral pain.
Key exclusion criteria (5 listed)
- Have had a complete cessation of running for ≥4 weeks within the previous 3 months.
- Have undergone major knee or ankle surgery within the past year.
- Have a diagnosis of conditions that clearly alter gait or running pattern.
- Present severe knee disorders that preclude accurate assessment of patellofemoral pain.
- Have incomplete questionnaires for essential variables (terrain type, patellofemoral pain, AKPS, training load, or training volume)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Runner sampleRunners 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. | Other | Observational group |
Primary outcome
Measurement of patellofemoral pain over the previous three months.
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
7 secondary outcomes
Measurement of functional severity of patellofemoral pain
Time frame: Screening visit
Measurement of terrain exposure (previous 3 months)
Time frame: Screening visit
Measurement of weekly positive and negative elevation gain
Time frame: Screening visit
Measurement of the percentage of downhill kilometers
Time frame: Screening visit
Measurement of training intensity and internal load (previous 4 weeks)
Time frame: Screening visit
Measurement of training volume over the previous 4 weeks
Time frame: Screening visit
Measurement of mean running pace over the previous 4 weeks
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patello Femoral Pain Syndrome, run by University of Oviedo at 1 site in Spain.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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 Spain. 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?
Measurement of patellofemoral pain over the previous three months. (time frame: Screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.