Patellofemoral PainknEE-CAPPNCT06665204
Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain
A study testing Clinical Practice Guideline-adherent Care in people with Patellofemoral Pain, run by Sara Gorczynski, PT, DPT at 1 site in United States.
Trial summary
The overall goal of this multisite, randomized clinical trial is to evaluate the short- and long-term effectiveness of a Clinical Practice Guideline (CPG)-adherent physical therapy approach to patellofemoral pain (PFP) management among military Service members. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain
- What is being tested?
- Clinical Practice Guideline-adherent Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 29 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active-duty Service member
- Aged ≥18 years
- Presence of unilateral or bilateral PFP based on the core criterion of peripatellar and/or retropatellar pain with reproduction of PFP by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee, such as prolonged sitting, kneeling, squatting, hopping, running, stair climbing, patellar palpation
- Available to participate in physical therapy treatment within 6 weeks of initial enrollment
Who cannot join
- Presence of tibiofemoral OA based on imaging evidence in the electronic health records in the past year or self-report
- History of patellar or intra-articular knee trauma (e.g., dislocation/fracture) or surgery
- History of neurodegenerative conditions that may affect movement patterns (e.g., Multiple Sclerosis)
- Meniscal or ligamentous pathologies within the past year based on imaging evidence of acute injury in the electronic health record or self-report
- Quadriceps or patellar tendon injuries within the past year based on imaging evidence of acute injury in the electronic health record or self-report
- Known pregnancy (pregnant females may be eligible for participation after end of pregnancy and medical clearance by a qualified and licensed healthcare provider)
- Receipt of physical therapy care for PFP within the three months prior to enrollment
- Known to be pending medical evaluation board, discharge from the military, scheduled deployment, or litigation for an injury at time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shanmugasundaram Natesan, PhD contact
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
Sara Gorczynski, DPT, 619-532-9704, sara.r.gorczynski.ctr@health.mil
Shanmugasundaram Natesan, PhD, shanmugasundaram.natesan.civ@health.mil
About this study
Official title: Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP)
The overall goal of this multisite, randomized clinical trial is to evaluate the short- and long-term effectiveness of a Clinical Practice Guideline (CPG)-adherent physical therapy approach to patellofemoral pain (PFP) management among military Service members. The main questions it aims to answer are:
- Can a CPG-adherent care approach to PFP management improve short- and long-term knee function, pain, and confidence with completing duty-related activities?
- Can a CPG-adherent care approach to PFP management reduce utilization of healthcare resources and analgesic medication prescription at 12-month follow-up?
- Are there patient- and care-specific factors that predict or mediate clinical benefit from physical therapy care for PFP?
Read more
Researchers will compare the CPG-adherent physical therapy intervention to usual physical therapy care in the Military Health System.
Participants will: 1) be randomized to receive CPG-adherent care or usual care for PFP management; 2) attend physical therapy corresponding to their group assignment; and 3) complete patient-reported outcome measures at baseline and 6-weeks and 3-, 6-, and 12-months post-randomization.
Read the detailed description
Knee injuries are among the most common musculoskeletal injuries affecting military personnel, accounting for 22% of limited duty profiles and an average of 53 limited duty days per injury in 2017 alone. Patellofemoral pain (PFP) is the most prevalent knee injury affecting Service members but has historically been considered an innocuous and self-limiting condition despite its high rate of persistence. Physical therapy is often the first line-of-defense for PFP management. Published data support the notion that adherence to evidence-based Clinical Practice Guidelines (CPG) improves outcomes 1) for patients, via greater improvements in pain and disability; 2) for providers, by supporting clinical decision making and practice efficiency; and 3) for healthcare systems, by reducing length of treatment, resource utilization, and costs. In 2019, the American Physical Therapy Association (APTA) published its first CPG for PFP management to better enable physical therapists to make evidence-based treatment decisions; however, there is limited evidence regarding the effectiveness of a collective, standardized CPG-adherent approach in clinical care. To evaluate whether patients with PFP who receive CPG-adherent care demonstrate superior outcomes as compared to patients receiving the current usual care, we will compare: (1) CPG-adherent care (intervention arm), wherein physical therapy care is provided according to the CPG "Decision Tree" recommendations for PFP management, to (2) Usual Care (UC; comparator arm), wherein care decisions are made by non-research physical therapists in alignment with current organizational and clinical practice standards in the Military Health System (MHS). This multisite, single-blind randomized controlled trial will include 440 active-duty Service members with PFP across four major MHS physical therapy facilities (i.e., Naval Medical Center San Diego, Naval Hospital Camp Pendleton, Brooke Army Medical Center, and Womack Army Medical Center). The sample will include Service members from the Army, Navy, and Marines, as well as both conventional and special operations forces. The co-primary outcomes include changes in two CPG-recommended outcome measures [Anterior Knee Pain Scale (AKPS) and the Numeric Pain Rating Scale (NPRS)]. Outcomes will be assessed at baseline; 6-weeks post-randomization; and 3-, 6-, and 12-months post-randomization (primary endpoint: 3-months). Secondary outcomes will include between-group differences in confidence with completing duty-related tasks and 12-month analgesic medication prescription and PFP-specific medical resource utilization. An exploratory analysis will seek to determine the predictors and mediators of clinical benefit from physical therapy care for Service members with PFP. Baseline and follow-up assessments will be administered remotely to maximize participant reach and retention. The intervention of interest, CPG-adherent care, is designed to be clinically feasible, with high potential for clinician adoption, which may improve care quality and patient outcomes for Service members with PFP. Long-term, findings from this study have the potential to improve patient care for PFP and other musculoskeletal injury conditions across the MHS by demonstrating the feasibility and positive impact of CPG-adherent care, particularly in terms of improving clinical outcomes and resource utilization and reducing unwanted variability in rehabilitation.
- Conditions
- Patellofemoral Pain
- Being tested
- Clinical Practice Guideline-adherent Care, Usual Care
- Keywords
- Physical Therapy, Military, Service members, Rehabilitation, Clinical Practice Guidelines
- 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.
Clinical Practice Guideline-adherent CareOther
Also called CPG-adherent Care
Clinical examination procedures will be used to identify all appropriate impairment subcategories (Overuse/Overload without Other Impairment, PFP with Movement Coordination Deficits, PFP with Muscle Performance Deficits, PFP with Mobility Impairments) and create a subcategory-specific or multimodal (for patients classified to >1 subcategory) plan of care. Research physical therapists will target all applicable impairment subcategories using the corresponding CPG-recommended interventions, all of which are recommended for use as part of standard-of-care physical therapy practice. The duration and length of care will not be prespecified or standardized across participants to allow flexibility pending participant's care needs and schedule (e.g., vacation, short-term TDY status); however, research PTs will be trained to target providing no more than 10-12 visits over no more than 6-8 weeks to promote generalizability of the CPG-adherent intervention.
Usual CareOther
Also called Usual physical therapy care
Usual physical therapy care will be provided by a licensed outpatient staff physical therapist who is not associated with the research team. The outpatient physical therapists will not treat participants in the CPG-adherent group and will be free to treat their participants based on their current personal and organizational clinical practice standards. The research team will neither influence nor restrict the evaluations conducted or interventions provided.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Practice Guideline-adherent Care | Experimental | Participants randomized to receive CPG-adherent care will first receive a comprehensive clinical examination following the PFP CPG Decision Tree guidelines. Their treatment plan of care will correspond to any and all impairment subcategories, as defined by the PFP CPG. Receives: Other: Clinical Practice Guideline-adherent Care |
| Usual Care | Active comparator | All participants randomized to the UC group will receive routine physical therapy evaluations and treatments in the outpatient physical therapy clinics at each participating military treatment facility, at the discretion of the staff physical therapist. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Knee Pain Scale (AKPS)
The AKPS is a CPG-recommended, 13-item questionnaire assessing knee function in people with PFP, with items differentially weighted for a maximum score of 100 and higher scores indicating better function.
Measured: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
Numeric Pain Rating Scale (NPRS)
The 11-point NPRS is a CPG-recommended measure of pain intensity in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain).24-26 Average pain intensity in the past week will be assessed as part of the 3-item PEG, which includes 1-item each regarding average pain intensity, pain interference with enjoyment of life, and impact of pain on general activity.
Measured: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
Secondary outcomes (3)
Perceived Duty-related Confidence
Perceived confidence with completing duty-related activities will be evaluated using four questions assessing confidence with and perceived ability to perform military-related tasks, two of which are pulled from the Military Orthopedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab questionnaire.
Measured: 6-weeks, 3-months, 6-months, and 12-months post-randomization
12-month Healthcare Utilization
We will use individual electronic health record reviews alongside readily available EHR data elements indexed within Military Health System databases to determine the type and frequency of services received related to knee care during the 12 months following randomization. All medical resource utilization data will be identified and categorized using Healthcare Common Procedure Coding System (HCPCS) Level 1 current procedural terminology (CPT) 4 and 2 codes, International Classification of Disease, 10th Revision (ICD-10) codes, Medical Expense and Performance Reporting System (MEPRS) codes, and/or Health Insurance Privacy Authorization Act (HIPAA) taxonomy numbers. The categories that will be compared include: 1) visits to specialist clinics (e.g., sports medicine, orthopedists, physiatrists, pain management) and other health care providers, 2) diagnostic tests (e.g., x-rays, magnetic resonance imaging), and 3) surgical procedures.
Measured: 12-months post-randomization
12-month Analgesic Prescription
Medication prescription will be queried using the Pharmacy Data Transaction Service. All medications prescribed to each patient during the 12-month follow-up period (beginning with randomization) will be reviewed. For those identified as analgesics, details such as product name, therapeutic and generic classes, number of days' supply, fill date, and dosage will be extracted to characterize the total number of unique analgesic prescriptions, total days' supply, and days to last prescription during the surveillance period.
Measured: 12-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start22 Aug 2025
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon completing the informed consent, eligible participants will complete baseline questionnaires, then be randomized to 1) a CPG-adherent (intervention) arm in which PFP care is provided by research physical therapists based on CPG recommendations, and 2) a UC (comparator) arm, in which management decisions are made by non-research physical therapists in alignment with their personal and organizational practice standards but with no specific directives from the research team.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Gorczynski, PT, DPT
- Sponsor type
- US federal agency
- Collaborators
- Brooke Army Medical Center, Womack Army Medical Center, University of Pittsburgh, Chapman University, The Geneva Foundation, Naval Hospital Camp Pendleton, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor-investigator, Sara Gorczynski, PT, DPT, United States Naval Medical Center, San Diego
- Investigators
- Shanmugasundaram R Natesan, PhD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665204
- Sponsor's protocol ID
- NMCSD.2024.0040
- Other IDs
- CDMRP-OR230100
- Acronym
- knEE-CAPP
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final trial dataset will be made available to the research community upon request to and review by the Leadership Team. Data sharing agreements will be established to document the conditions for research use, privacy and confidentiality standards at the recipient site, and prohibitions for manipulating data for the purposes of identifying individuals. The final trial dataset will include all coded participant data (i.e., data that is de-identified by use of a unique study identification variable, with removal or modification of all identifiers). Individual-level data will include all screening information, baseline measures, intervention information, and primary and secondary outcomes. All SAS datasets will be supplied via secure transfer with the study protocol and data documentation (procedures used to collect the data, details about codes, variable definitions, variable field location, and type of variable).
Publications
Beisheim-Ryan EH, Mauntel TC, Rhon DI, Patterson CG, Parsons N, Paradise S, Roach MH, Pontillo M, Gorczynski SR, Emory A, Farrokhi S. Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP): Protocol for a Multisite, Parallel-Arm Randomized Clinical Trial in the Military Health System. Phys Ther. 2025 Nov 29;105(12):pzaf138. doi: 10.1093/ptj/pzaf138.
PubMed 41273076
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP)
- ClinicalTrials.gov ID
- NCT06665204
- Acronym / sponsor ID
- knEE-CAPP / NMCSD.2024.0040
- Conditions
- Patellofemoral Pain
- Keywords
- Physical Therapy, Military, Service members, Rehabilitation, Clinical Practice Guidelines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sara Gorczynski, PT, DPTUS federal agency
- Collaborators
- Brooke Army Medical Center, Womack Army Medical Center, University of Pittsburgh, Chapman University, The Geneva Foundation, Naval Hospital Camp Pendleton, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 30 Oct 2024 (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.
The overall goal of this multisite, randomized clinical trial is to evaluate the short- and long-term effectiveness of a Clinical Practice Guideline (CPG)-adherent physical therapy approach to patellofemoral pain (PFP) management among military Service members. The main questions it aims to answer are:
- Can a CPG-adherent care approach to PFP management improve short- and long-term knee function, pain, and confidence with completing duty-related activities?
- Can a CPG-adherent care approach to PFP management reduce utilization of healthcare resources and analgesic medication prescription at 12-month follow-up?
- Are there patient- and care-specific factors that predict or mediate clinical benefit from physical therapy care for PFP?
Researchers will compare the CPG-adherent physical therapy intervention to usual physical therapy care in the Military Health System.
Participants will: 1) be randomized to receive CPG-adherent care or usual care for PFP management; 2) attend physical therapy corresponding to their group assignment; and 3) complete patient-reported outcome measures at baseline and 6-weeks and 3-, 6-, and 12-months post-randomization.
Detailed description
Knee injuries are among the most common musculoskeletal injuries affecting military personnel, accounting for 22% of limited duty profiles and an average of 53 limited duty days per injury in 2017 alone. Patellofemoral pain (PFP) is the most prevalent knee injury affecting Service members but has historically been considered an innocuous and self-limiting condition despite its high rate of persistence. Physical therapy is often the first line-of-defense for PFP management. Published data support the notion that adherence to evidence-based Clinical Practice Guidelines (CPG) improves outcomes 1) for patients, via greater improvements in pain and disability; 2) for providers, by supporting clinical decision making and practice efficiency; and 3) for healthcare systems, by reducing length of treatment, resource utilization, and costs. In 2019, the American Physical Therapy Association (APTA) published its first CPG for PFP management to better enable physical therapists to make evidence-based treatment decisions; however, there is limited evidence regarding the effectiveness of a collective, standardized CPG-adherent approach in clinical care. To evaluate whether patients with PFP who receive CPG-adherent care demonstrate superior outcomes as compared to patients receiving the current usual care, we will compare: (1) CPG-adherent care (intervention arm), wherein physical therapy care is provided according to the CPG "Decision Tree" recommendations for PFP management, to (2) Usual Care (UC; comparator arm), wherein care decisions are made by non-research physical therapists in alignment with current organizational and clinical practice standards in the Military Health System (MHS). This multisite, single-blind randomized controlled trial will include 440 active-duty Service members with PFP across four major MHS physical therapy facilities (i.e., Naval Medical Center San Diego, Naval Hospital Camp Pendleton, Brooke Army Medical Center, and Womack Army Medical Center). The sample will include Service members from the Army, Navy, and Marines, as well as both conventional and special operations forces. The co-primary outcomes include changes in two CPG-recommended outcome measures [Anterior Knee Pain Scale (AKPS) and the Numeric Pain Rating Scale (NPRS)]. Outcomes will be assessed at baseline; 6-weeks post-randomization; and 3-, 6-, and 12-months post-randomization (primary endpoint: 3-months). Secondary outcomes will include between-group differences in confidence with completing duty-related tasks and 12-month analgesic medication prescription and PFP-specific medical resource utilization. An exploratory analysis will seek to determine the predictors and mediators of clinical benefit from physical therapy care for Service members with PFP. Baseline and follow-up assessments will be administered remotely to maximize participant reach and retention. The intervention of interest, CPG-adherent care, is designed to be clinically feasible, with high potential for clinician adoption, which may improve care quality and patient outcomes for Service members with PFP. Long-term, findings from this study have the potential to improve patient care for PFP and other musculoskeletal injury conditions across the MHS by demonstrating the feasibility and positive impact of CPG-adherent care, particularly in terms of improving clinical outcomes and resource utilization and reducing unwanted variability in rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Upon completing the informed consent, eligible participants will complete baseline questionnaires, then be randomized to 1) a CPG-adherent (intervention) arm in which PFP care is provided by research physical therapists based on CPG recommendations, and 2) a UC (comparator) arm, in which management decisions are made by non-research physical therapists in alignment with their personal and organizational practice standards but with no specific directives from the research team.
| Arm | Type | Receives |
|---|---|---|
| Clinical Practice Guideline-adherent Care | Experimental | Other: Clinical Practice Guideline-adherent CareParticipants randomized to receive CPG-adherent care will first receive a comprehensive clinical examination following the PFP CPG Decision Tree guidelines. Their treatment plan of care will correspond to any and all impairment subcategories, as defined by the PFP CPG. |
| Usual Care | Active comparator | Other: Usual CareAll participants randomized to the UC group will receive routine physical therapy evaluations and treatments in the outpatient physical therapy clinics at each participating military treatment facility, at the discretion of the staff physical therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active-duty Service member
- Aged ≥18 years
- Presence of unilateral or bilateral PFP based on the core criterion of peripatellar and/or retropatellar pain with reproduction of PFP by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee, such as prolonged sitting, kneeling, squatting, hopping, running, stair climbing, patellar palpation
- Available to participate in physical therapy treatment within 6 weeks of initial enrollment
Key exclusion criteria (8 listed)
- Presence of tibiofemoral OA based on imaging evidence in the electronic health records in the past year or self-report
- History of patellar or intra-articular knee trauma (e.g., dislocation/fracture) or surgery
- History of neurodegenerative conditions that may affect movement patterns (e.g., Multiple Sclerosis)
- Meniscal or ligamentous pathologies within the past year based on imaging evidence of acute injury in the electronic health record or self-report
- Quadriceps or patellar tendon injuries within the past year based on imaging evidence of acute injury in the electronic health record or self-report
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 |
|---|---|---|
| Clinical Practice Guideline-adherent CareAlso: CPG-adherent CareClinical examination procedures will be used to identify all appropriate impairment subcategories (Overuse/Overload without Other Impairment, PFP with Movement Coordination Deficits, PFP with Muscle Performance Deficits, PFP with Mobility Impairments) and create a subcategory-specific or multimodal (for patients classified to >1 subcategory) plan of care. Research physical therapists will target all applicable impairment subcategories using the corresponding CPG-recommended interventions, all of which are recommended for use as part of standard-of-care physical therapy practice. The duration and length of care will not be prespecified or standardized across participants to allow flexibility pending participant's care needs and schedule (e.g., vacation, short-term TDY status); however, research PTs will be trained to target providing no more than 10-12 visits over no more than 6-8 weeks to promote generalizability of the CPG-adherent intervention. | Other | Clinical Practice Guideline-adherent Care |
| Usual CareAlso: Usual physical therapy careUsual physical therapy care will be provided by a licensed outpatient staff physical therapist who is not associated with the research team. The outpatient physical therapists will not treat participants in the CPG-adherent group and will be free to treat their participants based on their current personal and organizational clinical practice standards. The research team will neither influence nor restrict the evaluations conducted or interventions provided. | Other | Usual Care |
Primary outcome
Anterior Knee Pain Scale (AKPS)
Time frame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
The AKPS is a CPG-recommended, 13-item questionnaire assessing knee function in people with PFP, with items differentially weighted for a maximum score of 100 and higher scores indicating better function.
Numeric Pain Rating Scale (NPRS)
Time frame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
The 11-point NPRS is a CPG-recommended measure of pain intensity in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain).24-26 Average pain intensity in the past week will be assessed as part of the 3-item PEG, which includes 1-item each regarding average pain intensity, pain interference with enjoyment of life, and impact of pain on general activity.
3 secondary outcomes
Perceived Duty-related Confidence
Time frame: 6-weeks, 3-months, 6-months, and 12-months post-randomization
12-month Healthcare Utilization
Time frame: 12-months post-randomization
12-month Analgesic Prescription
Time frame: 12-months post-randomization
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 6 May 2026.
- Derived from this study: PubMed 41273076Beisheim-Ryan EH, Mauntel TC, Rhon DI, Patterson CG, Parsons N, Paradise S, Roach MH, Pontillo M, Gorczynski SR, Emory A, Farrokhi S. Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP): Protocol for a Multisite, Parallel-Arm Randomized Clinical Trial in the Military Health System. Phys Ther. 2025 Nov 29;105(12):pzaf138. doi: 10.1093/ptj/pzaf138.
- Individual participant dataSharing planned: Yes. The final trial dataset will be made available to the research community upon request to and review by the Leadership Team. Data sharing agreements will be established to document the conditions for research use, privacy and confidentiality standards at the recipient site, and prohibitions for manipulating data for the purposes of identifying individuals. The final trial dataset will include all coded participant data (i.e., data that is de-identified by use of a unique study identification variable, with removal or modification of all identifiers). Individual-level data will include all screening information, baseline measures, intervention information, and primary and secondary outcomes. All SAS datasets will be supplied via secure transfer with the study protocol and data documentation (procedures used to collect the data, details about codes, variable definitions, variable field location, and type of variable).
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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.
Shanmugasundaram Natesan, PhD contact
Shanmugasundaram R Natesan, PhD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Practice Guideline-adherent Care in people with Patellofemoral Pain, run by Sara Gorczynski, PT, DPT 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 8 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: looking for participants now, as of the sponsor's last update on 6 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 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?
Contact Sara R Gorczynski, PT, DPT (619-532-9704, sara.r.gorczynski.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Knee Pain Scale (AKPS) (time frame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization). The study lists 2 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 NCT06665204, which also lists 1 linked publication.
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 6 May 2026.