Guideline-based physical therapy for patellofemoral pain
Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP)
This trial will test whether guideline-based physical therapy helps active-duty Service members with patellofemoral pain reduce pain, improve knee function, and feel more confident doing duty tasks compared with usual physical therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | United States Naval Medical Center, San Diego Federal |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06665204 on ClinicalTrials.gov |
What this trial studies
This is a multisite, randomized trial comparing Clinical Practice Guideline (CPG)-adherent physical therapy to usual physical therapy care for patellofemoral pain in the Military Health System. Participants who meet eligibility criteria are randomized to receive either CPG-directed care or usual care and complete short- and long-term follow-up visits and outcome measures. Primary outcomes include knee pain, function, and confidence with duty-related activities, and secondary outcomes include healthcare resource use and analgesic prescriptions at 12 months. The study will also analyze patient- and care-specific factors that might predict or mediate benefit from physical therapy.
Who should consider this trial
Good fit: Active-duty Service members age 18 or older with peripatellar or retropatellar pain reproduced by at least one weight-bearing activity and available to start physical therapy within six weeks are ideal candidates.
Not a fit: Patients with tibiofemoral osteoarthritis, prior patellar/intra-articular knee trauma or surgery, recent meniscal or ligamentous injury, or neurodegenerative conditions affecting movement are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, guideline-adherent care could lead to faster symptom improvement, better knee function, and reduced reliance on medications and healthcare resources for Service members with PFP.
How similar studies have performed: Prior research and guideline-based approaches have shown improved pain and function with evidence-based physical therapy, but few large randomized multisite trials have tested a standardized CPG-adherent program in military populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
San Diego, California
- Naval Medical Center San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Shanmugasundaram R Natesan, PhD — United States Naval Medical Center, San Diego
- Study coordinator: Sara R Gorczynski, PT, DPT
- Email: sara.r.gorczynski.ctr@health.mil
- Phone: 619-532-9704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.