About this trial
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. Can a CPG-adherent care approach to PFP management improve short- and long-term knee function, pain, and confidence with completing duty-related activities? 2. Can a CPG-adherent care approach to PFP management reduce utilization of healthcare resources and analgesic medication prescription at 12-month follow-up? 3. 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Clinical Practice Guideline-adherent Care
- Usual Care
Treatment groups
Sponsors and collaborators
Sara Gorczynski, PT, DPT
Lead sponsor
United States Naval Medical Center, San Diego
Sponsor institution
Brooke Army Medical Center
Collaborator
Womack Army Medical Center
Collaborator
University of Pittsburgh
Collaborator
Chapman University
Collaborator
The Geneva Foundation
Collaborator
Naval Hospital Camp Pendleton
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator