Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSara Gorczynski, PT, DPT

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

440 Participants
are divided into 2 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