Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain

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. 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.

Conditions

• Patellofemoral Pain

Interventions

OTHER

Clinical Practice Guideline-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.

OTHER

Usual 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.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• Womack Army Medical Center

  collaborator FED

• University of Pittsburgh

  collaborator OTHER

• Chapman University

  collaborator OTHER

• The Geneva Foundation

  collaborator OTHER

• Naval Hospital Camp Pendleton

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• Sara Gorczynski, PT, DPT

  lead FED

Principal Investigators

• Shanmugasundaram R Natesan, PhD · United States Naval Medical Center, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-22

Primary Completion

2027-09-29

Completion

2028-09-29

Countries

• United States

Study Locations