Clinical trial NCT06665204: Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain
Official title: Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain (knEE-CAPP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patellofemoral Pain
Keywords: Physical Therapy
Military
Service members
Rehabilitation
Clinical Practice Guidelines
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Brooke Army Medical Center
name: Womack Army Medical Center
name: University of Pittsburgh
name: Chapman University
name: The Geneva Foundation
name: Naval Hospital Camp Pendleton
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2024-10-30
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Anterior Knee Pain Scale (AKPS)
timeFrame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization
Secondary outcomes:
measure: Perceived Duty-related Confidence
timeFrame: 6-weeks, 3-months, 6-months, and 12-months post-randomization
measure: 12-month Healthcare Utilization
timeFrame: 12-months post-randomization
measure: 12-month Analgesic Prescription
timeFrame: 12-months post-randomization
Other outcomes:
measure: Optimal Screening for Prediction of Referral and Outcome Yellow Flag Assessment Tool - 10-item (OSPRO-YF)
timeFrame: 6-weeks and 3-months post-randomization
measure: Global Rating of Change (GROC)
timeFrame: 6-weeks, 3-months, 6-months, and 12-months post-randomization
measure: Patient-reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs)
timeFrame: 6-weeks, 3-months, 6-months, and 12-months post-randomization
measure: Pain Sensitivity Questionnaire
timeFrame: 6-weeks, 3-months, 6-months, and 12-months post-randomization
Locations:
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Emma H Beisheim-Ryan, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: