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.
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
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
Parallel
Clinical Practice Guideline-adherent Care
Other interventionClinical 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.
Usual Care
Other interventionUsual 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.
Anterior Knee Pain Scale (AKPS)
The AKPS is a CPG-recommended, 13-item questionnaire assessing knee function in people with PFP, with items differentially weighted for a maximum score of 100 and higher scores indicating better function.
Numeric Pain Rating Scale (NPRS)
The 11-point NPRS is a CPG-recommended measure of pain intensity in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain).24-26 Average pain intensity in the past week will be assessed as part of the 3-item PEG, which includes 1-item each regarding average pain intensity, pain interference with enjoyment of life, and impact of pain on general activity.
Perceived Duty-related Confidence
Perceived confidence with completing duty-related activities will be evaluated using four questions assessing confidence with and perceived ability to perform military-related tasks, two of which are pulled from the Military Orthopedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab questionnaire.
12-month Healthcare Utilization
We will use individual electronic health record reviews alongside readily available EHR data elements indexed within Military Health System databases to determine the type and frequency of services received related to knee care during the 12 months following randomization. All medical resource utilization data will be identified and categorized using Healthcare Common Procedure Coding System (HCPCS) Level 1 current procedural terminology (CPT) 4 and 2 codes, International Classification of Disease, 10th Revision (ICD-10) codes, Medical Expense and Performance Reporting System (MEPRS) codes, and/or Health Insurance Privacy Authorization Act (HIPAA) taxonomy numbers. The categories that will be compared include: 1) visits to specialist clinics (e.g., sports medicine, orthopedists, physiatrists, pain management) and other health care providers, 2) diagnostic tests (e.g., x-rays, magnetic resonance imaging), and 3) surgical procedures.
12-month Analgesic Prescription
Medication prescription will be queried using the Pharmacy Data Transaction Service. All medications prescribed to each patient during the 12-month follow-up period (beginning with randomization) will be reviewed. For those identified as analgesics, details such as product name, therapeutic and generic classes, number of days' supply, fill date, and dosage will be extracted to characterize the total number of unique analgesic prescriptions, total days' supply, and days to last prescription during the surveillance period.
Optimal Screening for Prediction of Referral and Outcome Yellow Flag Assessment Tool - 10-item (OSPRO-YF)
The Optimal Screening for Prediction of Referral and Outcome Yellow Flag (OSPRO-YF) Assessment Tool is a multidimensional psychological assessment tool that has been used to identify psychological phenotypes associated with pain-related health outcomes (e.g., functional disability, sleep disturbance, catastrophizing). The OSPRO-YF can accurately estimate patient scores on a variety of validated, full-length outcome measures assessing pain-related psychological function (e.g., Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia, Pain Self-efficacy Questionnaire) and identify whether scores reflect a "yellow flag" (i.e., surpass prognostic thresholds for development of disability after musculoskeletal pain onset).
Global Rating of Change (GROC)
Global Rating of Change (GROC) is a one-item, 15-point scale, that provides information about self-perceived improvement in a patient ranging from -7 (a very great deal worse) to +7 (a very great deal better) with 0 in the middle (about the same). Scores of +4 and +5 are indicative of moderate changes in status, while +6 and +7 are indicative of a large change in a person's status.
Patient-reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs)
The Physical Function and Pain Interference CATs will be included, which are intended for clinicians and researchers in various disciplines who are interested in measuring physical, mental, and social health among individuals with various chronic conditions. All PROMIS® scores are reported on a T-score metric, where T-score of 50 aligns with the general population mean (standard deviation: 10). Higher scores indicate more of the domain being assessed.
Pain Sensitivity Questionnaire
The Pain Sensitivity Questionnaire (PSQ)49 is designed to assess sensitivity to pain by asking participants to rate the pain intensity they would imagine experiencing in everyday pain-inducing scenarios. It includes 17 items rated from 0-10, where a score of '10' indicates the most painful sensation. The total score is calculated by summing each item with the exceptions of 5, 9, and 13 (as these situations do not reflect painful situations). The PSQ is a validated outcome measure that is predictive of sensitivity to experimental pain thresholds for mechanical, heat, and cold pain.
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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
