Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain

NCT06665204 | Recruiting DMC

• 2 other identifiers: NMCSD.2024.0040CDMRP-OR230100
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Are there patient- and care-specific factors that predict or mediate clinical benefit from physical therapy care for PFP?

Conditions

Patellofemoral Pain

Keywords

Physical Therapy; Military; Service members; Rehabilitation; Clinical Practice Guidelines

Outcome Measures

Primary Outcomes (2)

• 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.

  6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization

• 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.

  6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization

Secondary Outcomes (3)

• Perceived Duty-related Confidence

  6-weeks, 3-months, 6-months, and 12-months post-randomization

• 12-month Healthcare Utilization

  12-months post-randomization

• 12-month Analgesic Prescription

  12-months post-randomization

Other Outcomes (4)

• Optimal Screening for Prediction of Referral and Outcome Yellow Flag Assessment Tool - 10-item (OSPRO-YF)

  6-weeks and 3-months post-randomization

• Global Rating of Change (GROC)

  6-weeks, 3-months, 6-months, and 12-months post-randomization

• Patient-reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs)

  6-weeks, 3-months, 6-months, and 12-months post-randomization

Study Arms (2)

Clinical Practice Guideline-adherent Care

EXPERIMENTAL

Participants randomized to receive CPG-adherent care will first receive a comprehensive clinical examination following the PFP CPG Decision Tree guidelines. Their treatment plan of care will correspond to any and all impairment subcategories, as defined by the PFP CPG.

Other: Clinical Practice Guideline-adherent Care

Usual Care

ACTIVE COMPARATOR

All participants randomized to the UC group will receive routine physical therapy evaluations and treatments in the outpatient physical therapy clinics at each participating military treatment facility, at the discretion of the staff physical therapist.

Other: Usual Care

Interventions

Usual Care OTHER

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.

Also known as: Usual physical therapy care

Usual Care

Clinical Practice Guideline-adherent Care OTHER

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.

Also known as: CPG-adherent Care

Clinical Practice Guideline-adherent Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: collaborator
• Womack Army Medical Center: collaborator
• Chapman University: collaborator
• Sara Gorczynski, PT, DPT: lead
• University of Pittsburgh: collaborator
• The Geneva Foundation: collaborator
• Naval Hospital Camp Pendleton: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Shanmugasundaram R Natesan, PhD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara R Gorczynski, PT, DPT

CONTACT

619-532-9704; sara.r.gorczynski.ctr@health.mil

Shanmugasundaram Natesan, PhD

CONTACT

shanmugasundaram.natesan.civ@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Given the nature of the CPG-adherent and UC intervention arms, it is not possible to blind treating physical therapists to treatment assignments; however, study participants will be blinded to their group assignments. Research personnel will be trained to endorse clinical equipoise of the two intervention arms during the informed consent process to limit unintentional biases. Further, all baseline and follow-up assessments will be administered remotely and distributed by a research team member who was not present for the study intervention (i.e., physical therapy treatment), limiting the potential influence of unblinded assessors on the outcomes of the study. Research team members facilitating remote baseline and follow-up assessments will be instructed to not answer or provide any direct guidance regarding completion of patient-reported outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Physical Therapist

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: August 22, 2025
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 29, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Datasets will be available no later than the acceptance for publication of the primary and secondary findings from the final data set or one year after database lock.

Locations

US (1)