Recruiting

CPG-Adherent Therapy

Sponsor:

Sara Gorczynski, PT, DPT

Code:

NCT06665204

Conditions

Patellofemoral Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Practice Guideline-adherent Care

Usual Care

Study Details

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.

Conditions

Patellofemoral Pain

Study ID

NCT06665204

Start date

Aug 22, 2025

Status verified date

Apr, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinical Practice Guideline-adherent Care

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.

active comparator: Usual Care

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.

Interventions

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.

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.

Primary outcome measure

  • Anterior Knee Pain Scale (AKPS) [ Time Frame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 6-weeks, 3-months (primary endpoint), 6-months, and 12-months post-randomization ]

Central Contacts and Locations

Central contacts

Sara R Gorczynski, PT, DPT

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

Shanmugasundaram Natesan, PhD

shanmugasundaram.natesan.civ@health.mil

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Sara Gorczynski, DPT

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

Shanmugasundaram Natesan, PhD

shanmugasundaram.natesan.civ@health.mil

More Information

Sponsor

Sara Gorczynski, PT, DPT

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sara Gorczynski, PT, DPT on 2026-05-06.