Evaluating the Effectiveness of Clinical Practice Guideline Adherence for Patellofemoral Pain

Conditions

• Patellofemoral Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 22, 2025

Status verified

Apr 2026

Primary completion

Sep 29, 2027

Completion

Sep 29, 2028

Study Design

Enrollment

440 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Sara R Gorczynski, PT, DPT
  619-532-9704
  [email protected]
• Shanmugasundaram Natesan, PhD
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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