440 Participants Needed

Guideline-Adherent Care for Knee Pain

(knEE-CAPP Trial)

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EH
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Overseen ByShanmugasundaram Natesan, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: United States Naval Medical Center, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific physical therapy approach can better manage knee pain in military Service members compared to regular care. The goal is to determine if this treatment improves knee function and reduces the need for pain medication over time. Participants will follow either a special guideline-based treatment (Clinical Practice Guideline-adherent Care) or standard physical therapy. Service members with ongoing knee pain during activities like sitting, squatting, or running might be suitable for this trial. As an unphased trial, this study offers Service members the chance to contribute to research that could enhance knee pain management strategies.

What prior data suggests that this Clinical Practice Guideline-adherent care is safe for managing patellofemoral pain?

Research shows that following specific guidelines for treating patellofemoral pain (pain around the kneecap) can lead to better results. These guidelines have improved care for people with knee problems, and evidence supports their effectiveness.

Physical therapy treatments are generally well-tolerated, with most people not experiencing serious side effects. The guidelines ensure consistent care based on the best available evidence, making it both safe and effective.

This trial aims to compare care that follows these guidelines with usual physical therapy care. Both types of physical therapy typically carry a low risk of side effects, so participants can feel confident about the safety of these treatments.12345

Why are researchers excited about this trial?

Researchers are excited about the Clinical Practice Guideline-adherent Care for knee pain because it offers a more personalized approach to treatment. Unlike the usual care, which relies on routine physical therapy evaluations, this method uses a specific decision tree to tailor treatments based on individual impairments. This could lead to more effective and efficient management of knee pain, addressing the unique needs of each patient rather than applying a one-size-fits-all therapy.

What evidence suggests that this Clinical Practice Guideline-adherent care is effective for patellofemoral pain?

This trial will compare Clinical Practice Guideline-adherent Care with Usual Care for knee pain. Research has shown that following specific treatment guidelines for knee pain, known as patellofemoral pain (PFP), can improve knee function and reduce pain. Studies have found that this approach can also boost confidence in performing activities related to military duties. Those who receive guideline-based care may use fewer healthcare services and require less pain medication over time. Conversely, many who receive standard care do not experience improvement in their condition after three months. Overall, evidence suggests that guideline-based care could be a more effective way to manage PFP.12346

Who Is on the Research Team?

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Sara R Gorczynski, PT, DPT

Principal Investigator

United States Naval Medical Center, San Diego

Are You a Good Fit for This Trial?

This trial is for active-duty military members with knee pain known as Patellofemoral Pain Syndrome. Participants must have specific symptoms like pain during activities that put weight on a bent knee and be available for treatment sessions within 6 weeks of joining the study.

Inclusion Criteria

I am currently serving in the military.
I have knee pain that worsens with activities like sitting, squatting, or climbing stairs.
I can start treatment within 6 weeks of joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Assessment

Participants are randomized to receive either CPG-adherent care or usual care and complete baseline assessments

1 week
1 visit (in-person)

Treatment

Participants receive physical therapy according to their group assignment (CPG-adherent care or usual care)

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months
Remote assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Clinical Practice Guideline-adherent Care
  • Usual Care

Trial Overview

The study compares two types of physical therapy: one strictly follows Clinical Practice Guidelines (CPG) for treating knee pain, while the other uses usual care methods. The goal is to see if CPG-adherent care improves knee function, reduces pain, and lowers healthcare costs over time.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Clinical Practice Guideline-adherent CareExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials
110
Recruited
24,200+

Sara Gorczynski

Lead Sponsor

Chapman University

Collaborator

Trials
10
Recruited
920+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Naval Hospital Camp Pendleton

Collaborator

Trials
5
Recruited
1,200+

Brooke Army Medical Center

Collaborator

Trials
134
Recruited
28,100+

Womack Army Medical Center

Collaborator

Trials
22
Recruited
17,100+

The Geneva Foundation

Collaborator

Trials
39
Recruited
13,700+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials
103
Recruited
94,300+

Naval Hospital Camp Pendleton

Collaborator

Trials
6
Recruited
1,300+

Citations

Protocol for a Multisite, Parallel-Arm Randomized Clinical ...

Objective: The Evaluating the Effectiveness of Clinical practice guideline Adherence for Patellofemoral Pain (knEE-CAPP) trial assesses whether ...

Evaluating the Effectiveness of Clinical Practice Guideline ...

We hypothesize CPG-adherent care will produce greater improvements in knee function, pain, and perceived confidence with performing duty-related ...

Evaluating the Effectiveness of Clinical Practice Guideline ...

Can a CPG-adherent care approach to PFP management improve short- and long-term knee function, pain, and confidence with completing duty-related ...

Patellofemoral Pain

In the individuals who received medical advice from a physician, 68% reported no improvement after 3 months, and 54% reported no improvement ...

Evaluating the Effectiveness of Clinical Practice Guideline ...

Participants may experience improved knee function, reduced pain, increased confidence in performing duty-related activities, and reduced healthcare resource ...

Differences in content of care and outcomes between a ...

T1 - Differences in content of care and outcomes between a clinical practice guideline adherent program and usual care for patellofemoral pain.