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Non-Surgical Management for Knee Osteoarthritis

N/A

Recruiting

Led By Daniel I Rhon, DSc

Research Sponsored by Brooke Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-60 years old

Be between 18 and 65 years old

Must not have

Has previously received formal PT for the same knee (> 2 visits) in the last year

Currently has a referral to orthopedics or physical therapy for a knee disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different ways of treating knee osteoarthritis. All subjects will receive a standardized approach recommended by the Department of Defense and Veterans Administration. Follow-up will occur over a 1 year period.

Who is the study for?

This trial is for TRICARE beneficiaries aged 18-60 with knee pain and a diagnosis of knee osteoarthritis, who can attend treatment sessions over a month. It's not for those who've had recent invasive knee treatments, consulted a surgeon in the past year, or have conditions like severe neurologic disorders or systemic diseases that could explain their knee pain.

What is being tested?

The study compares two non-surgical treatments for managing knee osteoarthritis over one year. Everyone gets standard care based on DoD/VA guidelines; some also get additional physical therapy (PT). The goal is to see if adding PT improves outcomes.

What are the potential side effects?

Since this trial involves non-surgical methods like guideline-based care and physical therapy, side effects may include muscle soreness or discomfort from exercises. No drug-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had physical therapy for my knee more than twice in the past year.

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I have been referred to a specialist or physical therapy for a knee problem.

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I have seen a surgeon for knee pain in the last year.

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I cannot walk by myself for 5 minutes due to a severe neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function

Secondary study objectives

EuroQoL (EQ-5D)

Patient Acceptable Symptom Scale (PASS)

Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

Other study objectives

Credibility Expectancy Questionnaire (CEQ)

Healthcare Utilization from Electronic Medical Records (EMR)

Marcus 5 Item Exercise Self Efficacy Scale (MESE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DoD/VA CPG Core Set + PTExperimental Treatment2 Interventions

In addition to DoD/VA clinical practice guidelines, patients will be referred to physical therapy (PT). Physical therapy will consist of evidence-based interventions that can be provided by a PT (exercise, manual therapy, education).

Group II: DoD/VA CPG Core SetActive Control1 Intervention

The standard core set of interventions recommended by the DoD/VA clinical practice guidelines for non-surgical management of knee OA.

0 / 5Eligibility criteria met