Clinical trial NCT03747393: Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)
Official title: Exploring the Value of the Veterans Affairs (VA) and Department of Defense (DoD) Clinical Practice Guidelines for Non-Surgical Management of Knee Osteoarthritis in the Military Health System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
physical therapy
clinical practice guidelines
military service members
self-management
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: University of Utah
First posted: 2018-11-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness parallel-group randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: This study will compare two different treatment approaches for the management of knee osteoarthritis (OA). All subjects will receive a standardized approach consistent with the core set of recommendation from the Department of Defense (DoD) and Veterans Administration (VA) Clinical Practice Guidelines for Non-Surgical Management of Knee Osteoarthritis. Follow-up will occur over a 1 year period.

Detailed description: There are gaps between actual clinical practice and published guidelines for management of knee OA. The VA/DoD Clinical Practice Guidelines leaves open the question of the effectiveness and cost-effectiveness of early referral to PT alongside the core set of management strategies for patients with knee OA. Prior studies have failed to include robust cost-effectiveness analyses to understand the policy implications of a recommendation to routinely refer patients with knee OA to PT in addition to implementing the core set of recommended management strategies. A comparative effectiveness parallel-group randomized controlled clinical trial examining these questions will be extremely informative for future updates of the VA/DoD Practice Guideline.

The core components of the clinical practice guidelines include education on nutrition and the role of obesity in OA, as well as the role of physical activity and exercise. The physical therapy component will be based on best current evidence, and consist of manual therapy, education for self-management, and exercise.

Eligibility criteria: Inclusion Criteria:

* TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of knee pain.
* Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys.
* Able to attend treatment sessions for a 4-week period.
* Age 18-60 years old
* The subject had an initial care visit in the last 90 days with a chief complaint of knee pain, or is scheduled to have one within the week.
* Satisfies American College of Rheumatology (ACR) clinical criteria for diagnosis of knee OA for at least one knee.

Exclusion Criteria:

* In the last year, the subject has received any invasive interventions including injections (corticosteroid, hyaluronic acid, etc.) or surgery for their knee
* History of Total Knee Arthroplasty (TKA)
* Has previously received formal PT for the same knee (\> 2 visits) in the last year
* Has consulted a surgeon for knee pain for either knee in the past year
* History of severe neurologic (e.g., stroke, Parkinson's disease, etc.) or other condition that prevents walking independently for at least 5 minutes or engaging in a physical activity/exercise program.
* Anyone leaving military service for other than regular retirement, pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.
* Systemic disease that could otherwise be responsible for the subjects knee pain (e.g. rheumatoid arthritis, gout, or psoriatic arthritis), non-musculoskeletal conditions causing knee pain, personal history of neoplasm, current or recent knee joint infection, recent fall/trauma to knee, acute fracture of knee, lower extremity amputation, or other more likely primary musculoskeletal knee disorders (e.g. patellar tendinopathy, bursitis, runner's knee, etc.)
* Currently has a referral to orthopedics or physical therapy for a knee disorder

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function
timeFrame: 2 years
Secondary outcomes:
measure: Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 2 years
measure: Patient Acceptable Symptom Scale (PASS)
timeFrame: 2 years
measure: EuroQoL (EQ-5D)
timeFrame: 2 years
Other outcomes:
measure: Healthcare Utilization from Electronic Medical Records (EMR)
timeFrame: 2 years
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: 2 years
measure: Marcus 5 Item Exercise Self Efficacy Scale (MESE)
timeFrame: 2 years
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Brooke Army Medical Center
name: Daniel I Rhon, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
citation: Uthman OA, van der Windt DA, Jordan JL, Dziedzic KS, Healey EL, Peat GM, Foster NE. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. BMJ. 2013 Sep 20;347:f5555. doi: 10.1136/bmj.f5555.
citation: Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8.
citation: Dhawan A, Mather RC 3rd, Karas V, Ellman MB, Young BB, Bach BR Jr, Cole BJ. An epidemiologic analysis of clinical practice guidelines for non-arthroplasty treatment of osteoarthritis of the knee. Arthroscopy. 2014 Jan;30(1):65-71. doi: 10.1016/j.arthro.2013.09.002. Epub 2013 Nov 28.
citation: Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.