Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)

NCT03747393 | Active Not Recruiting

• 2 other identifiers: C2018.117dW81XWH-18-1-0788
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; physical therapy; clinical practice guidelines; military service members; self-management

Outcome Measures

Primary Outcomes (1)

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

  The PROMIS is managed and endorsed by the NIH, and will be based on the Computer Adaptive Test, which does not have a set number of questions but instead "adapts" the test and number of questions based on prior answers it receives.

  2 years

Secondary Outcomes (3)

• Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

  2 years

• Patient Acceptable Symptom Scale (PASS)

  2 years

• EuroQoL (EQ-5D)

  2 years

Other Outcomes (3)

• Healthcare Utilization from Electronic Medical Records (EMR)

  2 years

• Credibility Expectancy Questionnaire (CEQ)

  2 years

• Marcus 5 Item Exercise Self Efficacy Scale (MESE)

  2 years

Study Arms (2)

DoD/VA CPG Core Set

ACTIVE COMPARATOR

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

Behavioral: DoD/VA CPG Core Set

DoD/VA CPG Core Set + PT

EXPERIMENTAL

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).

Behavioral: DoD/VA CPG Core Set + PT; Behavioral: DoD/VA CPG Core Set

Interventions

DoD/VA CPG Core Set + PT BEHAVIORAL

Participants randomized to receive the core set management class and physical therapy will be scheduled for their initial physical therapy evaluation approximately 1 week from their enrollment date. The purpose of the evaluation will be to identify relevant impairments that can be addressed during the physical therapy treatments. After this initial evaluation, the goal is for the patient to receive approximately 4 weeks of physical therapy (about 8-10 sessions in the clinic 2-3 times per week). Consistent with a pragmatic study we will not use placebos to blind patients or attempt to balance provider contact.

DoD/VA CPG Core Set + PT

DoD/VA CPG Core Set BEHAVIORAL

The published clinical practice guideline recommends early use of a core set of management strategies to include patient education about their condition and the role of obesity in disease progression, activity and lifestyle modification focusing on physical activity, and a therapeutic exercise program. Implementation of the core set is recommended prior to any referral for consultation about invasive procedures such as intra-articular injections or TKA surgery. All patients with knee pain will be scheduled to receive the core set management strategy class as a part of the usual care route.

DoD/VA CPG Core Set; DoD/VA CPG Core Set + PT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: collaborator
• Brooke Army Medical Center: lead

Study Sites (3)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98391, United States

Location

Related Publications (5)

• 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.

  PMID: 15208174 BACKGROUND

• 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.

  PMID: 24055922 BACKGROUND

• 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.

  PMID: 23313532 BACKGROUND

• 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.

  PMID: 24290788 BACKGROUND

• 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.

  PMID: 16305269 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Daniel I Rhon, DSc

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Primary Care Musculoskeletal Research Center

Model Details: Comparative effectiveness parallel-group randomized controlled clinical trial

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: June 1, 2019
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (3)