Knee OsteoarthritisNCT03747393
Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)
A study testing DoD/VA CPG Core Set + PT and DoD/VA CPG Core Set in people with Knee Osteoarthritis, run by Brooke Army Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- DoD/VA CPG Core Set + PT and DoD/VA CPG Core Set
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2019to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brooke Army Medical Center
San Antonio, Texas, 78219
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, 78236
Madigan Army Medical Center
Tacoma, Washington, 98391
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- DoD/VA CPG Core Set + PT, DoD/VA CPG Core Set
- Keywords
- knee osteoarthritis, physical therapy, clinical practice guidelines, military service members, self-management
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoD/VA CPG Core Set + PTBehavioural
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 SetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: DoD/VA CPG Core Set + PT; Behavioral: DoD/VA CPG Core Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Osteoarthritis score, which consists of 24 questions, and 3 different subscales: pain (Q1-5), stiffness (Q6-7) and physical function (Q8-24)
Measured: 2 years
Patient Acceptable Symptom Scale (PASS)
The PASS is a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms. This tool has been validated in patients with OA. The PASS asks the patient; "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Response options are "yes" or "no".
Measured: 2 years
EuroQoL (EQ-5D)
The EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222). The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Jun 2019
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness parallel-group randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel I Rhon, DSc, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747393
- Sponsor's protocol ID
- C2018.117d
- Other IDs
- W81XWH-18-1-0788
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2018
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is proprietary to the US Defense Health Agency (DHA) and can be requested through a Data Sharing Agreement Application that must then be approved by the Data Privacy Board at DHA.
Publications
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.
PubMed 15208174Uthman 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.
PubMed 24055922Abbott 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.
PubMed 23313532Dhawan 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.
PubMed 24290788Deyle 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.
PubMed 16305269
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03747393
- Acronym / sponsor ID
- C2018.117d
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, physical therapy, clinical practice guidelines, military service members, self-management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- University of Utah
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative effectiveness parallel-group randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| DoD/VA CPG Core Set | Active comparator | Behavioral: DoD/VA CPG Core SetThe standard core set of interventions recommended by the DoD/VA clinical practice guidelines for non-surgical management of knee OA. |
| DoD/VA CPG Core Set + PT | Experimental | Behavioral: DoD/VA CPG Core Set + PT, Behavioral: DoD/VA CPG Core SetIn 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoD/VA CPG Core Set + PTParticipants 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. | Behavioural | DoD/VA CPG Core Set + PT |
| DoD/VA CPG Core SetThe 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. | Behavioural | DoD/VA CPG Core Set, DoD/VA CPG Core Set + PT |
Primary outcome
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function
Time frame: 2 years
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.
3 secondary outcomes
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 years
Patient Acceptable Symptom Scale (PASS)
Time frame: 2 years
EuroQoL (EQ-5D)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 15208174Tubach 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.
- Background: PubMed 24055922Uthman 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.
- Background: PubMed 23313532Abbott 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.
- Background: PubMed 24290788Dhawan 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.
- Background: PubMed 16305269Deyle 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.
- Individual participant dataSharing planned: Undecided. Data is proprietary to the US Defense Health Agency (DHA) and can be requested through a Data Sharing Agreement Application that must then be approved by the Data Privacy Board at DHA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Rhon, DSc principal investigator
Brooke Army Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DoD/VA CPG Core Set + PT and DoD/VA CPG Core Set in people with Knee Osteoarthritis, run by Brooke Army Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.