Study 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.
Eligible Conditions
- Osteoarthritis of the Knee
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 2 years
2 years
Credibility Expectancy Questionnaire (CEQ)
EuroQoL (EQ-5D)
Healthcare Utilization from Electronic Medical Records (EMR)
Marcus 5 Item Exercise Self Efficacy Scale (MESE)
Patient Acceptable Symptom Scale (PASS)
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
DoD/VA CPG Core Set
1 of 2
DoD/VA CPG Core Set + PT
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: DoD/VA CPG Core Set + PT · No Placebo Group · N/A
DoD/VA CPG Core Set + PTExperimental Group · 2 Interventions: DoD/VA CPG Core Set + PT, DoD/VA CPG Core Set · Intervention Types: Behavioral, Behavioral
DoD/VA CPG Core Set
Behavioral
ActiveComparator Group · 1 Intervention: DoD/VA CPG Core Set · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Brooke Army Medical CenterLead Sponsor
110 Previous Clinical Trials
26,740 Total Patients Enrolled
3 Trials studying Osteoarthritis of the Knee
234 Patients Enrolled for Osteoarthritis of the Knee
University of UtahOTHER
1,000 Previous Clinical Trials
1,781,938 Total Patients Enrolled
2 Trials studying Osteoarthritis of the Knee
224 Patients Enrolled for Osteoarthritis of the Knee
Daniel I Rhon, DScPrincipal InvestigatorBrooke Army Medical Center
2 Previous Clinical Trials
1,472 Total Patients Enrolled
Eligibility Criteria
Age 18 - 60 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For this condition, you must be TRICARE eligible and have a primary complaint of knee pain.
You have a diagnosis of knee OA for at least one knee.
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.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Brooke Army Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Dhawan, Aman, Richard C. Mather III, Vasili Karas, Michael B. Ellman, Benjamin B. Young, Bernard R. Bach Jr., and Brian J. Cole. 2014. “An Epidemiologic Analysis of Clinical Practice Guidelines for Non-arthroplasty Treatment of Osteoarthritis of the Knee”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2013.09.002.
- Abbott, J.H., M.C. Robertson, C. Chapple, D. Pinto, A.A. Wright, S. Leon de la Barra, G.D. Baxter, J.-C. Theis, and A.J. Campbell. 2013. “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 and Cartilage. Elsevier BV. doi:10.1016/j.joca.2012.12.014.
- Tubach, F. 2005. “Evaluation of Clinically Relevant Changes in Patient Reported Outcomes in Knee and Hip Osteoarthritis: The Minimal Clinically Important Improvement”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/ard.2004.022905.
- Uthman, O. A., D. A. van der Windt, J. L. Jordan, K. S. Dziedzic, E. L. Healey, G. M. Peat, and N. E. Foster. 2013. “Exercise for Lower Limb Osteoarthritis: Systematic Review Incorporating Trial Sequential Analysis and Network Meta-analysis”. Bmj. BMJ. doi:10.1136/bmj.f5555.
- Silva, Luciana E, Valeria Valim, Ana Paula C Pessanha, Leda M Oliveira, Samira Myamoto, Anamaria Jones, and Jamil Natour. 2008. “Hydrotherapy Versus Conventional Land-based Exercise for the Management of Patients with Osteoarthritis of the Knee: A Randomized Clinical Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20060040.
- Silva, Luciana E, Valeria Valim, Ana Paula C Pessanha, Leda M Oliveira, Samira Myamoto, Anamaria Jones, and Jamil Natour. 2008. “Hydrotherapy Versus Conventional Land-based Exercise for the Management of Patients with Osteoarthritis of the Knee: A Randomized Clinical Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20060040.
- 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.
- 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.
- Dan Rhon 2019. "Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747393.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments