Back to results

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

Primary Purpose

Knee Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DoD/VA CPG Core Set + PT

DoD/VA CPG Core Set

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, physical therapy, clinical practice guidelines, military service members, self-management

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brooke Army Medical CenterRecruiting
Wilford Hall Ambulatory Surgical CenterRecruiting
Madigan Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DoD/VA CPG Core Set

DoD/VA CPG Core Set + PT

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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".

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.

Full Information

NCT ID

NCT03747393

First Posted

November 14, 2018

Last Updated

April 18, 2023

Sponsor

Brooke Army Medical Center

Collaborators

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT03747393

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

Collaborators

University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Comparative effectiveness parallel-group randomized controlled clinical trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DoD/VA CPG Core Set

Arm Type

Active Comparator

Arm Description

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

Arm Title

DoD/VA CPG Core Set + PT

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

DoD/VA CPG Core Set + PT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

DoD/VA CPG Core Set

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

Description

The WOMAC Osteoarthritis score, which consists of 24 questions, and 3 different subscales: pain (Q1-5), stiffness (Q6-7) and physical function (Q8-24)

Time Frame

2 years

Title

Patient Acceptable Symptom Scale (PASS)

Description

Time Frame

2 years

Title

EuroQoL (EQ-5D)

Description

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Healthcare Utilization from Electronic Medical Records (EMR)

Description

Healthcare utilization will be extracted for all participants for the 2 year period following . enrollment. Drug prescriptions, medical procedures, and specialty referrals will be identified.

Time Frame

2 years

Title

Credibility Expectancy Questionnaire (CEQ)

Description

The CEQ, a 6-item self-report evaluating treatment credibility and expectations for improvement, will be assessed at baseline after treatment group assignment is revealed to provide descriptive information about participants' perceptions of their treatment assignment and optimism for improvement. The CEQ may be used as a covariate if perceptions differ meaningfully between groups as participants' initial perceptions of treatment credibility can impact outcomes.

Time Frame

2 years

Title

Marcus 5 Item Exercise Self Efficacy Scale (MESE)

Description

The MESE is a 5 item self report measure of exercise self efficacy with good validity and reliability. Higher scores reflect higher self efficacy. Participants rate their confidence in the ability to participate in regular exercise when faced with barriers and obstacles such as fatigue, vacation or poor weather.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Mayhew, DPT

Phone

206-450-0075

rachel.j.mayhew.ctr@mail.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Laugesen, DPT

Phone

210-808-2575

mary.c.laugesen.ctr@mail.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel I Rhon, DSc

Organizational Affiliation

Brooke Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Laugesen, DPT

Phone

210-808-2575

mary.c.laugesen.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Bryan Pickens, DSc

Facility Name

Wilford Hall Ambulatory Surgical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78236

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenae Day, DPT

chenae.j.day.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Benjamin Hando, DSc

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98391

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel J Mayhew, DPT

rachel.J.mayhew.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Brian Hatler, DPT

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

15208174

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.

Results Reference

background

PubMed Identifier

24055922

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.

Results Reference

background

PubMed Identifier

23313532

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.

Results Reference

background

PubMed Identifier

24290788

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.

Results Reference

background

PubMed Identifier

16305269

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.

Results Reference

background

Links:

URL

https://www.healthquality.va.gov/guidelines/CD/OA/VADoDOACPGFINAL090214.pdf

Description

VA/DoD Clinical Practice Guideline for the Non-Surgical Management of Hip and Knee Osteoarthritis

Learn more about this trial

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

We'll reach out to this number within 24 hrs