Non-Surgical Management for Knee Osteoarthritis

Recruiting at 2 trial locations

Overseen By Brian Hatler, DPT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Invasive interventions, Total knee arthroplasty, Severe neurologic conditions, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two non-surgical methods to manage knee osteoarthritis. Participants will follow a standard set of treatments recommended by the Department of Defense and Veterans Administration (DoD/VA CPG Core Set), with some also attending physical therapy sessions. The researchers aim to determine if adding physical therapy improves knee pain management over a year. Individuals with recent knee pain who meet the basic criteria for knee osteoarthritis may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance knee osteoarthritis management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the DoD/VA Clinical Practice Guidelines for managing knee osteoarthritis emphasize non-surgical treatments. These guidelines emerged from a thorough review of data on treatment responses.

The guidelines are safe and effective for most individuals. They recommend physical therapy, which includes exercises and techniques to enhance movement and reduce pain. Many patients have experienced positive outcomes with these methods, with very few encountering serious side effects.

Incorporating physical therapy (PT) into the main guidelines can enhance benefits. PT is generally safe and often reduces pain and improves movement. Most individuals tolerate it well, experiencing only minor side effects like soreness or tiredness after sessions.

The treatments in this study have strong safety evidence. They are based on guidelines widely used by doctors and therapists in military and veterans’ health systems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the non-surgical management options for knee osteoarthritis being tested because they offer a comprehensive approach that goes beyond standard care. The DoD/VA CPG Core Set represents a set of best practice guidelines tailored for managing knee OA without surgery and includes interventions like pain management strategies and lifestyle modifications. The addition of physical therapy (PT) to this core set is particularly promising because it incorporates targeted exercise, manual therapy, and patient education, potentially enhancing outcomes by addressing mobility and strengthening the knee. This combined approach could provide more holistic benefits, improving function and quality of life for those with knee osteoarthritis.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

This trial will compare two non-surgical management approaches for knee osteoarthritis. One group will follow the Department of Defense and Veterans Affairs guidelines, which emphasize non-surgical methods such as patient education and self-care encouragement. These methods are based on a careful review of clinical and health studies. Another group will receive the same guidelines plus additional physical therapy, including exercises and hands-on treatment. Studies have found that adding physical therapy can further improve results, effectively reducing pain and enhancing movement in people with knee osteoarthritis. Combining these approaches is believed to make managing this condition without surgery more effective. ^{1 3 5 6 7}

Who Is on the Research Team?

Daniel Rhon, PhD

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

This trial is for TRICARE beneficiaries aged 18-60 with knee pain and a diagnosis of knee osteoarthritis, who can attend treatment sessions over a month. It's not for those who've had recent invasive knee treatments, consulted a surgeon in the past year, or have conditions like severe neurologic disorders or systemic diseases that could explain their knee pain.

Inclusion Criteria

I can attend treatment sessions for 4 weeks.

I have seen or will see a doctor for knee pain within 3 months.

Satisfies American College of Rheumatology (ACR) clinical criteria for diagnosis of knee OA for at least one knee

Exclusion Criteria

My knee pain is not due to conditions like arthritis, gout, or injury.

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

I have had knee surgery or injections in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standardized approach consistent with the core set of recommendations from the DoD and VA Clinical Practice Guidelines for Non-Surgical Management of Knee Osteoarthritis, with or without additional physical therapy

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares two non-surgical treatments for managing knee osteoarthritis over one year. Everyone gets standard care based on DoD/VA guidelines; some also get additional physical therapy (PT). The goal is to see if adding PT improves outcomes.

How Is the Trial Designed?

Group I: DoD/VA CPG Core Set + PT Experimental Treatment 2 Interventions

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).

Group II: DoD/VA CPG Core Set Active Control 1 Intervention

The 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 is already approved in United States for the following indications:

Approved in United States as DoD/VA CPG Core Set for:

• Non-Surgical Management of Knee Osteoarthritis

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A study of 86,081 patients undergoing total knee arthroplasty (TKA) found that 65.8% received at least one treatment for knee osteoarthritis (OA) in the year prior, with non-recommended treatments accounting for a significant portion of costs.

Hyaluronic acid (HA) injections, which are not supported by clinical practice guidelines, represented 29.3% of the total non-inpatient costs for knee OA, suggesting that adhering to recommended treatments could potentially reduce costs by 45%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty? Bedard, NA., Dowdle, SB., Anthony, CA., et al.[2022]

Clinical practice guidelines (CPGs) can enhance the quality of orthopedic care by standardizing treatment approaches, but their effectiveness is limited by the often weak evidence base in orthopedic research.

Surgeons have concerns about legal liability when using CPGs, but proper development and implementation processes can mitigate these risks and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guidelines: their use, misuse, and future directions. Sanders, JO., Bozic, KJ., Glassman, SD., et al.[2022]

Out of 20 clinical practice guidelines (CPGs) for osteoarthritis management, 11 were rated as high quality, emphasizing the importance of patient-centered care that includes exercise, education, and weight loss when appropriate.

For patients with disabling osteoarthritis that hasn't improved with nonsurgical treatments, nonsteroidal anti-inflammatory drugs and surgical options are recommended, along with the use of hand orthoses for those with hand osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core Recommendations for Osteoarthritis Care: A Systematic Review of Clinical Practice Guidelines. Conley, B., Bunzli, S., Bullen, J., et al.[2023]

A review of 34 clinical practice guidelines (CPGs) for osteoarthritis (OA) of the hip and knee found that while most recommendations were consistent, the quality of these guidelines varied significantly, with few receiving a 'strongly recommended' rating.

The study suggests that instead of creating new guidelines, efforts should focus on adapting existing ones to local contexts and implementing effective practices, as well as conducting research to address gaps in evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and consistency of clinical practice guidelines for diagnosis and management of osteoarthritis of the hip and knee: a descriptive overview of published guidelines. Misso, ML., Pitt, VJ., Jones, KM., et al.[2020]

A survey of 822 Italian physiotherapists revealed that while there is a good understanding of osteoarthritis clinical practice guidelines (CPGs), with consensus on 13 out of 24 statements, adherence to these guidelines is lacking.

Only 25% of physiotherapists were classified as 'Delivering' the recommended interventions for osteoarthritis, indicating a significant evidence-to-practice gap that could lead to suboptimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Italian physiotherapists' knowledge of and adherence to osteoarthritis clinical practice guidelines: a cross-sectional study. Battista, S., Salvioli, S., Millotti, S., et al.[2022]

A systematic review of 9 clinical practice guidelines (CPGs) for physical therapy management of nontraumatic shoulder pain found that only 3 were of high quality, all of which were over 5 years old, indicating a lack of contemporary high-quality guidelines.

The highest-rated quality domains were 'scope and purpose' and 'clarity of presentation,' while the lowest-rated domains were 'applicability' and 'editorial independence,' suggesting that many guidelines may not be practical or unbiased for current clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy Management of Nontraumatic Shoulder Problems Lacks High-Quality Clinical Practice Guidelines: A Systematic Review With Quality Assessment Using the AGREE II Checklist. Barrett, E., Larkin, L., Caulfield, S., et al.[2021]

In a review of 1096 visits for knee osteoarthritis, adherence to the American Academy of Orthopaedic Surgeons' guidelines was only 65% for new patients and decreased to 40% for returning patients, indicating a need for better compliance with established treatment protocols.

The most common interventions were intra-articular injections and physical therapy, but the use of hyaluronic acid injections was notably expensive and contradicted by strong evidence against its effectiveness, highlighting the importance of aligning treatment choices with clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the American Academy of Orthopaedic Surgeons Clinical Practice Guidelines for Nonoperative Management of Knee Osteoarthritis. Meiyappan, KP., Cote, MP., Bozic, KJ., et al.[2022]

The new clinical practice guideline for managing hip and knee osteoarthritis, approved by the VA and DoD, emphasizes evidence-based recommendations across six key areas, including diagnosis, self-management, and physical therapy.

The guideline was developed through a systematic review of literature and stakeholder input, resulting in 19 recommendations aimed at improving non-surgical treatment options for osteoarthritis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synopsis of the 2020 US Department of Veterans Affairs/US Department of Defense Clinical Practice Guideline: The Non-Surgical Management of Hip and Knee Osteoarthritis. Krishnamurthy, A., Lang, AE., Pangarkar, S., et al.[2021]

A review of 10 clinical practice guidelines (CPGs) for knee osteoarthritis published between 2014 and 2019 found that over half were of high quality, with scores ranging from 42% to 100%.

All CPGs recommended exercise as a key intervention, while weight management and education were also frequently suggested, highlighting their importance in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and content analysis of clinical practice guidelines which include nonpharmacological interventions for knee osteoarthritis. Tittlemier, BJ., Wittmeier, KD., Webber, SC.[2022]

A review of 17 clinical practice guidelines (CPGs) for osteoarthritis (OA) revealed that while most guidelines provided recommendations for non-pharmacological management, they often lacked thoroughness in key quality areas, with an average AGREE II score of 4.8 out of 7.

Commonly recommended non-pharmacological interventions for OA included therapeutic exercises, patient education, and various physical therapies, but many CPGs inadequately addressed these interventions, highlighting the need for improved guideline development and implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic critical appraisal for non-pharmacological management of osteoarthritis using the appraisal of guidelines research and evaluation II instrument. Brosseau, L., Rahman, P., Toupin-April, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03747393

Non-Surgical Management of Knee Osteoarthritis in the ... This study will compare two different treatment approaches for the management of knee osteoarthritis (OA). All subjects will receive a standardized approach ...

2. healthquality.va.gov healthquality.va.gov/guidelines/CD/OA/VADoDOACPG.pdf

VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE NON ... This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary ...

3. clinicaltrial.be clinicaltrial.be/en/details/66371?per_page=100&only_recruiting=1&only_eligible=0&only_active=0

Non-Surgical Management of Knee Osteoarthritis in the Mil... The published clinical practice guideline recommends early use of a core set of management strategies to include patient education about their ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492051/

Implementation of Group Physical Therapy for Knee ... Group-based physical therapy (PT) for knee osteoarthritis is an effective, efficient strategy for delivering care, but little is known about ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-5-2019-a6cc0

Non-Surgical Management for Knee Osteoarthritis This study will compare two different treatment approaches for the management of knee osteoarthritis (OA). All subjects will receive a standardized approach ...

6. healthquality.va.gov healthquality.va.gov/HEALTHQUALITY/guidelines/CD/OA/index.asp

The Non-Surgical Management of Hip & Knee ... The OA CPG recommends a framework that includes a structured evaluation and diagnosis of Veterans and Service Members who may be suffering from hip and knee ...

7. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(21)00241-X/fulltext

Synopsis of the 2020 US Department of Veterans Affairs ... Clinical practice guidelines were developed jointly by the VA and DoD to address the nonoperative treatment of OA of the hip and knee, focusing on imaging for ...