A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee Marching On for Veterans With Osteoarthritis of the Knee

Study Purpose

Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans. Management of KOA is challenging as there are few effective treatments other than joint replacement. Importantly, low levels of physical activity in patients with knee problems might worsen pain and disability. This study aims to determine the feasibility of using methods to change behavior that use social incentives and promote physical activity through playing games and interacting with a web-based platform. The study will also evaluate an important and widely used treatment, namely corticosteroid injections. Participants will be randomized into one of 4 arms and will receive a different combination of social incentives and injections. The study will evaluate which approach is most effective at promoting physical activity and reducing pain and disability.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Veterans in VA Rheumatology or Orthopedic clinics.
  • - Chronic knee osteoarthritis.
  • - Indication for joint injection.
  • - Previous joint injections for palliation.
  • - Patient expresses interest in increasing their physical activity.
  • - Patient is able to walk 1/2 mile per day.

Exclusion Criteria:

  • - Intra-articular hardware or other contraindication to joint injection.
  • - Lack of smart phone.
  • - Acute exacerbation of osteoarthritis or knee pain.
- Comorbid condition that precludes safe exercise

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05035810
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joshua F. Baker, MD MSCE
Principal Investigator Affiliation Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis of the Knee
Additional Details

Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among Veterans and accounts for high morbidity and high costs for the VA. Management of KOA is challenging as there are few consistently effective treatments other than joint replacement. Importantly, chronic reductions in physical activity in patients with KOA may worsen pain, physical function, and exacerbate the metabolic consequences of obesity. Moreover, the greater mortality observed in symptomatic knee OA populations is likely mediated through its effect on physical activity. The current proposal aims to derive preliminary data to support a large pragmatic trial testing the impact of interventions geared towards improving physical activity and function in KOA patients. Promoting physical activity has been shown to be helpful in reducing pain and improving function in KOA and other groups. However, promoting behavioral change in the arthritis population is a significant challenge. The group has shown that social incentives [and gamification] derived from concepts from the field of behavioral economics to promote behavioral change and increase physical activity can be both practical and effective in other settings. The investigators' group is studying incentives in patients with inflammatory arthritis with the goal of addressing fatigue, pain, and deficits in physical function. The incentivization of physical activity using this approach represents a novel intervention for the managing symptoms of KOA and to improving overall health. Analgesic therapies can help KOA patients participate in exercise therapy. However, whether corticosteroid injections, a commonly used medical therapy for KOA pain, has a positive impact of physical activity is unknown and is an additional important question addressed by the current proposal. Despite widespread use, definitive data demonstrating a consistent benefit of corticosteroids are lacking. A large randomized trial recently tested the effects of repeated corticosteroids injections every 3 months for a period of 2 years on patient reported pain as well as progression of disease measured by magnetic resonance imaging (MRI). This study demonstrated no improvement in pain compared to saline injections. In addition, a small but statistically significant decline in cartilage thickness on MRI was observed, raising a concern for side effects. These recent data might suggest that corticosteroid injections result in more harm than good, and may discourage providers from performing this intervention. However, there are critical weaknesses to this study. Pain and function were only assessed at 3-month intervals, while previous trials have suggested that peak benefit is expected at 4-8 weeks. Moreover, the clinical and biologic significance decrease in cartilage thickness is unclear. The investigators propose to fill these important knowledge gaps with an innovative and efficient pragmatic clinical trial with a factorial and crossover design. A large and definitive practical trial would lead to better understanding of the clinical effectiveness of these interventions, the meaningfulness of their combined impact, and the subgroups that are most likely to derive benefit. This clinical trial will leverage unique resources available through the Penn Center for Innovation to better capture important patient-reported outcomes in real-time through a web-based platform. The study will also test the feasibility of a crossover and factorial design to improve efficiency and reduce confounding. Each patient will receive each intervention (saline, corticosteroids) in random order over 1 year. A factorial design will be employed and will randomize participants to receive social incentives with gamification to promote increases in their physical activity. To accomplish these aims, the investigators will utilize innovative mobile applications for smart phones and wearable activity trackers through the Way-to-Health platform and assess, in real time, the impact of the intervention on patient-reported function and pain as well as physical activity. The technology will allow for the recording of outcomes as they occur, between clinic visits, thereby avoiding information bias due to poor recall. It will also provide real-time assessment of symptoms, providing granular assessments of response over time. Aim 1: To determine whether an incentive based on behaviorally-enhanced gamification can improve physical activity among patients with KOA and reduce self-reported pain and disability. The intervention will result in sustained improvements in average daily step counts over 10 months. Aim 2: To determine if corticosteroid injections can reduce pain and disability in patients with KOA when compared to lidocaine only. Participants will report improvements in self-reported pain and disability, and improvements in quality of life.

Arms & Interventions

Arms

Experimental: Social Incentives and Gamification, Corticosteroid AB

Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals. The participants will receive injections in A-B order (corticosteroids, then lidocaine only)

Active Comparator: No Incentive, Corticosteroid AB

Participants will only receive reminders to sync their activity monitor. The participants will receive injections in A-B order (corticosteroids, then lidocaine only)

Experimental: Social Incentives and Gamification, Corticosteroid BA

Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals. The participants will receive injections in B-A order (lidocaine only, then corticosteroids)

Active Comparator: No Incentive, Corticosteroid BA

Participants will only receive reminders to sync their activity monitor. The participants will receive injections in B-A order (lidocaine only, then corticosteroids)

Interventions

Behavioral: - Social Incentives and Gamification to Promote Exercise

The intervention will provide social incentives and gamification to promote physical activity.

Drug: - Corticosteroid Injection given in A-B order

The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.

Behavioral: - No Social Incentive applied

No social incentive will be applied

Drug: - Procedure: Corticosteroid Injection given in B-A order

The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington, District of Columbia

Status

Recruiting

Address

Washington DC VA Medical Center, Washington, DC

Washington, District of Columbia, 20422

Site Contact

Mercedes Quinones, MD

[email protected]

202-745-8000

Omaha, Nebraska

Status

Recruiting

Address

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1873

Site Contact

Bryant England, MD

[email protected]

402-888-6728

Philadelphia, Pennsylvania

Status

Recruiting

Address

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104

Site Contact

Joshua F Baker, MD MSCE

[email protected]

215-823-5800

Seattle, Washington

Status

Recruiting

Address

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108

Site Contact

Katherine D Wyshan, MD

[email protected]

206-764-2251