A Pragmatic Trial To Determine the Benefit of Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 of 32-40 patients 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. The investigative team includes early career investigators with experience conducting
      similar trials using this infrastructure. Results will provide preliminary data to power a
      large, feasible, and low-cost pragmatic multi-site trial that would lead to practical
      implementation. The specific aims of the study are:

      Aim 1: To determine the feasibility of recruitment and retention of Veterans with
      osteoarthritis of the knee (KOA) in a practical trial using an innovative online trial
      platform incorporating mobile activity monitors. The investigators expect to recruit and
      retain 32 Veterans within 1 year.
    

Intervention name(s): Social Incentives and Gamification to Promote Exercise; Corticosteroid Injection given in A-B order; No Social Incentive applied; Corticosteroid Injection given in B-A order
Intervention type(s): Behavioral; Procedure; Behavioral; Procedure
Intervention description(s): The intervention will provide social incentives and gamification to promote physical activity.; 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.; No social incentive will be applied; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants are randomized with a software application to receive social incentives to promote physical activity. They will also be randomized to receive corticosteroid injections in a crossover design.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: corticosteroid injection; physical activity; pain; disability; behavioral incentives