A Pragmatic Trial To Determine the Benefit of Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee

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.

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

- Unable or unwilling to identify a social sponsor

- Comorbid condition that precludes safe exercise