Exercise Incentives + Corticosteroid Injections for Osteoarthritis

(MOVE-OK Trial)

Recruiting at 3 trial locations

Overseen By William T Leach, MA BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must be taking: Corticosteroids

Disqualifiers: Intra-articular hardware, Lack of smartphone, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

221 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joshua Baker, MD

Principal Investigator

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

Eligibility Criteria

This trial is for Veterans with chronic knee osteoarthritis who have had joint injections before, want to increase their physical activity, and can walk at least half a mile per day. It's not for those without a smartphone, in acute pain, with conditions that make exercise unsafe, or with knee hardware that prevents injections.

Inclusion Criteria

Veterans in VA Rheumatology or Orthopedic clinics

I need an injection in my joint.

I have long-term knee arthritis.

Exclusion Criteria

I have hardware in my joint or a reason I can't have joint injections.

Comorbid condition that precludes safe exercise

Lack of smart phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive social incentives and gamification or no incentives, along with corticosteroid or lidocaine injections in a crossover design

12 months

Bi-weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Corticosteroid Injection
• Social Incentives and Gamification to Promote Exercise

Trial Overview The study tests if social incentives and gamification can boost exercise among these patients versus corticosteroid injections alone. Participants are randomly placed into one of four groups to see which combination best increases physical activity and reduces pain and disability.

Participant Groups

Group I: Social Incentives and Gamification, Corticosteroid BA Experimental Treatment 2 Interventions

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)

Group II: Social Incentives and Gamification, Corticosteroid AB Experimental Treatment 2 Interventions

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)

Group III: No Incentive, Corticosteroid AB Active Control 2 Interventions

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

Group IV: No Incentive, Corticosteroid BA Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+