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Exercise Incentives + Corticosteroid Injections for Osteoarthritis (MOVE-OK Trial)

Phase 3

Recruiting

Led By Joshua F. Baker, MD MSCE

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic knee osteoarthritis

Patient is able to walk 1/2 mile per day

Must not have

Intra-articular hardware or other contraindication to joint injection

Acute exacerbation of osteoarthritis or knee pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured every 4 weeks over 3-10 months (3 for injection intervention and 10 for exercise intervention)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study whether social incentives and game-based interaction can help manage knee osteoarthritis pain and disability, as well as whether corticosteroid injections are an effective treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Corticosteroid injections may cause side effects like increased pain at the injection site, infection risk, skin discoloration, allergic reactions or weakening of nearby bones. The behaviorally enhanced exercises should be safe but might lead to overexertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have long-term knee arthritis.

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I can walk 1/2 mile every day.

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I have had injections in my joints for pain relief before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently experiencing a sudden worsening of my knee pain or osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured every 4 weeks over 3-10 months (3 for injection intervention and 10 for exercise intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured every 4 weeks over 3-10 months (3 for injection intervention and 10 for exercise intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 4 weeks over 3-10 months (3 for injection intervention and 10 for exercise intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

Percent change from baseline in weekly average steps per day

Secondary study objectives

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS)

Change in PROMIS Fatigue

Change in PROMIS pain intensity score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Social Incentives and Gamification, Corticosteroid BAExperimental Treatment2 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 ABExperimental Treatment2 Interventions

Group III: No Incentive, Corticosteroid ABActive Control2 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 BAActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Social Incentives and Gamification to Promote Exercise

2019

N/A

~40

Corticosteroid Injection given in A-B order

2019

N/A

~40