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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured every 4 weeks over 3-10 months

Awards & highlights

MOVE-OK Trial 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.Check my eligibility

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.See study design

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.

MOVE-OK Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have long-term knee arthritis.

Select...

I can walk 1/2 mile every day.

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

MOVE-OK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured every 4 weeks over 3-10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured every 4 weeks over 3-10 months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

Percent change from baseline in weekly average steps per day

Secondary outcome measures

Change in PROMIS Fatigue

Change in PROMIS pain intensity score

MOVE-OK 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,044 Total Patients Enrolled

21 Trials studying Osteoarthritis

3,301 Patients Enrolled for Osteoarthritis

Joshua F. Baker, MD MSCEPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

1 Previous Clinical Trials

34 Total Patients Enrolled

1 Trials studying Osteoarthritis

34 Patients Enrolled for Osteoarthritis

Media Library

Social Incentives and Gamification to Promote Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05035810 — Phase 3

Osteoarthritis Research Study Groups: Social Incentives and Gamification, Corticosteroid AB, No Incentive, Corticosteroid AB, Social Incentives and Gamification, Corticosteroid BA, No Incentive, Corticosteroid BA

Osteoarthritis Clinical Trial 2023: Social Incentives and Gamification to Promote Exercise Highlights & Side Effects. Trial Name: NCT05035810 — Phase 3

Social Incentives and Gamification to Promote Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05035810 — Phase 3

Osteoarthritis Patient Testimony for trial: Trial Name: NCT05035810 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study being conducted in multiple hospitals within the city limits?

"This study is being conducted out of the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, as well as the VA Puget Sound Health Care System Seattle Division in Seattle, and the Washington DC VA Medical Center in Washington. Additionally, there are 4 other locations across the states."

Answered by AI

Does this research involve any participants that are elderly?

"This trial is only seeking applicants that are aged between 40 and 80. There are 38 other trials underway for patients who are under 18 and 684 for patients over the age of 65."

Answered by AI

Who would be a good candidate for this medical study?

"250 individuals that suffer from osteoarthritis in their knees, aged 40 to 80, are being recruited for this study. Eligibility requirements for applicants include the following: being a veteran receiving care in VA Rheumatology or Orthopedic clinics, having had past joint injections, being willing to increase their physical activity, and being able to walk 1/2 mile each day."

Answered by AI

Is there a difference in safety for patients when Corticosteroid Injection is administered in A-B order opposed to another order?

"Corticosteroid Injection given in A-B order is considered safe. Our team rates it a 3 due to Phase 3 data supporting efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Is this experiment looking for more participants?

"The trial, which is currently looking for participants, was first posted on March 14th, 2022 and was most recently updated on March 30th, 2022."

Answered by AI

How many people have been accepted into this program so far?

"That is correct. The clinical trial is recruiting patients at the moment. The first posting was on March 14th, 2022 and the last update was on March 30th, 2022. They are trying to enroll 250 individuals from 4 different study locations."

Answered by AI

Who else is applying?

What state do they live in?

Pennsylvania

District of Columbia

Other

Maryland

How old are they?

65+

18 - 65

What site did they apply to?

Other

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

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

Washington DC VA Medical Center, Washington, DC

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Pain in the knees. Help myself and others. I am a fitness freak, but I still have problems with arthritis wrist, arthritis hip, and arthritis shoulder. I still excercise a lot from taking CBD . CBD helps me feel less pain while I use weight lifting.

PatientReceived 1 prior treatment

I have tried Cortizone injections but they don't last very long for my right knee; I have just received 3 jell shots but would hope for a more permanent solution. If it don't work for me, hopefully the data may help others.

PatientReceived no prior treatments