Exercise Incentives + Corticosteroid Injections for Osteoarthritis

(MOVE-OK Trial)

Not currently recruiting at 4 trial locations
JF
WT
Overseen ByWilliam T Leach, MA BS
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: VA Office of Research and Development
Must be taking: Corticosteroids
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans with knee osteoarthritis (painful and stiff joints) by testing methods to encourage exercise and using corticosteroid injections (a type of anti-inflammatory medication) to reduce pain. Researchers will divide participants into four groups to determine which combinations of social support and injections best boost activity and ease discomfort. This trial suits veterans with ongoing knee issues, previous joint injections, and a desire to become more active. Participants should be able to walk about half a mile daily.

As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that social rewards and game-like features can encourage people to be more active. One study found that these methods increased moderate-to-vigorous physical activity. Another study found that exercise programs with game elements boosted activity levels without affecting quality of life.

For corticosteroid injections, results are mixed. Some studies have found that these injections improved knee osteoarthritis symptoms for about 12 weeks. However, other research noted potential risks, such as increased knee joint damage over time. Despite this, corticosteroid injections remain a common method for managing joint pain.

Overall, social rewards and game-like features appear safe and effective for increasing physical activity. Corticosteroid injections can provide short-term relief but may carry some long-term risks.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the Exercise Incentives and Corticosteroid Injections trial because it combines social incentives and gamification with standard corticosteroid injections to tackle osteoarthritis in a novel way. Unlike typical treatments that rely solely on medication to relieve pain and inflammation, this approach encourages patients to increase their physical activity through a supportive, game-like platform. This method not only aims to enhance the effectiveness of the corticosteroid injections but also promotes long-term lifestyle changes by motivating patients to achieve step goals. By integrating these elements, the trial seeks to improve both immediate symptom relief and overall joint health more effectively than standard care alone.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Studies have shown that gamification, which uses game-like features to make activities more engaging, can significantly increase exercise levels. For example, participants in exercise programs with game elements were more active than those in regular programs. In this trial, some participants will receive social incentives and gamification to promote exercise, which could help people with knee osteoarthritis (KOA) stay active and manage symptoms.

Research has indicated that corticosteroid injections are a common treatment for knee osteoarthritis. These injections can offer short-term pain relief and improve joint function by reducing swelling. In this trial, participants will receive corticosteroid injections in different sequences. Combining gamification with these injections may help people with KOA move more easily and experience less pain.678910

Who Is on the Research Team?

Joshua F. Baker, MD, MSCE - Center for ...

Joshua Baker, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.
See 3 more

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
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Social Incentives and Gamification, Corticosteroid BAExperimental Treatment2 Interventions
Group II: Social Incentives and Gamification, Corticosteroid ABExperimental Treatment2 Interventions
Group III: No Incentive, Corticosteroid ABActive Control2 Interventions
Group IV: No Incentive, Corticosteroid BAActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Protocol for a multi-center randomized controlled trial to ...In total, 220 participants will be randomized to receive social incentives with gamification (i.e., incorporation of game elements) to ...
Study Details | NCT06488144 | Rehabilitation for Arthritis of ...The investigators will randomize participants to receive social incentives with gamification to promote adherence to prescribed exercises as well as maintenance ...
A Pragmatic Trial to Determine the Benefit of Behaviorally ...This study aims to determine the feasibility of using methods to change behavior that use social incentives and promote physical activity through playing games ...
Effectiveness of Gamification Interventions to Improve Physical ...Our findings showed that the gamification interventions significantly increased moderate-to-vigorous physical activity (MVPA; standardized mean ...
Effectiveness of gamified exercise programs on the level ...Supervised gamified interventions increased the level of physical activity compared to usual supervised exercises. Quality of life was similar between groups.
Evidence suggests that intraarticular corticosteroids are ...Combining data from the MOST and OAI studies, Bucci et al. reported that patients undergoing steroid injections had no greater risk of OA progression nor of ...
Knee Arthritis Made Worse with Steroid InjectionsThe study found that corticosteroid injections led to more knee joint damage over the two-year period than both the control group and those who ...
Use and safety of corticosteroid injections in joints and ...This guideline focuses on the safety and efficacy of corticosteroid joint injections for managing joint chronic pain in adults.
Debate: Intra-articular steroid injections for osteoarthritisIn conclusion, IACS injection has not clearly demonstrated long-term efficacy for treating joint pains in knee or hip OA. IACS injection is not totally safe, ...
Corticosteroid Injections for Symptomatic Treatment of ...Corticosteroid injections demonstrated clinically meaningful improvements in KOA symptoms over 12 weeks of follow-up. These data support larger ...
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