A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee Marching On for Veterans With Osteoarthritis of the Knee

NCT05035810 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: F3644-RRX003644-01A1
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Keywords

corticosteroid injection; physical activity; pain; disability; behavioral incentives; Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Outcome Measures

Primary Outcomes (2)

• Percent change from baseline in weekly average steps per day

  Steps measured by a wearable activity monitor

  Measured weekly over 10 months (for exercise intervention)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  KOOS assessed by survey at 2 week intervals. KOOS scores range from 0 to 100 with 0 representing worse knee problems and 100 representing no knee problems.

  Measured bi-weekly over the first 3 months (for injection intervention)

Secondary Outcomes (3)

• Change in PROMIS pain intensity score

  Measured bi-weekly over 3-10 months (3 for injection intervention and 10 for exercise intervention)

• Change in PROMIS Fatigue

  Measured every 4 weeks over 3-10 months (3 for injection intervention and 10 for exercise intervention)

• Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS)

  Measured bi-weekly over 10 months (for exercise intervention)

Study Arms (4)

Social Incentives and Gamification, Corticosteroid AB

EXPERIMENTAL

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)

Behavioral: Social Incentives and Gamification to Promote Exercise; Drug: Corticosteroid Injection given in A-B order

No Incentive, Corticosteroid AB

ACTIVE COMPARATOR

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

Drug: Corticosteroid Injection given in A-B order; Behavioral: No Social Incentive applied

Social Incentives and Gamification, Corticosteroid BA

EXPERIMENTAL

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)

Behavioral: Social Incentives and Gamification to Promote Exercise; Drug: Procedure: Corticosteroid Injection given in B-A order

No Incentive, Corticosteroid BA

ACTIVE COMPARATOR

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

Behavioral: No Social Incentive applied; Drug: Procedure: Corticosteroid Injection given in B-A order

Interventions

Social Incentives and Gamification to Promote Exercise BEHAVIORAL

The intervention will provide social incentives and gamification to promote physical activity.

Social Incentives and Gamification, Corticosteroid AB; Social Incentives and Gamification, Corticosteroid BA

Corticosteroid Injection given in A-B order DRUG

The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.

No Incentive, Corticosteroid AB; Social Incentives and Gamification, Corticosteroid AB

No Social Incentive applied BEHAVIORAL

No social incentive will be applied

No Incentive, Corticosteroid AB; No Incentive, Corticosteroid BA

Procedure: Corticosteroid Injection given in B-A order DRUG

The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.

No Incentive, Corticosteroid BA; Social Incentives and Gamification, Corticosteroid BA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intra-articular hardware or other contraindication to joint injection
• Lack of smart phone
• Acute exacerbation of osteoarthritis or knee pain
• Comorbid condition that precludes safe exercise

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1873, United States

Location

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

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

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Leach W, Doherty C, Olave M, England BR, Wysham K, Kerr G, Quinones M, Ogdie A, White D, Neogi T, Scanzello CR, Baker JF. Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK). Trials. 2022 Jul 27;23(1):604. doi: 10.1186/s13063-022-06529-w.

  PMID: 35897080 BACKGROUND

• Gillcrist RL, Doherty CR, Olave M, Bonilla J, England BR, Wysham K, Quinones M, Scanzello CR, Ogdie A, White DK, Neogi T, Baker JF. A Remote Behaviorally Designed Intervention to Promote Physical Activity in Patients With Knee Osteoarthritis: Results of a Pilot Randomized Clinical Trial. J Clin Rheumatol. 2024 Dec 1;30(8):336-339. doi: 10.1097/RHU.0000000000002148. Epub 2024 Oct 16.

  PMID: 39412672 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Pain; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joshua F. Baker, MD MSCE

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is not possible to blind participants to the social incentives they will receive. For the injection aspect of the study, both the investigator and participant will be unaware of the injection being given and the syringe will be covered to obscure the view of the patient.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are randomized with a software application to receive social incentives to promote physical activity. They will also be randomized to receive corticosteroid injections in a crossover design.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: March 14, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)