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 (MOVE-OK)

A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Behavioral: Social Incentives and Gamification to Promote Exercise; Behavioral: No Social Incentive applied; Drug: Corticosteroid Injection given in A-B order; Drug: Procedure: Corticosteroid Injection given in B-A order

Detailed Description

Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among Veterans and accounts for high morbidity and high costs for the VA. Management of KOA is challenging as there are few consistently effective treatments other than joint replacement. Importantly, chronic reductions in physical activity in patients with KOA may worsen pain, physical function, and exacerbate the metabolic consequences of obesity. Moreover, the greater mortality observed in symptomatic knee OA populations is likely mediated through its effect on physical activity. The current proposal aims to derive preliminary data to support a large pragmatic trial testing the impact of interventions geared towards improving physical activity and function in KOA patients.

Promoting physical activity has been shown to be helpful in reducing pain and improving function in KOA and other groups. However, promoting behavioral change in the arthritis population is a significant challenge. The group has shown that social incentives [and gamification] derived from concepts from the field of behavioral economics to promote behavioral change and increase physical activity can be both practical and effective in other settings. The investigators' group is studying incentives in patients with inflammatory arthritis with the goal of addressing fatigue, pain, and deficits in physical function. The incentivization of physical activity using this approach represents a novel intervention for the managing symptoms of KOA and to improving overall health.

Analgesic therapies can help KOA patients participate in exercise therapy. However, whether corticosteroid injections, a commonly used medical therapy for KOA pain, has a positive impact of physical activity is unknown and is an additional important question addressed by the current proposal. Despite widespread use, definitive data demonstrating a consistent benefit of corticosteroids are lacking. A large randomized trial recently tested the effects of repeated corticosteroids injections every 3 months for a period of 2 years on patient reported pain as well as progression of disease measured by magnetic resonance imaging (MRI). This study demonstrated no improvement in pain compared to saline injections. In addition, a small but statistically significant decline in cartilage thickness on MRI was observed, raising a concern for side effects. These recent data might suggest that corticosteroid injections result in more harm than good, and may discourage providers from performing this intervention. However, there are critical weaknesses to this study. Pain and function were only assessed at 3-month intervals, while previous trials have suggested that peak benefit is expected at 4-8 weeks. Moreover, the clinical and biologic significance decrease in cartilage thickness is unclear.

The investigators propose to fill these important knowledge gaps with an innovative and efficient pragmatic clinical trial with a factorial and crossover design. A large and definitive practical trial would lead to better understanding of the clinical effectiveness of these interventions, the meaningfulness of their combined impact, and the subgroups that are most likely to derive benefit. This clinical trial will leverage unique resources available through the Penn Center for Innovation to better capture important patient-reported outcomes in real-time through a web-based platform. The study will also test the feasibility of a crossover and factorial design to improve efficiency and reduce confounding. Each patient will receive each intervention (saline, corticosteroids) in random order over 1 year. A factorial design will be employed and will randomize participants to receive social incentives with gamification to promote increases in their physical activity. To accomplish these aims, the investigators will utilize innovative mobile applications for smart phones and wearable activity trackers through the Way-to-Health platform and assess, in real time, the impact of the intervention on patient-reported function and pain as well as physical activity. The technology will allow for the recording of outcomes as they occur, between clinic visits, thereby avoiding information bias due to poor recall. It will also provide real-time assessment of symptoms, providing granular assessments of response over time.

Aim 1: To determine whether an incentive based on behaviorally-enhanced gamification can improve physical activity among patients with KOA and reduce self-reported pain and disability. The intervention will result in sustained improvements in average daily step counts over 10 months.

Aim 2: To determine if corticosteroid injections can reduce pain and disability in patients with KOA when compared to lidocaine only. Participants will report improvements in self-reported pain and disability, and improvements in quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joshua F Baker, MD MSCE; Phone Number: (215) 823-5800; Email: Joshua.Baker@va.gov
• Study Contact Backup: Name: William T Leach, MA BS; Phone Number: 204630 (215) 823-4630; Email: William.Leach@va.gov

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Recruiting
      • Washington DC VA Medical Center, Washington, DC
      • Contact: Mercedes Quinones, MD; Phone Number: 202-745-8000; Email: Mercedes.Quinones@va.gov
  • Nebraska
    • Omaha, Nebraska, United States, 68105-1873
      • Recruiting
      • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
      • Contact: Bryant England, MD; Phone Number: 402-888-6728; Email: Bryant.England@va.gov
      • Contact: Bridget Kramer; Email: bridget.kramer@unmc.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4551
      • Recruiting
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
      • Contact: Joshua F Baker, MD MSCE; Phone Number: 215-823-5800; Email: Joshua.Baker@va.gov
      • Principal Investigator: Joshua F. Baker, MD MSCE
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Katherine D Wyshan, MD; Phone Number: 206-764-2251; Email: Katherine.Wysham@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Incentives and Gamification, Corticosteroid AB; 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; The intervention will provide social incentives and gamification to promote physical activity.; Drug: Corticosteroid Injection given in A-B order; 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.
Active Comparator: No Incentive, Corticosteroid AB; Participants will only receive reminders to sync their activity monitor. The participants will receive injections in A-B order (corticosteroids, then lidocaine only)	Behavioral: No Social Incentive applied; No social incentive will be applied; Drug: Corticosteroid Injection given in A-B order; 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.
Experimental: Social Incentives and Gamification, Corticosteroid BA; 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; The intervention will provide social incentives and gamification to promote physical activity.; Drug: Procedure: Corticosteroid Injection given in B-A order; 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.
Active Comparator: No Incentive, Corticosteroid BA; 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; No social incentive will be applied; Drug: Procedure: Corticosteroid Injection given in B-A order; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 3 months (for injection intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS pain intensity score	Assessed by survey at 2 week intervals. Scores range from 3-15 and are converted to T-Scores. A high score represents greater pain.	Measured bi-weekly over 3-10 months (3 for injection intervention and 10 for exercise intervention)
Change in PROMIS Fatigue	Assessed by survey at 4 week intervals	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)	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 10 months (for exercise intervention)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joshua F. Baker, MD MSCE, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Arthritis; physical activity; Osteoarthritis; pain; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; disability; corticosteroid injection; Osteoarthritis, Knee; behavioral incentives
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: F3644-R; RX003644-01A1 (Other Grant/Funding Number: VA RR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sets will be available through a formal request process through the PI and co-investigators. Data will not be shared without the approval of CVCVAMC IRB. When shared, data will be de-identified and anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes