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A Pragmatic Trial To Determine the Benefit of Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee (MOVE-OK)

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ClinicalTrials.gov Identifier: NCT03835910
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Behavioral: Social Incentives and Gamification to Promote Exercise Procedure: Corticosteroid Injection given in A-B order Behavioral: No Social Incentive applied Procedure: Corticosteroid Injection given in B-A order Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: It is not possible to blind participants to the social incentives they will receive. For the injection aspect of the study, the investigator will be aware of the injection being given but the syringe will be covered to obscure the view of the patient.
Primary Purpose: Treatment
Official Title: A Pragmatic Trial to Determine the Benefit of Exercise Incentives and Corticosteroid Injections for Osteoarthritis of the Knee
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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.

Procedure: 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)

Procedure: 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.

Behavioral: No Social Incentive applied
No social incentive will be applied

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.

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

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.




Primary Outcome Measures :
  1. Percent change from baseline in weekly average steps per day [ Time Frame: Measured weekly over 3-10 months ]
    Steps measured by a wearable activity monitor


Secondary Outcome Measures :
  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Measured bi-weekly over 3-10 months ]
    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.

  2. Change in PROMIS pain intensity score [ Time Frame: Measured bi-weekly over 3-10 months ]
    Assessed by survey at 2 week intervals. Scores range from 3-15 and are converted to T-Scores. A high score represents greater pain.

  3. Change in PROMIS Fatigue [ Time Frame: Measured every 4 weeks over 3-10 months ]
    Assessed by survey at 4 week intervals



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Unable or unwilling to identify a social sponsor
  • Comorbid condition that precludes safe exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835910


Contacts
Contact: Joshua F Baker, MD MSCE (215) 823-5800 Joshua.Baker@va.gov
Contact: Carla R Scanzello, MD PhD (215) 823-5800 ext 5666 Carla.Scanzello@va.gov

Locations
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lizbeth Novelo    215-823-4240    Lizbeth.Novelo@pennmedicine.upenn.edu   
Contact: Richard A Moore    (215) 823-5800 ext 7916    richard.moore7@va.gov   
Principal Investigator: Joshua F. Baker, MD MSCE         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Joshua F. Baker, MD MSCE Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03835910     History of Changes
Other Study ID Numbers: F3157-P
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
corticosteroid injection
physical activity
pain
disability
behavioral incentives

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action