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 |
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Recruitment Status :
Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 18, 2019
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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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
Genetics Home Reference related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
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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. |
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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 |
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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 :
- 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 :
- 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.
- 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.
- 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:
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corticosteroid injection physical activity pain disability behavioral incentives |
Additional relevant MeSH terms:
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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 |