Clinical trial NCT03936088: Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Official title: Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Pain
Lead sponsor: 375th Medical Group, Scott Air Force Base
Sponsor class: FED
Collaborators: name: Mike O'Callaghan Military Hospital
name: 375th Medical Group, Scott Air Force Base
name: Travis AFB 60th Med Group
First posted: 2019-05-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

Detailed description: The investigator's primary aim in this study is to determine if regular use of a mindfulness application improves pain outcomes in adults with knee osteoarthritis. The investigator's secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL) scores predict response to mindfulness treatment in OA. The investigators hypothesize that the use of an mHealth intervention for mindfulness training may be an effective adjunct treatment of chronic knee osteoarthritis pain; specifically, that regular use of a mindfulness application will result in a statistically significant reduction in pain outcomes and improvement in physical function as determined by the KOOS scoring system. The investigators also hypothesize that those with lower baseline self-reported HRQoL scores are more likely to see a greater improvement in their pain and function with use of a mindfulness application than those with higher baseline scores.

Eligibility criteria: \*\*Patients must be able to get care at Nellis, Scott, or Travis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female Active Duty members and DoD beneficiaries ages 18-74 years
* Meet criteria for symptomatic knee osteoarthritis according to the American College of Rheumatology (pain on more than half of the days of the past month during at least one of the following activities: walking, ascending or descending stairs, standing upright, or lying in bed at night)
* Demonstrate radiographic evidence of OA, with Kellgren and Lawrence (KL) Grade ≥1 as determined by Lead Site Investigator at each study location
* Must have access to a smartphone with enough memory to download the app My Water Balance or the Mindfulness app

Exclusion Criteria:

* Intra-articular corticosteroid injection in the 3 months prior to participation in the study.
* Intra-articular hyaluronic acid/PRP injection in the 6 months prior to participation in the study
* Medical condition contraindicating moderate aerobic exercise as determined by their physician
* History of knee surgery in the past 6 months or previous knee arthroplasty
* Inflammatory joint disease.
* Current Practice of Mindfulness
* Non-English-speaking
* Currently pregnant or planning pregnancy over the study period
* Enrollment in other clinical research study during the study period
* Inability to comply with treatment protocol, including participation in the Rx3 Home Exercise Program.

Primary outcomes:
measure: Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale
timeFrame: 0,12, 26, 52, and 104 weeks
Secondary outcomes:
measure: Change in KOOS subscale scores
timeFrame: 0,12, 26, 52, and 104 weeks
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes
timeFrame: 0,12, 26, 52, and 104 weeks
measure: Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments
timeFrame: 0,12, 26, 52, and 104 weeks
Other outcomes:
Locations:
city: Scott Air Force Base
country: United States
facility: 375th Medical Group
state: Illinois
Study officials:
affiliation: US Air Force
name: Jillian E Sylvester, MD
role: PRINCIPAL_INVESTIGATOR
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