Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale
研究概览
简要总结
This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**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
排除标准
- •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.
结局指标
主要结局
Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale
时间窗: 0,12, 26, 52, and 104 weeks
The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).
次要结局
- Change in KOOS subscale scores(0,12, 26, 52, and 104 weeks)
- Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes(0,12, 26, 52, and 104 weeks)
- Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments(0,12, 26, 52, and 104 weeks)
研究者
jilliansylvester
Principal Investigator
375th Medical Group, Scott Air Force Base