Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Pain; Osteo Arthritis Knee
• Interventions: Device: Intervention -- "Headspace" mindfulness application; Device: Control -- "My Water Balance" application

• Registration Number: NCT03936088
• Lead Sponsor: jilliansylvester

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.

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study Start: 2019-05-02
• Study First Posted: 2019-05-03
• Status Verified: 2022-09
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with Mindfulness App (Headspace)	Intervention -- "Headspace" mindfulness application	Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
Control with Water App (My Water Balance)	Control -- "My Water Balance" application	Patient education regarding osteoarthritis, its natural history, and common treatments plus the My Water Balance (control) app and provided an in-person demonstration on how to use it.

Primary Outcome Measures

Name	Time	Method
Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale	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).

Secondary Outcome Measures

Name	Time	Method
Change in KOOS subscale scores	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).
Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes	0,12, 26, 52, and 104 weeks	The FFMQ-15 is designed to provide a quantitative evaluation of mindfulness. It is based on five independently developed mindfulness questionnaires.The questionnaire has 39 items. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments	0,12, 26, 52, and 104 weeks	The SF-12 is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.

Trial Locations

Locations (1)

375th Medical Group; 🇺🇸 Scott Air Force Base, Illinois, United States