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Completed

NCT Number: NCT03936088

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

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

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

375th Medical Group

Scott Air Force Base, Illinois, 62225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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.

Treatment and study plan

Intervention -- "Headspace" mindfulness application

Device

Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.

Control -- "My Water Balance" application

Device

My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in KOOS subscale scores

    Time frame: 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).

  2. Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes

    Time frame: 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.

  3. Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

jilliansylvester

Fed

Collaborators

  • 375th Medical Group, Scott Air Force Base
  • Mike O'Callaghan Military Hospital
  • Travis AFB 60th Med Group

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 3, 2019
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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