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

September 12, 2022 updated by: jilliansylvester
This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Scott Air Force Base, Illinois, United States, 62225
        • 375th Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention with Mindfulness App (Headspace)
Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
Device: Intervention -- "Headspace" mindfulness application
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.
Active Comparator: Control with Water App (My Water Balance)
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.
Device: Control -- "My Water Balance" application
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0,12, 26, 52, and 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0,12, 26, 52, and 104 weeks
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.
0,12, 26, 52, and 104 weeks
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.
0,12, 26, 52, and 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

jilliansylvester

Collaborators

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

Investigators

  • Principal Investigator: Jillian E Sylvester, MD, US Air Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20190033H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan on sharing data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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