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

NCT03936088 | Completed

• 1 other identifier: FWH20190033H
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteo Arthritis Knee; Pain

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• 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

Study Arms (2)

Intervention with Mindfulness App (Headspace)

EXPERIMENTAL

Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.

Device: Intervention -- "Headspace" mindfulness application

Control with Water App (My Water Balance)

ACTIVE COMPARATOR

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

Interventions

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.

Intervention with Mindfulness App (Headspace)

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.

Control with Water App (My Water Balance)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

375th Medical Group

Scott Air Force Base, Illinois, 62225, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jillian E Sylvester, MD

  US Air Force

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 3, 2019
• Study Start: May 2, 2019
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)