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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936088
• Other study ID #: FWH20190033H
• Status: Completed
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: September 12, 2022

Study information

• Verified date: September 2022
• Source: 375th Medical Group, Scott Air Force Base
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

**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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	375th Medical Group	Scott Air Force Base	Illinois

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Turner JA, Anderson ML, Balderson BH, Cook AJ, Sherman KJ, Cherkin DC. Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial. Pain. 2016 Nov;157(11):2434-2444. doi: 10.1097/j.pain.0000000000000635. — View Citation

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Zangi HA, Mowinckel P, Finset A, Eriksson LR, Høystad TØ, Lunde AK, Hagen KB. A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):911-7. doi: 10.1136/annrheumdis-2011-200351. Epub 2011 Dec 20. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in KOOS subscale scores	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	Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes	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
Secondary	Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments	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