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

Primary Purpose

Osteo Arthritis Knee, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention -- "Headspace" mindfulness application
Control -- "My Water Balance" application
Sponsored by
jilliansylvester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**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.

Sites / Locations

  • 375th Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention with Mindfulness App (Headspace)

Control with Water App (My Water Balance)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
April 30, 2019
Last Updated
September 12, 2022
Sponsor
jilliansylvester
Collaborators
Mike O'Callaghan Military Hospital, 375th Medical Group, Scott Air Force Base, Travis AFB 60th Med Group
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1. Study Identification

Unique Protocol Identification Number
NCT03936088
Brief Title
Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Official Title
Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
jilliansylvester
Collaborators
Mike O'Callaghan Military Hospital, 375th Medical Group, Scott Air Force Base, Travis AFB 60th Med Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention with Mindfulness App (Headspace)
Arm Type
Experimental
Arm Description
Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
Arm Title
Control with Water App (My Water Balance)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intervention -- "Headspace" mindfulness application
Intervention Description
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 Type
Device
Intervention Name(s)
Control -- "My Water Balance" application
Intervention Description
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 Outcome Measure Information:
Title
Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale
Description
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).
Time Frame
0,12, 26, 52, and 104 weeks
Secondary Outcome Measure Information:
Title
Change in KOOS subscale scores
Description
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).
Time Frame
0,12, 26, 52, and 104 weeks
Title
Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes
Description
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.
Time Frame
0,12, 26, 52, and 104 weeks
Title
Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments
Description
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.
Time Frame
0,12, 26, 52, and 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
**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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian E Sylvester, MD
Organizational Affiliation
US Air Force
Official's Role
Principal Investigator
Facility Information:
Facility Name
375th Medical Group
City
Scott Air Force Base
State/Province
Illinois
ZIP/Postal Code
62225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan on sharing data
Citations:
PubMed Identifier
29335232
Citation
Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
Results Reference
background
PubMed Identifier
28961631
Citation
Ball EF, Nur Shafina Muhammad Sharizan E, Franklin G, Rogozinska E. Does mindfulness meditation improve chronic pain? A systematic review. Curr Opin Obstet Gynecol. 2017 Dec;29(6):359-366. doi: 10.1097/GCO.0000000000000417.
Results Reference
background
PubMed Identifier
27002445
Citation
Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
Results Reference
background
PubMed Identifier
19941676
Citation
Chiesa A, Serretti A. A systematic review of neurobiological and clinical features of mindfulness meditations. Psychol Med. 2010 Aug;40(8):1239-52. doi: 10.1017/S0033291709991747. Epub 2009 Nov 27.
Results Reference
background
PubMed Identifier
24553908
Citation
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
Results Reference
background
PubMed Identifier
27014966
Citation
Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.
Results Reference
background
PubMed Identifier
27642370
Citation
Fish J, Brimson J, Lynch S. Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Mindfulness (N Y). 2016;7(5):1011-1023. doi: 10.1007/s12671-016-0548-2. Epub 2016 Jun 2.
Results Reference
background
PubMed Identifier
21542535
Citation
Fox SD, Flynn E, Allen RH. Mindfulness meditation for women with chronic pelvic pain: a pilot study. J Reprod Med. 2011 Mar-Apr;56(3-4):158-62.
Results Reference
background
PubMed Identifier
27015600
Citation
Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692.
Results Reference
background
Citation
IHS Markit, The Complexities of Physician Supply and Demand 2017 Update: Projections from 2016 to 2030. Prepared for the Association of American Medical Colleges. Washington, DC: Association of American Medical Colleges. Accessed November 2018.
Results Reference
background
PubMed Identifier
29178176
Citation
Jafarzadeh SR, Felson DT. Updated Estimates Suggest a Much Higher Prevalence of Arthritis in United States Adults Than Previous Ones. Arthritis Rheumatol. 2018 Feb;70(2):185-192. doi: 10.1002/art.40355. Epub 2018 Jan 3.
Results Reference
background
PubMed Identifier
19950287
Citation
Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009 Dec;60(12):3546-53. doi: 10.1002/art.24984.
Results Reference
background
PubMed Identifier
25376753
Citation
la Cour P, Petersen M. Effects of mindfulness meditation on chronic pain: a randomized controlled trial. Pain Med. 2015 Apr;16(4):641-52. doi: 10.1111/pme.12605. Epub 2014 Nov 7.
Results Reference
background
PubMed Identifier
27349461
Citation
Lee AC, Harvey WF, Price LL, Morgan LPK, Morgan NL, Wang C. Mindfulness is associated with psychological health and moderates pain in knee osteoarthritis. Osteoarthritis Cartilage. 2017 Jun;25(6):824-831. doi: 10.1016/j.joca.2016.06.017. Epub 2016 Jun 24.
Results Reference
background
PubMed Identifier
28506776
Citation
Lee AC, Harvey WF, Price LL, Han X, Driban JB, Wong JB, Chung M, McAlindon TE, Wang C. Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. Arch Phys Med Rehabil. 2017 Nov;98(11):2265-2273.e1. doi: 10.1016/j.apmr.2017.04.014. Epub 2017 May 12.
Results Reference
background
PubMed Identifier
28510679
Citation
McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang M, Ward RJ. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2017 May 16;317(19):1967-1975. doi: 10.1001/jama.2017.5283.
Results Reference
background
PubMed Identifier
18759314
Citation
Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
Results Reference
background
PubMed Identifier
29056773
Citation
Nazarinasab M, Motamedfar A, Moqadam AE. Investigating mental health in patients with osteoarthritis and its relationship with some clinical and demographic factors. Reumatologia. 2017;55(4):183-188. doi: 10.5114/reum.2017.69778. Epub 2017 Aug 31.
Results Reference
background
PubMed Identifier
27959716
Citation
Nissen SE, Yeomans ND, Solomon DH, Luscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13.
Results Reference
background
PubMed Identifier
26488691
Citation
Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
Results Reference
background
PubMed Identifier
27257859
Citation
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.
Results Reference
background
PubMed Identifier
26818413
Citation
Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.
Results Reference
background
PubMed Identifier
28880733
Citation
Wang SX, Ganguli AX, Bodhani A, Medema JK, Reichmann WM, Macaulay D. Healthcare resource utilization and costs by age and joint location among osteoarthritis patients in a privately insured population. J Med Econ. 2017 Dec;20(12):1299-1306. doi: 10.1080/13696998.2017.1377717. Epub 2017 Sep 26.
Results Reference
background
PubMed Identifier
27339668
Citation
Xie F, Kovic B, Jin X, He X, Wang M, Silvestre C. Economic and Humanistic Burden of Osteoarthritis: A Systematic Review of Large Sample Studies. Pharmacoeconomics. 2016 Nov;34(11):1087-1100. doi: 10.1007/s40273-016-0424-x.
Results Reference
background
PubMed Identifier
22186709
Citation
Zangi HA, Mowinckel P, Finset A, Eriksson LR, Hoystad TO, 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.
Results Reference
background
PubMed Identifier
18540734
Citation
Zautra AJ, Davis MC, Reich JW, Nicassario P, Tennen H, Finan P, Kratz A, Parrish B, Irwin MR. Comparison of cognitive behavioral and mindfulness meditation interventions on adaptation to rheumatoid arthritis for patients with and without history of recurrent depression. J Consult Clin Psychol. 2008 Jun;76(3):408-421. doi: 10.1037/0022-006X.76.3.408.
Results Reference
background

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

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