---
title: Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
nct_id: NCT03936088
overall_status: COMPLETED
phase: NA
sponsor: jilliansylvester
study_type: INTERVENTIONAL
primary_condition: Osteo Arthritis Knee
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03936088.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03936088"
ct_last_update_post_date: 2022-09-13
last_seen_at: "2026-05-12T06:15:03.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

**NCT ID:** [NCT03936088](https://clinicaltrials.gov/study/NCT03936088)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** jilliansylvester
- **Collaborators:** Mike O'Callaghan Military Hospital, 375th Medical Group, Scott Air Force Base, Travis AFB 60th Med Group
- **Conditions:** Osteo Arthritis Knee, Pain
- **Start Date:** 2019-05-02
- **Completion Date:** 2022-09-12
- **CT.gov Last Update:** 2022-09-13

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 74 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
\*\*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.
```

## Arms

- **Intervention with Mindfulness App (Headspace)** (EXPERIMENTAL) — Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
- **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.

## 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.
- **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

- **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

- **Change in KOOS subscale scores** _(time frame: 0,12, 26, 52, and 104 weeks)_
- **Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes** _(time frame: 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)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `locations.375th medical group|scott air force base|illinois|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03936088*  
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