Arthritis Ease Study
Completed · Phase 1/Phase 2
Conditions studied: Knee Osteoarthritis, Chronic Pain, Kinesiophobia
In brief
The goal of this clinical trial is to test using a pain and anxiety reduction phone application in older adults with knee osteoarthritis and chronic pain. The main questions it seeks to answer are: 1. How acceptable is using a phone app in older adults with knee osteoarthritis and chronic pain to lower pain, pain stress and reduce fear of movement? 2. What are the effects of combining biofeedback with a virtual reality nature scene and paced breath training to increase heart rate variability on pain and anxiety among older adults with knee osteoarthritis? 3. What is the role of self-regulation and body awareness in predicting or strengthening the effect of combining virtual reality, heart rate variability biofeedback in older adults with knee osteoarthritis?. Participants will be asked to: 1. use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks. 2. receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase. 3. complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use. 4. complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.
Key facts
- Study ID
- NCT05721352
- Run by
- Arizona State University
- People needed
- 36
- Starts
- 2022-09-15
- Expected to finish
- 2024-09-11
- Last updated by the study team
- 2024-09-23
Who can join
Age: 45 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English speaking adults
- Diagnosed osteoarthritis of the knee(s)
- smart phone access
- Pain scale rating of 4-10 on the numerical pain rating scale (0- 10) \\
- Pain duration of 3 months or greater
- Score of 15 or greater on the Tampa Scale of Kinesiophobia (fear of movement) scale
- Eligibility includes:
- Willingness to engage in the study for 8 weeks
- Being available for 1-3 phone calls for data collection at pre- and post-8-week intervention and at 4 weeks post-intervention conclusion
You may not qualify if…
- Self-report of: acute illness,
- Cancer
- HIV
- Systemic inflammatory disease (rheumatoid arthritis, lupus)
- History of neurologic disease, seizure disorder,
- Current or history of mental illness illness with hallucinations
- Motion sickness or vestibular disorders
- Acute or chronic respiratory disease
- Dysrhythmic heart disease
- Beta or calcium channel blocker medication use
- Monovision \\\\
- Current use of Heart rate variability training activities will also be excluded
Where it is running
- Arizona State University — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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