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Recruiting
NCT05721352
Arthritis Ease Study
Conditions: Knee Osteoarthritis, Chronic Pain, Kinesiophobia
Sex: All
Ages: 45 Years – 74 Years
Phase: EARLY_PHASE1
Enrollment: 24
Sponsor: Arizona State University
Location: United States
Summary
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: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?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?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:use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks.receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase.complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use.complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.
Eligibility Criteria
Inclusion Criteria:English speaking adultsDiagnosed osteoarthritis of the knee(s)smart phone accessPain scale rating of 4-10 on the numerical pain rating scale (0- 10) \Pain duration of 3 months or greaterScore of 15 or greater on the Tampa Scale of Kinesiophobia (fear of movement) scaleEligibility includes:Willingness to engage in the study for 8 weeksBeing available for 1-3 phone calls for data collection at pre- and post-8-week intervention and at 4 weeks post-intervention conclusionExclusion criteria:Self-report of: acute illness,CancerHIVSystemic inflammatory disease (rheumatoid arthritis, lupus)History of neurologic disease, seizure disorder,Current or history of mental illness illness with hallucinationsMotion sickness or vestibular disordersAcute or chronic respiratory diseaseDysrhythmic heart diseaseBeta or calcium channel blocker medication useMonovision \\Current use of Heart rate variability training activities will also be excluded
Source: ClinicalTrials.gov (NCT05721352). StuddyBuddy aggregates publicly available trial information.