Arthritis Ease Study
CompletedPhase 1, Phase 2NCT05721352
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Arthritis Pain Reduction in Older Adults
- Interventions
- Behavioral: Virtual Reality Nature scene plus heart rate variability biofeedback phone application
- Sponsor
- Arizona State University
- Start date
- 2022-09-15
- Primary completion
- 2024-09-11
- Sex
- All
- Age range
- from 45 Years to 74 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05721352