Arthritis Ease Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 45 Years - 74 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arizona State University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Linda Larkey, PhD
Principal Investigator Affiliation Arizona State University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Chronic Pain, Kinesiophobia
Additional Details

Purpose: This single-group pre-post intervention design, study will explore the feasibility of using a multicomponent phone-based app for 8 weeks to reduce pain, pain stress effects, decreased heart rate variability and fear of movement in 24 older adults with knee osteoarthritis and to examine sustained use and or effects at 4 weeks after intervention period. Aim 1 Evaluate the feasibility (adherence and satisfaction) of a multicomponent phone app combining virtual reality and heart rate variability biofeedback for use in older adults with knee osteoarthritis and chronic pain and gain descriptive evaluations of the experience in exit interviews. Adherence: The adherence benchmark will be 80% of participants will participate at least 5 days per week during the initial 8-week intervention period. Adherence will be examined (not benchmarked) during the 4-week follow-up period. Satisfaction: Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying. Aim 2 Evaluate the preliminary effects of multicomponent phone app use (5 days a week for 8 weeks) in older adults with knee osteoarthritis, in relation to pain, pain stress effects, and fear of movement (kinesiophobia), and examine sustained use patterns and effects with only reminders from the app during the 4-week follow-up period. Aim 3: Examine the role of body awareness and self-regulation to moderate (predict) or mediate (strengthen) the effect of a virtual reality nature scene and heart rate variability biofeedback phone application in older adults with knee osteoarthritis.

Arms & Interventions


Experimental: Single Arm Study

All participants will receive access to the phone application with a virtual reality headset and heart rate variability Bluetooth ear sensor. Participants will be instructed to download a free phone app Elite Heart Rate Variability, login using study provided de-identified research email address, pair the Bluetooth ear sensor and record a five-minute resting heart rate variability reading at baseline and each time point of the study prior to beginning intervention. Participants will be asked to use the intervention phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks. For the first 8 weeks, participants will receive brief, daily texts encouraging participation in the smart phone application. During weeks 9 through 12, will receive relaxation reminders daily via text to determine if use is sustained past the intervention phase


Behavioral: - Virtual Reality Nature scene plus heart rate variability biofeedback phone application

phone app for slow- paced breath training with biofeedback in a virtual reality nature scene

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona State University, Phoenix, Arizona




Arizona State University

Phoenix, Arizona, 85005

Site Contact

Linda Larkey, PhD

[email protected]