Clinical trial NCT05721352: Arthritis Ease Study
Official title: Arthritis Pain Reduction in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Chronic Pain
Kinesiophobia
Keywords: Heart Rate Variability
Biofeedback
Virtual Reality
Body awareness
Self regulation
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group pre-post intervention design
Primary purpose: SUPPORTIVE_CARE

Brief 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:

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Adherence Measure
timeFrame: 8 weeks
measure: Satisfaction Measure
timeFrame: 8-12 Weeks
Secondary outcomes:
measure: Patient-reported outcomes measurement information -29 v2.0 system-29 Profile v2.0
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Multidimensional Assessment of Somatic Sense Scale
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Heart Rate
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Heart rate variability data
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Stanford Brief Activity Survey
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Severity Index (WOMAC- Stiffness scale
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Customized Technology Adoption Survey
timeFrame: 12th Week
measure: Post-Intervention Qualitative Interview
timeFrame: Between 8th and 12th Week
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Linda Larkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: