Arthritis Ease Study

NCT05721352 | Completed Phase 1

• 1 other identifier: 00013939
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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. 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. 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?.
4. 4.use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks.
5. 5.receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase.
6. 6.complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use.
7. 7.complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.

Conditions

Knee Osteoarthritis; Chronic Pain; Kinesiophobia

Keywords

Heart Rate Variability; Biofeedback; Virtual Reality; Body awareness; Self regulation

Outcome Measures

Primary Outcomes (2)

• Adherence Measure

  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

  8 weeks

• Satisfaction Measure

  Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying

  8-12 Weeks

Secondary Outcomes (9)

• Patient-reported outcomes measurement information -29 v2.0 system-29 Profile v2.0

  Baseline, 4, 8 and 12 weeks

• Multidimensional Assessment of Somatic Sense Scale

  Baseline, 4, 8 and 12 weeks

• Heart Rate

  Baseline, 4, 8 and 12 weeks

• Heart rate variability data

  Baseline, 4, 8 and 12 weeks

• Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)

  Baseline, 4, 8 and 12 weeks

Study Arms (1)

Single Arm Study

EXPERIMENTAL

* 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

Interventions

Virtual Reality Nature scene plus heart rate variability biofeedback phone application BEHAVIORAL

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

Single Arm Study

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85005, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Kinesiophobia; Self-Control

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Linda Larkey, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-group pre-post intervention design

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 10, 2023
• Study Start: September 15, 2022
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

US (1)