Knee OsteoarthritisPhase 1/2NCT05721352
Arthritis Ease Study
A Phase 1/2 study testing Virtual Reality Nature scene plus heart rate variability biofeedback phone application in people with Knee Osteoarthritis and Chronic Pain, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Knee Osteoarthritis, Chronic Pain, Kinesiophobia
- What is being tested?
- Virtual Reality Nature scene plus heart rate variability biofeedback phone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 11 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Arthritis Pain Reduction in Older Adults
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?.
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Chronic Pain, Kinesiophobia
- Being tested
- Virtual Reality Nature scene plus heart rate variability biofeedback phone application
- Keywords
- Heart Rate Variability, Biofeedback, Virtual Reality, Body awareness, Self regulation
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain, Kinesiophobia, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Nature scene plus heart rate variability biofeedback phone applicationBehavioural
phone app for slow- paced breath training with biofeedback in a virtual reality nature scene
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Virtual Reality Nature scene plus heart rate variability biofeedback phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8-12 Weeks
Secondary outcomes (9)
Patient-reported outcomes measurement information -29 v2.0 system-29 Profile v2.0
The Patient-reported outcomes measurement information -29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item (lower score is better) and seven physical and mental health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Each question has a 5 point Likert scale and each domain has a minimum score of 4 and a maximum score of 20,,with higher score being better.is no composite score as individual items are scored within each health domain.
Measured: Baseline, 4, 8 and 12 weeks
Multidimensional Assessment of Somatic Sense Scale
8 Scale (32 items) Self-report measure of dimensions of body awareness and self regulation (noticing, not distracting, not worrying, attention regulation, attention regulation, emotional awareness, body listening, trust and self regulation) Each scale has a 0-5 point Likert Scale with higher numbers being better. The range for each scale score mean is derived and compared to baseline values and indexed mean values..
Minimum and maximum scores depend on the number of items in each domain which ranges from 3-7 items. A minimum score for a domain of 0 (worse) to a maximum of 15 for example and higher numbers are better.
Measured: Baseline, 4, 8 and 12 weeks
Heart Rate
Heart rate data will be measured and compared from pre to post intervention
Measured: Baseline, 4, 8 and 12 weeks
Heart rate variability data
Heart rate variability data collected for spectral analysis (vagal tone)
Time domain analysis of vagal tone:
Root mean squared of successive R-R interval difference change score between baseline and intervention time frames
Frequency analysis of vagal tone:
High frequency heart rate variability
Measured: Baseline, 4, 8 and 12 weeks
Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)
Self report scale of fear avoidance and somatic focus with 11 questions and responses ranging from Strongly disagree (1) to strongly agree (4) on a 4 point Likert Scale. Scores range from a minimum of 11 to a maximum of 44 points with higher scores indicating greater fear of pain, movement, and injury
Measured: Baseline, 4, 8 and 12 weeks
Stanford Brief Activity Survey
2 question- self report of usual daily work and leisure time activity and activity intensity to classify 5 activity levels, ranging from inactive to very hard intensity, using established metabolic equivalents for activity levels.
The first item describes 5 different patterns of on-the-job activity, ranging from mostly sedentary to hard physical labor (such as carrying heavy loads). Similarly, the second item describes 5 patterns of leisure-time activity, ranging from sedentary to regular vigorous activity, such as running, on 5 or more days per week. Respondents select the 1 pattern that best describes their on-the-job activity and the 1 pattern that best describes their leisure-time activity. Each response pattern includes a global statement about the activity and the dimensions of frequency, intensity, time, and type of activity
Measured: Baseline, 4, 8 and 12 weeks
Western Ontario and McMaster Universities Osteoarthritis Severity Index (WOMAC- Stiffness scale
2 Likert Scale questions of self-report joint stiffness The test questions are scored on a scale of 0-4, which correspond to: none (0), mild (1), moderate (2), severe (3), and extreme (4).
The minimum score is 0 and the maximum is 8 and larger scores indicate worse stiffness.
Measured: Baseline, 4, 8 and 12 weeks
Customized Technology Adoption Survey
Modified Technology adoption survey of phone app use.(12 -6 point Likert Scaled questions ranging from 0 Very strongly disagree to very strongly agree ) with larger scores indicating better ease of use, attitude towards use and intent to use. The minimum score is 0 and the maximum score is 72.
Measured: 12th Week
Post-Intervention Qualitative Interview
Semi-structured qualitative interview regarding phone app usability (ease of use), acceptability (satisfaction), pain, fear of pain, physical activity,
Measured: Between 8th and 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Sep 2022
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pre-post intervention design
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Larkey, Arizona State University
- Investigators
- Linda Larkey, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721352
- Sponsor's protocol ID
- 00013939
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthritis Pain Reduction in Older Adults
- ClinicalTrials.gov ID
- NCT05721352
- Acronym / sponsor ID
- 00013939
- Conditions
- Knee Osteoarthritis, Chronic Pain, Kinesiophobia
- Keywords
- Heart Rate Variability, Biofeedback, Virtual Reality, Body awareness, Self regulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pre-post intervention design
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Behavioral: Virtual Reality Nature scene plus heart rate variability biofeedback phone application* 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 |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Self-report of: acute illness,
- Cancer
- HIV
- Systemic inflammatory disease (rheumatoid arthritis, lupus)
- History of neurologic disease, seizure disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Nature scene plus heart rate variability biofeedback phone applicationphone app for slow- paced breath training with biofeedback in a virtual reality nature scene | Behavioural | Single Arm Study |
Primary outcome
Adherence Measure
Time frame: 8 weeks
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 Measure
Time frame: 8-12 Weeks
Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying
9 secondary outcomes
Patient-reported outcomes measurement information -29 v2.0 system-29 Profile v2.0
Time frame: Baseline, 4, 8 and 12 weeks
Multidimensional Assessment of Somatic Sense Scale
Time frame: Baseline, 4, 8 and 12 weeks
Heart Rate
Time frame: Baseline, 4, 8 and 12 weeks
Heart rate variability data
Time frame: Baseline, 4, 8 and 12 weeks
Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)
Time frame: Baseline, 4, 8 and 12 weeks
Stanford Brief Activity Survey
Time frame: Baseline, 4, 8 and 12 weeks
Western Ontario and McMaster Universities Osteoarthritis Severity Index (WOMAC- Stiffness scale
Time frame: Baseline, 4, 8 and 12 weeks
Customized Technology Adoption Survey
Time frame: 12th Week
Post-Intervention Qualitative Interview
Time frame: Between 8th and 12th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Larkey, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Virtual Reality Nature scene plus heart rate variability biofeedback phone application in people with Knee Osteoarthritis and Chronic Pain, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Measure (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.