Back to resultsEffects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
Primary Purpose
Chronic Pain, Arthritis Hand, Opioid Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care
Nottingham AR smartphone app with active intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Augmented Reality, Smartphone application, Digital Therapeutic
Eligibility Criteria
Inclusion Criteria: Male and female adults ages 21-80 Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily 4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation. Exclusion Criteria: Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease) Current active alcohol or substance use disorder as evidenced from medical record Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation fMRI exclusion only: Any factors that would prevent participation in fMRI
Sites / Locations
- VA San Diego Healthcare System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard of Care followed by AR digital treatment
Arm Description
Standard of care period without active intervention followed by Digital treatment with active intervention
Outcomes
Primary Outcome Measures
The Pain, Enjoyment of Life and General Activity scale (PEG)
PEG is a three-Item scale assessing pain intensity and interference. Scale is from 0 (no pain) to 10 (pain as bad as you can imagine).
Milligrams of Morphine Equivalent (MME)
MME is a standard measure of opioid use
Secondary Outcome Measures
Resting State brain imaging data
fMRI compare pre- to post treatment - imaging data to show hyperactivities and enhanced functional connectivity in supraspinal regions associated with the affective aspect of pain perception.
Non-opioid pain medicine usage
Pain medicine usage will be tracked for dose and frequency.
Pain Disability Index (PDI)
PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain.
Patient Health Questionnaire (PHQ-9)
PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity
Full Information
NCT ID
NCT05634291
First Posted
November 21, 2022
Last Updated
July 22, 2023
Sponsor
VRx Medical Inc
Collaborators
National Institute on Drug Abuse (NIDA), San Diego Veterans Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT05634291
Brief Title
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
Official Title
Effects of the Nottingham Arthritis App for Arthritis Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VRx Medical Inc
Collaborators
National Institute on Drug Abuse (NIDA), San Diego Veterans Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.
Detailed Description
This is a run-in design, feasibility study that uses the enrolled participants as their own control. After consenting to join the study, for the first 30 days, participants will be on their current Standard of Care (SoC). Then, for the next 30 days, the same group of participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment period measures of opioid use and pain, quality of life measures will be administered and measured. Additionally, for qualifying participants, Pre- and Post-treatment functional Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy affects neuroplastic changes in the supraspinal pain network associated with the therapy sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Arthritis Hand, Opioid Use
Keywords
Augmented Reality, Smartphone application, Digital Therapeutic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care followed by AR digital treatment
Arm Type
Experimental
Arm Description
Standard of care period without active intervention followed by Digital treatment with active intervention
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care as prescribed by healthcare provider.
Intervention Type
Device
Intervention Name(s)
Nottingham AR smartphone app with active intervention
Intervention Description
AR software treatment delivered by smartphone app and developed by VRx Medical (VRx) using established principles of illusion therapies (e.g. mirror therapy) for pain management.
Primary Outcome Measure Information:
Title
The Pain, Enjoyment of Life and General Activity scale (PEG)
Description
PEG is a three-Item scale assessing pain intensity and interference. Scale is from 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame
Change from baseline to day 30
Title
Milligrams of Morphine Equivalent (MME)
Description
MME is a standard measure of opioid use
Time Frame
Change from baseline to day 30
Secondary Outcome Measure Information:
Title
Resting State brain imaging data
Description
fMRI compare pre- to post treatment - imaging data to show hyperactivities and enhanced functional connectivity in supraspinal regions associated with the affective aspect of pain perception.
Time Frame
Change from baseline to day 30
Title
Non-opioid pain medicine usage
Description
Pain medicine usage will be tracked for dose and frequency.
Time Frame
Change from baseline to day 30
Title
Pain Disability Index (PDI)
Description
PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain.
Time Frame
Change from baseline to day 30
Title
Patient Health Questionnaire (PHQ-9)
Description
PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity
Time Frame
Change from baseline to day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female adults ages 21-80
Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily
4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.
Exclusion Criteria:
Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
Current active alcohol or substance use disorder as evidenced from medical record
Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
fMRI exclusion only: Any factors that would prevent participation in fMRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rutledge, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
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