Summary

Eligibility
for people ages 21-80 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Thomas Rutledge, PhD (ucsd)

Description

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.

Official Title

Effects of the Nottingham Arthritis App for Arthritis Pain

Details

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.

Keywords

Chronic Pain, Arthritis Hand, Opioid Use, Augmented Reality, Smartphone application, Digital Therapeutic, Arthritis, Nottingham AR smartphone app with active intervention

Eligibility

You can join if…

Open to people ages 21-80

  1. Male and female adults ages 21-80
  2. 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.

You CAN'T join if...

  1. Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
  2. Current active alcohol or substance use disorder as evidenced from medical record
  3. Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
  4. Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
  5. fMRI exclusion only: Any factors that would prevent participation in fMRI

Location

  • VA San Diego Healthcare System accepting new patients
    San Diego California 92161 United States

Lead Scientist at University of California Health

  • Thomas Rutledge, PhD (ucsd)
    Biography Dr. Rutledge is a Professor in the Department of Psychiatry at UCSD. He received his Bachelor’s degree from the University of Alaska, Anchorage in 1994, and subsequently completed Master’s and Doctoral studies in clinical psychology at the University of British Columbia.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VRx Medical Inc
ID
NCT05634291
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated