Arthritis Hand, Chronic Pain, Opioid Use
Conditions
Keywords
Augmented Reality, Smartphone application, Digital Therapeutic
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.
Interventions
OTHERStandard of care
Standard of care as prescribed by healthcare provider.
DEVICENottingham AR smartphone app with active intervention
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.
Sponsors
National Institute on Drug Abuse (NIDA)
San Diego Veterans Healthcare System
VRx Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pain, Enjoyment of Life and General Activity scale (PEG) | Change from baseline to day 30 | 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) | Change from baseline to day 30 | MME is a standard measure of opioid use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting State brain imaging data | Change from baseline to day 30 | 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 | Change from baseline to day 30 | Pain medicine usage will be tracked for dose and frequency. |
| Pain Disability Index (PDI) | Change from baseline to day 30 | 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) | Change from baseline to day 30 | PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity |
Countries
United States
Outcome results
None listed