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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| San Diego Veterans Healthcare System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care followed by AR digital treatment | Experimental | Standard of care period without active intervention followed by Digital treatment with active intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | Standard of care as prescribed by healthcare provider. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from baseline to day 30 |
| Milligrams of Morphine Equivalent (MME) | MME is a standard measure of opioid use | Change from baseline to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to day 30 |
| Non-opioid pain medicine usage |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Rutledge, PhD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 22, 2024 | |
| Reset | Sep 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 22, 2024 | Sep 16, 2024 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Nottingham AR smartphone app with active intervention | Device | 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. |
|
Pain medicine usage will be tracked for dose and frequency. |
| Change from baseline to day 30 |
| Pain Disability Index (PDI) | PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain. | Change from baseline to day 30 |
| Patient Health Questionnaire (PHQ-9) | PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity | Change from baseline to day 30 |