Clinical trial NCT05634291: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Arthritis Hand
Opioid Use
Keywords: Augmented Reality
Smartphone application
Digital Therapeutic
Lead sponsor: VRx Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: San Diego Veterans Healthcare System
First posted: 2022-12-02
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Pain, Enjoyment of Life and General Activity scale (PEG)
timeFrame: Change from baseline to day 30
measure: Milligrams of Morphine Equivalent (MME)
timeFrame: Change from baseline to day 30
Secondary outcomes:
measure: Resting State brain imaging data
timeFrame: Change from baseline to day 30
measure: Non-opioid pain medicine usage
timeFrame: Change from baseline to day 30
measure: Pain Disability Index (PDI)
timeFrame: Change from baseline to day 30
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to day 30
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Thomas Rutledge, PhD
role: PRINCIPAL_INVESTIGATOR
References: