Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain

VRx Medical

Status: Completed

Conditions: Chronic Pain; Opioid Use; Arthritis Hand

Treatments: Other: Standard of care; Device: Nottingham AR smartphone app with active intervention

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; NIH

Identifiers

NCT05634291

H210106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Standard of Care followed by AR digital treatment

Experimental group

Description:

Standard of care period without active intervention followed by Digital treatment with active intervention

Treatment:

Other: Standard of care

Device: Nottingham AR smartphone app with active intervention