NCT05634291

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

Effects of the Nottingham Arthritis App for Arthritis Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: VRx Medical Inc · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pain
• Arthritis Hand
• Opioid Use

Interventions

Type	Name	Description
OTHER	Standard of care	Standard of care as prescribed by healthcare provider.
DEVICE	Nottingham 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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-06-16
• Completion: 2023-07-21
• First posted: 2022-12-02
• Last updated: 2023-07-25

Locations

1 site across 1 country: United States