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

Not Applicable

Completed

• Conditions: Chronic Pain; Arthritis Hand; Opioid Use
• Interventions: Other: Standard of care; Device: Nottingham AR smartphone app with active intervention

• Registration Number: NCT05634291
• Lead Sponsor: VRx Medical Inc

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.

Study Timeline

• Study Start: 2022-06-13
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-02
• Status Verified: 2023-02
• Primary Completion: 2023-06-16
• Study Completion: 2023-07-21
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of Care followed by AR digital treatment	Nottingham AR smartphone app with active intervention	Standard of care period without active intervention followed by Digital treatment with active intervention
Standard of Care followed by AR digital treatment	Standard of care	Standard of care period without active intervention followed by Digital treatment with active intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States