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

Chronic Pain Clinical Trial

Official title:

Effects of the Nottingham Arthritis App for Arthritis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05634291
• Other study ID #: H210106
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: February 2023
• Source: VRx Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 21, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Chronic Pain
• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
VRx Medical Inc	National Institute on Drug Abuse (NIDA), San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Milligrams of Morphine Equivalent (MME)	MME is a standard measure of opioid use	Change from baseline to day 30
Secondary	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
Secondary	Non-opioid pain medicine usage	Pain medicine usage will be tracked for dose and frequency.	Change from baseline to day 30
Secondary	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
Secondary	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