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

Sponsor
VRx Medical Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05634291
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), San Diego Veterans Healthcare System (U.S. Fed)
36
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2
11.6
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard of care
  • Device: Nottingham AR smartphone app with active intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of the Nottingham Arthritis App for Arthritis Pain
Actual Study Start Date :
Jun 13, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard of Care

Standard of care period without active intervention

Other: Standard of care
Standard of care as prescribed by healthcare provider.

Active Comparator: AR digital treatment

Digital treatment with active intervention

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Milligrams of Morphine Equivalent (MME) [Change from baseline to day 30]

    MME is a standard measure of opioid use

Secondary Outcome Measures

  1. Non-opioid pain medicine usage [Change from baseline to day 30]

    Pain medicine usage will be tracked for dose and frequency.

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA San Diego Healthcare System San Diego California United States 92161

Sponsors and Collaborators

  • VRx Medical Inc
  • National Institute on Drug Abuse (NIDA)
  • San Diego Veterans Healthcare System

Investigators

  • Principal Investigator: Thomas Rutledge, PhD, San Diego Veterans Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VRx Medical Inc
ClinicalTrials.gov Identifier:
NCT05634291
Other Study ID Numbers:
  • H210106
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by VRx Medical Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022