NCT05634291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

July 25, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

November 21, 2022

Last Update Submit

July 22, 2023

Conditions

Chronic PainArthritis HandOpioid Use

Keywords

Augmented RealitySmartphone applicationDigital Therapeutic

Outcome Measures

Primary Outcomes (2)

  • 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

  • Milligrams of Morphine Equivalent (MME)

    MME is a standard measure of opioid use

    Change from baseline to day 30

Secondary Outcomes (4)

  • Resting State brain imaging data

    Change from baseline to day 30

  • Non-opioid pain medicine usage

    Change from baseline to day 30

  • Pain Disability Index (PDI)

    Change from baseline to day 30

  • Patient Health Questionnaire (PHQ-9)

    Change from baseline to day 30

Study Arms (1)

Standard of Care followed by AR digital treatment

EXPERIMENTAL

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

Other: Standard of careDevice: Nottingham AR smartphone app with active intervention

Interventions

Standard of careOTHER

Standard of care as prescribed by healthcare provider.

Standard of Care followed by AR digital treatment
Nottingham AR smartphone app with active interventionDEVICE

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.

Standard of Care followed by AR digital treatment

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female adults ages 21-80
  • 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
  • \) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.

You may not qualify if:

  • Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
  • Current active alcohol or substance use disorder as evidenced from medical record
  • Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
  • Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Thomas Rutledge, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 2, 2022

Study Start

June 13, 2022

Primary Completion

June 16, 2023

Study Completion

July 21, 2023

Last Updated

July 25, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)