Chronic PainNCT05634291
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
A study testing Nottingham AR smartphone app with active intervention in people with Chronic Pain and Arthritis Hand, run by VRx Medical Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Arthritis Hand, Opioid Use
- What is being tested?
- Nottingham AR smartphone app with active intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.
Who cannot join
- 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
- fMRI exclusion only: Any factors that would prevent participation in fMRI
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: Effects of the Nottingham Arthritis App for Arthritis Pain
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.
Read the 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
- Being tested
- Standard of care, Nottingham AR smartphone app with active intervention
- Keywords
- Augmented Reality, Smartphone application, Digital Therapeutic
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of care as prescribed by healthcare provider.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care followed by AR digital treatment | Experimental | Standard of care period without active intervention followed by Digital treatment with active intervention Receives: Other: Standard of care; Device: Nottingham AR smartphone app with active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to day 30
Milligrams of Morphine Equivalent (MME)
MME is a standard measure of opioid use
Measured: Change from baseline to day 30
Secondary outcomes (4)
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.
Measured: Change from baseline to day 30
Non-opioid pain medicine usage
Pain medicine usage will be tracked for dose and frequency.
Measured: Change from baseline to day 30
Pain Disability Index (PDI)
PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain.
Measured: Change from baseline to day 30
Patient Health Questionnaire (PHQ-9)
PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity
Measured: Change from baseline to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start13 Jun 2022
- Primary completion16 Jun 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VRx Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), San Diego Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Thomas Rutledge, PhD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634291
- Sponsor's protocol ID
- H210106
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Nottingham Arthritis App for Arthritis Pain
- ClinicalTrials.gov ID
- NCT05634291
- Acronym / sponsor ID
- H210106
- Conditions
- Chronic Pain, Arthritis Hand, Opioid Use
- Keywords
- Augmented Reality, Smartphone application, Digital Therapeutic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VRx Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), San Diego Veterans Healthcare System
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care followed by AR digital treatment | Experimental | Other: Standard of care, Device: Nottingham AR smartphone app with active interventionStandard of care period without active intervention followed by Digital treatment with active intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.
Key exclusion criteria (5 listed)
- 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
- fMRI exclusion only: Any factors that would prevent participation in fMRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard of care as prescribed by healthcare provider. | Other | Standard of Care followed by AR digital treatment |
| Nottingham AR smartphone app with active interventionAR 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. | Device | Standard of Care followed by AR digital treatment |
Primary outcome
The Pain, Enjoyment of Life and General Activity scale (PEG)
Time frame: 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)
Time frame: Change from baseline to day 30
MME is a standard measure of opioid use
4 secondary outcomes
Resting State brain imaging data
Time frame: Change from baseline to day 30
Non-opioid pain medicine usage
Time frame: Change from baseline to day 30
Pain Disability Index (PDI)
Time frame: Change from baseline to day 30
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Rutledge, PhD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nottingham AR smartphone app with active intervention in people with Chronic Pain and Arthritis Hand, run by VRx Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pain, Enjoyment of Life and General Activity scale (PEG) (time frame: Change from baseline to day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.