Chronic Low-back PainNCT04139564

EaseVRx for the Reduction of Chronic Pain and Opioid Use

A study testing EaseVRx headset in people with Chronic Low-back Pain, run by AppliedVR Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: EaseVRx headset
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2021to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

≥ 18 years old
Low back pain experienced ≥ 3 days per week on average for ≥ 6 months
Pre-medication NPRS score ≥ 5 stable for ≥ 3 months

Who cannot join

Exclusions based on potential medical or lifestyle confounders:
Has a body mass index (BMI) > 40 kg/m2
Pain related to cancer, fibromyalgia, or disk herniation
History of a major psychiatric disorder not controlled with medication or has behavioral factors that would interfere with proper study procedures
Is not ambulatory/has significant motor impairment
Surgery in the past 3 months

Show all 23Show fewer

Open workers compensation claim
Planning to have surgery in the next 3 months
Planning to start a new exercise program in the next 3 months
Planning to start a new treatment for their pain (e.g. medication, physiotherapy, acupuncture, electrical nerve stimulation) in the next 3 months
Exclusions based on potential drug-related cofounders:
Current or recent history (in past year) of substance abuse disorder
Currently pregnant/breastfeeding or planning to in the next 3 months
Was administered an epidural steroid during the 3 months prior to screening
Exclusions based on ability to use EaseVR effectively:
Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception
Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness
Hypersensitivity to flashing lights or motion
Claustrophobia
Lack of stereoscopic vision
Severe hearing impairment
Injury to eyes, face, or neck that prevents comfortable VR usage
Planning to take a vacation from their home for more than one week in the next 8 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Medical Center
Danville, Pennsylvania, 17822

Other trials in United States

About this study

Official title: Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.

Read the detailed description

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.

Conditions: Chronic Low-back Pain
Being tested: EaseVRx headset, Active control VR sham program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EaseVRx headsetDevice
EaseVRx is a virtual reality therapy intended to treat chronic pain
Active control VR sham programDevice
VR, 2d visual wildlife scenes similar to some EaseVRx content

Study groups in NCT04139564
Study group	Role	What they receive
EaseVRx group	Experimental	Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. Receives: Device: EaseVRx headset
Active control group VR Sham	Active comparator	Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content Receives: Device: Active control VR sham program

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain: Numerical Pain Rating Scale
Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain
The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score
A positive difference implies that pain was reduced
Measured: 12 weeks

Secondary outcomes (3)

Number of Outcome Assessments Completed by Participant
Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant
Measured: 12 weeks
Patient Compliance
number of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best.
Measured: 8 weeks
Opioid Consumption
Morphine Milligram Equivalents (MME)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202131 Aug 2022

First posted25 Oct 2019
Study start11 Jan 2021
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Low-back 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04139564
Sponsor's protocol ID: 2019-1017
Other IDs: 5R44DA050231
Status last verified: Mar 2024
First submitted: 23 Oct 2019
Last updated: 27 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
ClinicalTrials.gov ID: NCT04139564
Acronym / sponsor ID: 2019-1017
Conditions: Chronic Low-back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: AppliedVR Inc.Industry (pharma, biotech, devices)
Collaborators: Geisinger Clinic, National Institute on Drug Abuse (NIDA)
Study start: 11 Jan 2021 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 25 Oct 2019 (actual)
Results: Posted 27 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.

Detailed description

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EaseVRx group	Experimental	Device: EaseVRx headsetEach subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
Active control group VR Sham	Active comparator	Device: Active control VR sham programEach subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

≥ 18 years old
Low back pain experienced ≥ 3 days per week on average for ≥ 6 months
Pre-medication NPRS score ≥ 5 stable for ≥ 3 months

Key exclusion criteria (23 listed)

Exclusions based on potential medical or lifestyle confounders:
Exclusions based on potential drug-related cofounders:
Exclusions based on ability to use EaseVR effectively:

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
EaseVRx headsetEaseVRx is a virtual reality therapy intended to treat chronic pain	Device	EaseVRx group
Active control VR sham programVR, 2d visual wildlife scenes similar to some EaseVRx content	Device	Active control group VR Sham

Primary outcome

Pain: Numerical Pain Rating Scale
Time frame: 12 weeks
Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced

3 secondary outcomes

Number of Outcome Assessments Completed by Participant
Time frame: 12 weeks
Patient Compliance
Time frame: 8 weeks
Opioid Consumption
Time frame: 12 weeks

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EaseVRx Group	52	52
Active Control Group VR Sham	55	55

Primary outcome: Pain: Numerical Pain Rating Scale

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	EaseVRx Group n = 52	Active Control Group VR Sham n = 55
Value	0.6 (1.67)	1.3 (1.49)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EaseVRx Group	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Active Control Group VR Sham	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

Chulhyun Ahn, MD principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EaseVRx headset in people with Chronic Low-back Pain, run by AppliedVR 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 23 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 27 Mar 2024. 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?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain: Numerical Pain Rating Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139564.

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 27 Mar 2024.