Chronic Low-back Pain
Conditions
Brief summary
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.
Interventions
DEVICEEaseVRx headset
EaseVRx is a virtual reality therapy intended to treat chronic pain
DEVICEActive control VR sham program
VR, 2d visual wildlife scenes similar to some EaseVRx content
Sponsors
Geisinger Clinic
National Institute on Drug Abuse (NIDA)
AppliedVR Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain: Numerical Pain Rating Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Outcome Assessments Completed by Participant | 12 weeks | Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant |
| Patient Compliance | 8 weeks | 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. |
| Opioid Consumption | 12 weeks | Morphine Milligram Equivalents (MME) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EaseVRx Group 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.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain | 52 |
| Active Control Group VR Sham Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content | 55 |
| Total | 107 |
Baseline characteristics
| Characteristic | EaseVRx Group | Active Control Group VR Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 55 Participants | 107 Participants |
| Age, Continuous | 51.5 years STANDARD_DEVIATION 13.5 | 51.4 years STANDARD_DEVIATION 12.9 | 51.4 years STANDARD_DEVIATION 13.1 |
| Numerical Pain Rating Scale | 6.0 units on a scale from 0 to 10 STANDARD_DEVIATION 1.9 | 5.9 units on a scale from 0 to 10 STANDARD_DEVIATION 1.5 | 5.9 units on a scale from 0 to 10 STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 52 Participants | 102 Participants |
| Sex: Female, Male Female | 38 Participants | 40 Participants | 78 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 55 |
| other Total, other adverse events | 0 / 52 | 0 / 55 |
| serious Total, serious adverse events | 0 / 52 | 0 / 55 |
Outcome results
Primary
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EaseVRx Group | Pain: Numerical Pain Rating Scale | 0.6 units on a scale | Standard Deviation 1.67 |
| Active Control Group VR Sham | Pain: Numerical Pain Rating Scale | 1.3 units on a scale | Standard Deviation 1.49 |
Secondary
Number of Outcome Assessments Completed by Participant
Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EaseVRx Group | Number of Outcome Assessments Completed by Participant | 30 total number of assessments completed | Standard Error 14.3 |
| Active Control Group VR Sham | Number of Outcome Assessments Completed by Participant | 28 total number of assessments completed | Standard Error 15.7 |
Secondary
Opioid Consumption
Morphine Milligram Equivalents (MME)
Time frame: 12 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| EaseVRx Group | Opioid Consumption | 6.75 Morphine Milligram Equivalents(MME) | Standard Error 3.37 |
| Active Control Group VR Sham | Opioid Consumption | 5.67 Morphine Milligram Equivalents(MME) | Standard Error 2.56 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EaseVRx Group | Patient Compliance | 37 modules | Standard Deviation 18.4 |
| Active Control Group VR Sham | Patient Compliance | 40 modules | Standard Deviation 19.3 |