Chronic Low-back Pain, Anxiety, Depression
Conditions
Brief summary
The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.
Detailed description
This is a decentralized, randomized controlled trial with four parallel study arms comparing change from pre-treatment to end-of-treatment to 12-months posttreatment in the EaseVRx-8w, EaseVRx-8w plus extended on-demand and Control groups. After consenting to join the study, participants will be randomized and allocated to one of four treatment programs. Study devices will be delivered to the participant's home with instructions for use via FedEx with complementary remote technical support. * participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months after completion of treatment * participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment.• participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment * participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment All trial participants will be monitored for pain intensity and pain interference, physical function, behavioral skills development, health outcomes and satisfaction. Additionally, to assess resource use associated with CLBP, participant data will be run through a secure Datavant matching process to be linked to their healthcare claims data if it is available in the Komodo data set. The claims will provide descriptive characterizations of resource use and healthcare costs associated with CLBP. For participant-level changes in resource use, and for comparisons between study arms, only the participants with complete claims files will be assessed. Claims matched data will capture all interactions with the healthcare system that generate an insurance claim record, which includes such things as physician visits, interventions such as steroid injections, surgery or physical therapy, emergent use of services, medications, and diagnostic procedures. Claims adjudication often lags a few months, so the most robust analyses of utilization will be performed about 6 months after the time point of interest. Health economic modeling will be performed after 1 year to assess the cost and economic outcomes of the EaseVRx intervention.
Interventions
Sponsors
AppliedVR Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, study statisticians and investigators will be blinded to treatment group assignment until after the last subject contributes their primary outcome at week 16. Prior to the primary analysis, the database will be officially locked and signed off by the Sponsor and key stakeholders. Study participants will remain blinded to treatment group assignment until study completion.
Intervention model description
Enrolled participants will be randomized 1:1:1:1 and assigned to one of four treatment arms: * 56-day skills-based VR program (EaseVRx-8w) * 56-day skills-based VR program followed by an extended 56-day on-demand period (EaseVRx-8w plus extended on-demand) * 56-day control (Sham VR) * 56-day control followed by an extended 56-day on-demand period (Sham VR plus 8w extended on-demand)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adults aged 18-85. * Self-reported chronic low back pain that will be confirmed with claims data when available. * Pain duration of at least three months. * Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening. * Fluency in English. * Willing and able to comply with all study procedures including all required restrictions for the duration of study participation. * Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study. * Access to Internet for the duration of their study participation (24 months). * Access to a smartphone or computer for the duration of the study. * Availability of a physical mailing address that is not a PO box address for receipt of the device. * Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period. * Able to provide photo ID
Exclusion criteria
* Unable to understand the goals of the study due to cognitive difficulty. * Any medical condition that may prevent the use of virtual reality (e.g., current, or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing participant to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment). * Injury to eyes, face, or neck that prevents comfortable use of VR. * Index back pain is linked to a cancer-related diagnosis. * Possible suicidal ideation as indicated by the 9th item of the Participant Health Questionnaire-9 (PHQ-9). * Previous participation in the 2020 AVR EaseVRx pivotal study. * Receiving worker's compensation and/or involved in any active litigation related to an injury. * Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months. * Participation of two or more members in one household * Recent or future medical procedures scheduled related to any current diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) Pain Intensity Questionnaire | Day 56 (end of treatment) | The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index Score (ODI v2.1b) | The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027 | The ODI questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 10 items that are summed with a score ranging from 0 - 100%. The higher the score the greater the impact of chronic pain on the participant. |
| PROMIS Sleep Disturbance | The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment | The PROMIS Sleep disturbance questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse sleep. |
| PROMIS Depression | The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment | The PROMIS Depression questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse depression. |
| PROMIS Anxiety | The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment | The PROMIS Anxiety questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 7 items that are summed with a raw score range from 0 - 35. The higher the score the worse anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 56-day Skills-based VR Program participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx
EaseVRx: VR software with interactive content | 269 |
| 56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment
EaseVRx: VR software with interactive content | 267 |
| 56-day Control (Sham VR) participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training
Sham VR: VR with neutral non-interactive content | 266 |
| • 56-day Control (Sham VR Plus 8w Extended On-demand) participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.
Sham VR: VR with neutral non-interactive content | 265 |
| Total | 1,067 |
Baseline characteristics
| Characteristic | 56-day Skills-based VR Program | Total | • 56-day Control (Sham VR Plus 8w Extended On-demand) | 56-day Control (Sham VR) | 56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period |
|---|---|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 13.4 | 51 years STANDARD_DEVIATION 13.2 | 51 years STANDARD_DEVIATION 12.7 | 52 years STANDARD_DEVIATION 12.9 | 50 years STANDARD_DEVIATION 13.5 |
| Brief Pain Inventory - Pain intensity | 6.56 units on a scale STANDARD_DEVIATION 1.48 | 6.68 units on a scale STANDARD_DEVIATION 1.48 | 6.77 units on a scale STANDARD_DEVIATION 1.54 | 6.67 units on a scale STANDARD_DEVIATION 1.44 | 6.71 units on a scale STANDARD_DEVIATION 1.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 9 Participants | 2 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 22 Participants | 3 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 178 Participants | 51 Participants | 42 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 25 Participants | 111 Participants | 31 Participants | 26 Participants | 29 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 12 Participants | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 188 Participants | 729 Participants | 175 Participants | 180 Participants | 186 Participants |
| Sex: Female, Male Female | 210 Participants | 777 Participants | 178 Participants | 188 Participants | 201 Participants |
| Sex: Female, Male Male | 59 Participants | 290 Participants | 87 Participants | 78 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 269 | 0 / 267 | 0 / 266 | 0 / 265 |
| other Total, other adverse events | 0 / 269 | 0 / 267 | 0 / 266 | 0 / 265 |
| serious Total, serious adverse events | 0 / 269 | 0 / 267 | 0 / 266 | 0 / 265 |
Outcome results
Primary
Brief Pain Inventory (BPI) Pain Intensity Questionnaire
The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
Time frame: Day 56 (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 56-day Skills-based VR Program | Brief Pain Inventory (BPI) Pain Intensity Questionnaire | 4.51 units on a scale | Standard Deviation 2.22 |
| 56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period | Brief Pain Inventory (BPI) Pain Intensity Questionnaire | 4.83 units on a scale | Standard Deviation 2.11 |
| 56-day Control (Sham VR) | Brief Pain Inventory (BPI) Pain Intensity Questionnaire | 5.25 units on a scale | Standard Deviation 2.15 |
| • 56-day Control (Sham VR Plus 8w Extended On-demand) | Brief Pain Inventory (BPI) Pain Intensity Questionnaire | 5.17 units on a scale | Standard Deviation 2.35 |
Secondary
Oswestry Disability Index Score (ODI v2.1b)
The ODI questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 10 items that are summed with a score ranging from 0 - 100%. The higher the score the greater the impact of chronic pain on the participant.
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027
Secondary
PROMIS Anxiety
The PROMIS Anxiety questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 7 items that are summed with a raw score range from 0 - 35. The higher the score the worse anxiety.
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
Secondary
PROMIS Depression
The PROMIS Depression questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse depression.
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
Secondary
PROMIS Sleep Disturbance
The PROMIS Sleep disturbance questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse sleep.
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment