Chronic Low Back Pain
Conditions
Keywords
Virtual Reality, Chronic Low Back Pain, Analgesia
Brief summary
This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.
Detailed description
This is a randomized double-blind, placebo-controlled trial for individuals with chronic lower back pain. This study investigates the effect of at-home virtual reality (VR) pain reduction therapies on a set of outcome measures. The primary outcome is Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will enroll 360 analyzable participants into one of three VR therapy groups. Data collection will occur at home via personal computer or smartphone (iPhone/android), with baseline data collected one week before the intervention is mailed to the patient. Participants will have the VR headset for 90 days. Patients are also sent Fitbit smartwatches to track physical activity.
Interventions
DEVICEDistraction-Based VR
Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Distraction software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html
DEVICESham VR
Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Sham software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html
DEVICESkills-Based VR
Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx+ software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html
DEVICEActivity Tracker
Participants among all arms will be provided the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collects biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, Providers, Primary Investigator, and Biostatistician were all blinded to allocations until the end of data collection.
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide consent to participate in research 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, age 13 or older 4. An ongoing low back-pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months. 5. Ability to comprehend spoken and written English 6. Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email.
Exclusion criteria
1. Presents with a condition that interferes with virtual reality usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the virtual reality images or follow audio instructions 2. Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital 3. Received surgical procedure within the previous 8 weeks 4. Surgery is planned within the next 3 months 5. Is currently using a spinal cord stimulator 6. Has low back pain attributable to a recognizable, specific pathology, including spinal infection, cancer, fracture, or inflammatory spondylopathies, consistent with the NIH Task force on Research Standards for chronic low back pain 7. Previously participated in a virtual reality clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 | From baseline to day 30 | The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from not at all (1) to very much (5) with a raw score calculated by a sum of the 8 items ranging from 8 to 40. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate worse pain interference. The difference from baseline is reported as Day 30 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain interference). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | From baseline to day 60, from baseline to end of treatment at day 90 | One of the secondary outcomes for this study will be self-reported pain interference (PI) using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from not at all (1) to very much (5), with a raw score calculated by a sum of the 8 items ranging from 8 to 40. Results are linked to a T-Score to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate worse pain interference. The difference from baseline is reported as Day 60 - baseline and Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced PI) |
| Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90. | From baseline to end of treatment at day 90 | The outcome for this study will be self-reported pain catastrophizing using the Pain Catastrophizing Survey Short Form 6 (PCS SF-6). Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. PCS is a 6-item short form survey that measures rates of high catastrophizing as defined by a score of ≥7. Items are rated on a 5-point Likert scale from not at all (0) to all the time (4) with a raw score calculated by a sum of the 6 items ranging from 0 to 24. The scale is positively scored, where higher scores indicate greater levels of pain catastrophizing. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain catastrophizing). |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90 | From baseline to end of treatment at day 90 | The primary outcome for this study will be self-reported anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety version 4. This scale assesses self-reported perceptions of fear, anxious misery (worry, dread), hyperarousal, and somatic symptoms related to arousal. Items are rated Items are rated on a 5-point Likert scale from never (1) to always (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Anxiety is positively scored, where higher scores indicate worse anxiety. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced anxiety). |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90 | From baseline to end of treatment at day 90 | The secondary outcome for this study will be self-reported Sleep Disturbance using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance version 6a. This scale assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Items are rated on a 5-point Likert scale from not at all (1) and very much (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Sleep Disturbance is positively scored, where higher scores indicate worse sleep disturbance. The negative difference from baseline corresponds to improvement of symptoms (reduced sleep disturbance). |
| Change From Baseline to Day 90 in Weekly Average Opioid Usage | From baseline to end of treatment at day 90 | The secondary outcome for the this study is the change from study baseline to Day 90 in the frequency of self-reported daily opioid use. Participants were asked at baseline and Day 90 Are you currently taking an opioid pain medication on a daily basis? Yes, No, or Not sure The number of Yes responses and the total number of responses is reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90 | From baseline to end of treatment at day 90 | The exploratory outcome for this study will be self-reported depression using Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 scale. The 4-item PROMIS Depression scale measures self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Items are rated on a 5-point Likert scale from never (1) to always (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate more severe depression. The negative difference from baseline corresponds to improvement of symptoms (reduced depression symptoms). |
| Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps | From day 1 to end of treatment at day 90 | The change in average daily steps, as measured by FitBit, is an exploratory endpoint to measure the change in daily physical activity of study participants throughout the duration of study participation. For example, higher number of steps across individuals may indicate greater physical activity, and increasing number of steps throughout the study may indicate improving physical activity. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Daily steps were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of daily steps taken over the first week of study participation is used as the baseline measurement because Fitbit devices were provisioned to participants after baseline measurements were recorded (e.g. start of treatment). Similarly, an average of daily steps recorded over the final seven days of treatment (to day 90) were measured. |
| Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score | From day 1 to end of treatment at day 90 | The change in average sleep score, as measured by FitBit, is an exploratory endpoint to measure the change of sleep quality throughout the duration of study participation. A higher change in sleep score may indicate improvement in the quality of sleep. Fitbit calculates sleep score using an algorithm which takes into account heart rate, total time asleep, and stages of sleep. Sleep scores range from 0-100, with the following categories: Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60 The average score ranges from 72 to 83. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Sleep scores were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of sleep scores recorded over the first week of study participation is used as the baseline. Similarly, an average of sleep scores recorded over the final seven days of treatment (to day 90) was measured. |
| Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC) | Measured at end of treatment at day 90 | The overall effect of the treatment from study baseline to Day 90, measured by the Patients' Global Impression of Change (PGIC) is an exploratory endpoint to assess the efficacy of Skills-based and Distraction VR. This scale measures self-reported belief regarding efficacy of treatment. At Day 90, participants are asked Since the start of the study, my overall pain is... with responses on a 7-point Likert scale from Very much improved (1) to Very much worse (7). Based on the PGIC assessment, a dichotomous scale of Yes or No was derived. A favorable response of 1-4 on the PGIC indicates Yes, significant improvement occurred over the course of the study. An unfavorable response of 5-7 indicates No, significant improvement did not occur over the course of the study. Number of participants who scored between 1-4, therefore indicating a significant improvement in their pain levels over the course of the study (Number of participants with Yes), are reported below. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90 | From baseline to end of treatment at day 90 | The exploratory outcome for this study will be self-reported physical function using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b. The 6-item PROMIS Physical Function scale measures measures self-reported functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living. Items are rated on a 5-point Likert scale from Cannot do (1) to Not at all (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30.Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Physical Function is positively scored, where higher T-scores indicate better physical function. The difference from baseline is reported as Day 90 - baseline, with positive differences indicating better physical function. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Cedars-Sinai physician partners at outpatient pain clinic, spine center, rheumatology, community partners such as the ACPA and Saban Clinic, and/or pulled directly from the medical record database between September 2020 and October 2023. All enrollment activities were conducted remotely, by telephone and electronic survey. Recruitment spanned from 10/21/2020 to 10/17/2023. 385 total participants were recruited, producing a final analyzable sample N=360.
Pre-assignment details
Of 1,213 screened participants, 413 met inclusion criteria and signed an eConsent form. Of these, only 385 successfully completed the minimum required 4 of 7 screening week surveys and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Distraction-Based VR EaseVRx-Distraction has the same number of experiences, the same approximate duration of experiences, and the identical user interface as EaseVRx, with a linear prescribed sequence of experiences. The key difference is that instead of offering a variety of VR experiences including education, games, and breath biofeedback, EaseVRx Distraction only includes 360-degree videos - which are also present in EaseVRx. This is intended to remove the effect of education and skills-based training, while preserving the immersive experience of 360- degree VR.
Distraction-Based VR: Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Distraction software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use.
https://www.pico-interactive.com/us/G2\_4K.html
Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. | 127 |
| Sham VR EaseVRx-Sham software includes 2D nature footage accompanied by neutral music that is selected to be neither relaxing nor distracting, rather than 360-degree, 3D, interactive content specially selected for efficacy. The experience of using EaseVRx-Sham is similar to watching a large-screen TV, but it is not interactive or immersive. EaseVRx Sham has the same number and duration of experiences as EaseVRx, and the functionality of the user interface used to access the experiences is the same. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit.
Sham VR: Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Sham software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use.
https://www.pico-interactive.com/us/G2\_4K.html
Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. | 127 |
| Skills-Based VR EaseVRx+ incorporates the evidence-based principles of CBT, mindful meditation, and physiologic biofeedback therapy using embedded biometric sensors. It combines psychoeducation, pain education, breathing training, relaxation exercises, and executive functioning games to provide a mind-body approach toward living better with chronic pain. The standardized, prescriptive, and reproducible 56-day program delivers a combination of skills training and CBT-related treatments through scheduled daily virtual experiences. EaseVRx+ also features an on-demand library, allowing users to access any of the unique video sessions as needed.
Skills-Based VR: Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx+ software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use.
https://www.pico-interactive.com/us/G2\_4K.html
Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. | 131 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 |
| Overall Study | Discontinued intervention prior to end of follow-up | 4 | 11 | 6 |
| Overall Study | Disease burden - unable to participate | 0 | 1 | 1 |
| Overall Study | Intervention too complicated | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 4 | 1 | 3 |
| Overall Study | Life event occurred during participation window | 3 | 2 | 4 |
| Overall Study | Lost to Follow-up | 6 | 8 | 7 |
| Overall Study | Major surgery during participation window | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Sham VR | Total | Distraction-Based VR | Skills-Based VR |
|---|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 16.5 | 54.1 years STANDARD_DEVIATION 15.6 | 54.9 years STANDARD_DEVIATION 14.6 | 54.8 years STANDARD_DEVIATION 15.7 |
| Average low-back pain in past 7 days | 5.8 units on a scale STANDARD_DEVIATION 1.8 | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.9 units on a scale STANDARD_DEVIATION 2 |
| Average of daily back pain assessments | 6.0 units on a scale STANDARD_DEVIATION 1.9 | 6.1 units on a scale STANDARD_DEVIATION 1.9 | 6.0 units on a scale STANDARD_DEVIATION 1.9 | 6.3 units on a scale STANDARD_DEVIATION 1.9 |
| Back Pain Operation No | 84 Participants | 264 Participants | 92 Participants | 88 Participants |
| Back Pain Operation Yes, more than one | 14 Participants | 52 Participants | 15 Participants | 23 Participants |
| Back Pain Operation Yes, one | 29 Participants | 69 Participants | 20 Participants | 20 Participants |
| Back Pain Severity No | 21 Participants | 61 Participants | 20 Participants | 20 Participants |
| Back Pain Severity Not sure | 12 Participants | 42 Participants | 15 Participants | 15 Participants |
| Back Pain Severity Yes | 94 Participants | 282 Participants | 92 Participants | 96 Participants |
| Chronic Pain | 2.9 units on a scale STANDARD_DEVIATION 1.9 | 2.9 units on a scale STANDARD_DEVIATION 1.9 | 3.0 units on a scale STANDARD_DEVIATION 2 | 2.9 units on a scale STANDARD_DEVIATION 1.9 |
| Education Bachelor's Degree | 36 Participants | 104 Participants | 37 Participants | 31 Participants |
| Education Graduate or Professional School diploma | 37 Participants | 104 Participants | 32 Participants | 35 Participants |
| Education High School diploma or equivalent (GED) | 6 Participants | 21 Participants | 8 Participants | 7 Participants |
| Education Some College/Certificate | 28 Participants | 93 Participants | 30 Participants | 35 Participants |
| Education Some Graduate School or Professional School | 9 Participants | 28 Participants | 8 Participants | 11 Participants |
| Education Upper Secondary (High School) | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Education Vocational/Trade School | 9 Participants | 28 Participants | 10 Participants | 9 Participants |
| Employment Full-time employment | 53 Participants | 132 Participants | 41 Participants | 38 Participants |
| Employment Not employed | 20 Participants | 81 Participants | 25 Participants | 36 Participants |
| Employment Part-time employment | 17 Participants | 51 Participants | 18 Participants | 16 Participants |
| Employment Retired | 37 Participants | 121 Participants | 43 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 93 Participants | 32 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 281 Participants | 93 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 2 Participants | 5 Participants |
| Income $100,000-$149,999 | 21 Participants | 53 Participants | 14 Participants | 18 Participants |
| Income $10,000-$24,999 | 10 Participants | 47 Participants | 17 Participants | 20 Participants |
| Income $150,000-$199,999 | 8 Participants | 25 Participants | 9 Participants | 8 Participants |
| Income $200,000 or more | 16 Participants | 38 Participants | 12 Participants | 10 Participants |
| Income $25,000-$34,999 | 5 Participants | 21 Participants | 13 Participants | 3 Participants |
| Income $35,000-$49,999 | 9 Participants | 34 Participants | 11 Participants | 14 Participants |
| Income $50,000-$74,999 | 18 Participants | 49 Participants | 16 Participants | 15 Participants |
| Income $75,000-$99,999 | 16 Participants | 46 Participants | 16 Participants | 14 Participants |
| Income Less than $10,000 | 7 Participants | 22 Participants | 6 Participants | 9 Participants |
| Income Prefer not to answer | 17 Participants | 50 Participants | 13 Participants | 20 Participants |
| ITQ score | 102.2 units on a scale STANDARD_DEVIATION 17.7 | 100.6 units on a scale STANDARD_DEVIATION 17.7 | 99.9 units on a scale STANDARD_DEVIATION 18.1 | 99.6 units on a scale STANDARD_DEVIATION 17.7 |
| Marital Status Divorced | 19 Participants | 55 Participants | 19 Participants | 17 Participants |
| Marital Status Domestic Partner | 8 Participants | 24 Participants | 9 Participants | 7 Participants |
| Marital Status Married | 59 Participants | 162 Participants | 46 Participants | 57 Participants |
| Marital Status Never married | 34 Participants | 117 Participants | 40 Participants | 43 Participants |
| Marital Status Separated | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Marital Status Widowed | 6 Participants | 23 Participants | 11 Participants | 6 Participants |
| Opioid Use No | 90 Participants | 263 Participants | 84 Participants | 89 Participants |
| Opioid Use Not sure | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Opioid Use Yes | 36 Participants | 117 Participants | 41 Participants | 40 Participants |
| Patient Health Questionnaire-2 (PHQ-2) | 1.9 units on a scale STANDARD_DEVIATION 1.8 | 1.8 units on a scale STANDARD_DEVIATION 1.7 | 1.9 units on a scale STANDARD_DEVIATION 1.7 | 1.7 units on a scale STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 18 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 75 Participants | 25 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 11 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 25 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) White | 77 Participants | 251 Participants | 85 Participants | 89 Participants |
| Sex: Female, Male Female | 81 Participants | 241 Participants | 74 Participants | 86 Participants |
| Sex: Female, Male Male | 46 Participants | 144 Participants | 53 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 127 | 0 / 131 |
| other Total, other adverse events | 25 / 127 | 19 / 127 | 35 / 131 |
| serious Total, serious adverse events | 3 / 127 | 1 / 127 | 3 / 131 |
Outcome results
Primary
Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30
The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from not at all (1) to very much (5) with a raw score calculated by a sum of the 8 items ranging from 8 to 40. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate worse pain interference. The difference from baseline is reported as Day 30 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain interference).
Time frame: From baseline to day 30
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 | -1.15 units on a scale | Standard Deviation 6.63 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 | -1.86 units on a scale | Standard Deviation 5.06 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 | -1.67 units on a scale | Standard Deviation 5.93 |
Comparison: The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.488495% CI: [-0.87, 1.81]Mixed Models Analysis
Comparison: The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.809595% CI: [-1.12, 1.43]Mixed Models Analysis
Secondary
Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90.
The outcome for this study will be self-reported pain catastrophizing using the Pain Catastrophizing Survey Short Form 6 (PCS SF-6). Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. PCS is a 6-item short form survey that measures rates of high catastrophizing as defined by a score of ≥7. Items are rated on a 5-point Likert scale from not at all (0) to all the time (4) with a raw score calculated by a sum of the 6 items ranging from 0 to 24. The scale is positively scored, where higher scores indicate greater levels of pain catastrophizing. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain catastrophizing).
Time frame: From baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90. | -1.38 units on a scale | Standard Deviation 4.69 |
| Sham VR | Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90. | -3.04 units on a scale | Standard Deviation 4.59 |
| Skills-Based VR | Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90. | -3.27 units on a scale | Standard Deviation 4.84 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.p-value: 0.01895% CI: [0.25, 2.61]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.p-value: 0.574295% CI: [-1.48, 0.82]Mixed Models Analysis
Secondary
Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90
One of the secondary outcomes for this study will be self-reported pain interference (PI) using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from not at all (1) to very much (5), with a raw score calculated by a sum of the 8 items ranging from 8 to 40. Results are linked to a T-Score to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate worse pain interference. The difference from baseline is reported as Day 60 - baseline and Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced PI)
Time frame: From baseline to day 60, from baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 60 - baseline | -1.32 units on a scale | Standard Deviation 6.71 |
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 90 - baseline | -1.45 units on a scale | Standard Deviation 6.43 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 60 - baseline | -2.41 units on a scale | Standard Deviation 6.18 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 90 - baseline | -2.79 units on a scale | Standard Deviation 5.23 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 60 - baseline | -2.79 units on a scale | Standard Deviation 7.73 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90 | Day 90 - baseline | -3.51 units on a scale | Standard Deviation 7.15 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.310195% CI: [-0.74, 2.32]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.632895% CI: [-2.13, 1.3]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.12695% CI: [-0.33, 2.64]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.p-value: 0.51595% CI: [-2.05, 1.03]Mixed Models Analysis
Secondary
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90
The primary outcome for this study will be self-reported anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety version 4. This scale assesses self-reported perceptions of fear, anxious misery (worry, dread), hyperarousal, and somatic symptoms related to arousal. Items are rated Items are rated on a 5-point Likert scale from never (1) to always (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Anxiety is positively scored, where higher scores indicate worse anxiety. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced anxiety).
Time frame: From baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90 | -1.89 units on a scale | Standard Deviation 9.14 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90 | -2.88 units on a scale | Standard Deviation 9.03 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90 | -1.97 units on a scale | Standard Deviation 6.95 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.p-value: 0.733895% CI: [-1.85, 2.62]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.p-value: 0.527995% CI: [-1.34, 2.6]Mixed Models Analysis
Secondary
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90
The secondary outcome for this study will be self-reported Sleep Disturbance using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance version 6a. This scale assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Items are rated on a 5-point Likert scale from not at all (1) and very much (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Sleep Disturbance is positively scored, where higher scores indicate worse sleep disturbance. The negative difference from baseline corresponds to improvement of symptoms (reduced sleep disturbance).
Time frame: From baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90 | -2.08 units on a scale | Standard Deviation 7.27 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90 | -2.44 units on a scale | Standard Deviation 7.14 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90 | -2.76 units on a scale | Standard Deviation 7.36 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.p-value: 0.183395% CI: [-0.56, 2.94]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.p-value: 0.700695% CI: [-2.04, 1.37]Mixed Models Analysis
Secondary
Change From Baseline to Day 90 in Weekly Average Opioid Usage
The secondary outcome for the this study is the change from study baseline to Day 90 in the frequency of self-reported daily opioid use. Participants were asked at baseline and Day 90 Are you currently taking an opioid pain medication on a daily basis? Yes, No, or Not sure The number of Yes responses and the total number of responses is reported.
Time frame: From baseline to end of treatment at day 90
Population: Responses marked as Not sure or missing were excluded from the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Baseline | 41 Participants |
| Distraction-Based VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Day 90 | 26 Participants |
| Sham VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Baseline | 36 Participants |
| Sham VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Day 90 | 26 Participants |
| Skills-Based VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Baseline | 40 Participants |
| Skills-Based VR | Change From Baseline to Day 90 in Weekly Average Opioid Usage | Day 90 | 30 Participants |
Comparison: The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.p-value: 0.191395% CI: [0.5, 1.15]Cochran-Mantel-Haenszel
Comparison: The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.p-value: 0.36795% CI: [0.55, 1.24]Cochran-Mantel-Haenszel
Other Pre-specified
Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps
The change in average daily steps, as measured by FitBit, is an exploratory endpoint to measure the change in daily physical activity of study participants throughout the duration of study participation. For example, higher number of steps across individuals may indicate greater physical activity, and increasing number of steps throughout the study may indicate improving physical activity. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Daily steps were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of daily steps taken over the first week of study participation is used as the baseline measurement because Fitbit devices were provisioned to participants after baseline measurements were recorded (e.g. start of treatment). Similarly, an average of daily steps recorded over the final seven days of treatment (to day 90) were measured.
Time frame: From day 1 to end of treatment at day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps | 204.59 steps per day | Standard Deviation 2980.2 |
| Sham VR | Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps | -810.86 steps per day | Standard Deviation 3810.49 |
| Skills-Based VR | Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps | 156.66 steps per day | Standard Deviation 2370.43 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.p-value: 0.29195% CI: [-602.98, 1986.14]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.p-value: 0.484295% CI: [-741.79, 1553.15]Mixed Models Analysis
Other Pre-specified
Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score
The change in average sleep score, as measured by FitBit, is an exploratory endpoint to measure the change of sleep quality throughout the duration of study participation. A higher change in sleep score may indicate improvement in the quality of sleep. Fitbit calculates sleep score using an algorithm which takes into account heart rate, total time asleep, and stages of sleep. Sleep scores range from 0-100, with the following categories: Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60 The average score ranges from 72 to 83. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Sleep scores were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of sleep scores recorded over the first week of study participation is used as the baseline. Similarly, an average of sleep scores recorded over the final seven days of treatment (to day 90) was measured.
Time frame: From day 1 to end of treatment at day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score | 0.34 units on a scale | Standard Deviation 2.94 |
| Sham VR | Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score | -1.17 units on a scale | Standard Deviation 7.69 |
| Skills-Based VR | Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score | -0.61 units on a scale | Standard Deviation 3.4 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.p-value: 0.422895% CI: [-1.48, 3.49]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.p-value: 0.836395% CI: [-2.92, 2.37]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90
The exploratory outcome for this study will be self-reported depression using Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 scale. The 4-item PROMIS Depression scale measures self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Items are rated on a 5-point Likert scale from never (1) to always (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate more severe depression. The negative difference from baseline corresponds to improvement of symptoms (reduced depression symptoms).
Time frame: From baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90 | -2.02 units on a scale | Standard Deviation 7.23 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90 | -2.14 units on a scale | Standard Deviation 7.37 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90 | -1.60 units on a scale | Standard Deviation 7.68 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.p-value: 0.972795% CI: [-1.8, 1.86]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.p-value: 0.642795% CI: [-1.4, 2.26]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90
The exploratory outcome for this study will be self-reported physical function using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b. The 6-item PROMIS Physical Function scale measures measures self-reported functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living. Items are rated on a 5-point Likert scale from Cannot do (1) to Not at all (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30.Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-Physical Function is positively scored, where higher T-scores indicate better physical function. The difference from baseline is reported as Day 90 - baseline, with positive differences indicating better physical function.
Time frame: From baseline to end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distraction-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90 | 0.74 units on a scale | Standard Deviation 4.14 |
| Sham VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90 | 1.56 units on a scale | Standard Deviation 4.56 |
| Skills-Based VR | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90 | 1.65 units on a scale | Standard Deviation 5.16 |
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.p-value: 0.161995% CI: [-1.98, 0.33]Mixed Models Analysis
Comparison: The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.p-value: 0.956995% CI: [-1.31, 1.24]Mixed Models Analysis
Other Pre-specified
Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC)
The overall effect of the treatment from study baseline to Day 90, measured by the Patients' Global Impression of Change (PGIC) is an exploratory endpoint to assess the efficacy of Skills-based and Distraction VR. This scale measures self-reported belief regarding efficacy of treatment. At Day 90, participants are asked Since the start of the study, my overall pain is... with responses on a 7-point Likert scale from Very much improved (1) to Very much worse (7). Based on the PGIC assessment, a dichotomous scale of Yes or No was derived. A favorable response of 1-4 on the PGIC indicates Yes, significant improvement occurred over the course of the study. An unfavorable response of 5-7 indicates No, significant improvement did not occur over the course of the study. Number of participants who scored between 1-4, therefore indicating a significant improvement in their pain levels over the course of the study (Number of participants with Yes), are reported below.
Time frame: Measured at end of treatment at day 90
Population: All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Distraction-Based VR | Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC) | 53 Participants |
| Sham VR | Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC) | 59 Participants |
| Skills-Based VR | Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC) | 68 Participants |
Comparison: Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups.p-value: 0.51495% CI: [0.48, 1.44]Regression, Logistic
Comparison: Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups.p-value: 0.2895% CI: [0.78, 2.36]Regression, Logistic