Virtual Reality Therapy for Chronic Low Back Pain

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).

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)

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).

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).

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).

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.

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.

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).

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.

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.

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.