Virtual Reality Therapy for Chronic Low Back Pain

Not Applicable

Completed

Conditions: Chronic Low Back Pain

Interventions: Device: PICO G2 4k

Registration Number: NCT04409353

Lead Sponsor: Cedars-Sinai Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 413

Inclusion Criteria

Able to provide consent to participate in research
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, age 13 or older
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.
Ability to comprehend spoken and written English
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

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
Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital
Received surgical procedure within the previous 8 weeks
Surgery is planned within the next 3 months
Is currently using a spinal cord stimulator
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
Previously participated in a virtual reality clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Program B	PICO G2 4k	This arm will include software that provides immersive distraction based content for pain reduction.
Virtual Reality Program A	PICO G2 4k	This arm will include software that provides immersive skills-based content for pain reduction.
Virtual Reality Program C	PICO G2 4k	This arm will include software that provides nonimmersive distraction based content for pain reduction.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.