Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 2
- 主要终点
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, Providers, Primary Investigator, and Biostatistician were all blinded to allocations until the end of data collection.
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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 differences are the lack of an on-demand library and 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.
干预措施: Distraction-Based VR (Device)
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 differences are the lack of an on-demand library and 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.
干预措施: Activity Tracker (Device)
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 the EaseVRx+ linear prescribed sequence but does not contain an on-demand library; the functionality of the user interface used to access the experiences is otherwise the same as EaseVRx+. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit.
干预措施: Sham VR (Device)
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 the EaseVRx+ linear prescribed sequence but does not contain an on-demand library; the functionality of the user interface used to access the experiences is otherwise the same as EaseVRx+. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit.
干预措施: Activity Tracker (Device)
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.
干预措施: Skills-Based VR (Device)
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.
干预措施: Activity Tracker (Device)
结局指标
主要结局
Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30
时间窗: 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).
次要结局
- 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)
- 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)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90(From baseline to end of treatment at day 90)
- 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)
- Change From Baseline to Day 90 in Weekly Average Opioid Usage(From baseline to end of treatment at day 90)
研究者
Brennan Spiegel
Staff Physician III
Cedars-Sinai Medical Center