Virtual Reality Therapy for Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT04409353
• Recruitment Status: Recruiting
• First Posted: June 1, 2020
• Last Update Posted: July 21, 2022
• Sponsor: Cedars-Sinai Medical Center
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Brennan Spiegel, Cedars-Sinai Medical Center

Study Description

Brief Summary:

This study will test the effectiveness of an evidence-based virtual reality therapy program as a non-pharmacological supplement to managing patients with pain due to chronic lower back pain. Outpatients will be randomized to receive one of three virtual reality (VR) programs: skills-based VR, distraction VR, or sham VR. All patients will receive a VR headset and Fitbit Charge 4 watch. Study devices will be delivered to the patient's home with instructions for use via FedEx; patients will receive remote technical support. Patients will be followed for 90 days and monitored for functional status, pain levels, use of pain medications (including opioids). Participants will also be asked to consent/authorization to access medical records from their treating facility.

Condition or disease	Intervention/treatment	Phase
Chronic Lower Back Pain	Device: PICO G2 4k	Not Applicable

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 therapy 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 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. The patient will have the VR headset for 90 days. A post-study survey will be sent to patients 30 days after the end of the study.

To learn more about the study and to assess your eligibility, please visit our study website at https://virtualmedicine.org/research/current/vr4backpain

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
• Actual Study Start Date: September 21, 2020
• Estimated Primary Completion Date: December 30, 2023
• Estimated Study Completion Date: December 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Virtual Reality Program A; This arm will include software that provides immersive skills-based content for pain reduction.	Device: PICO G2 4k; Participants will use the Pico G2 4K VR audio and visual head-mounted device. 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.
Active Comparator: Virtual Reality Program B; This arm will include software that provides immersive distraction based content for pain reduction.	Device: PICO G2 4k; Participants will use the Pico G2 4K VR audio and visual head-mounted device. 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.
Sham Comparator: Virtual Reality Program C; This arm will include software that provides nonimmersive distraction based content for pain reduction.	Device: PICO G2 4k; Participants will use the Pico G2 4K VR audio and visual head-mounted device. 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.

Outcome Measures

Primary Outcome Measures :

1. Patient-Reported Outcomes Measurement Information System Pain Interference [ Time Frame: This will be measured weekly for the first 4 weeks. The primary efficacy endpoint is the change from study baseline (Screening week, aka week -1) to week 4 in pain interference as measured by PROMIS-PI. ]
   The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8. 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. It is the 8 question version. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.

Secondary Outcome Measures :

1. Patient-Reported Outcomes Measurement Information System Pain Interference 8 [ Time Frame: biweekly from week 6 to week 12 ]
   PROMIS Pain Interference 8 will also be assessed after the first month of the study at a biweekly interval. As stated above the pain interference scale measures the consequences of pain on relevant aspects of one's life. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.
2. Pain Catastrophizing Survey Short Form 6 [ Time Frame: biweekly until week 12 ]
   Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. It will be measured using the Pain Catastrophizing scale (PCS) short form, which a 6-item questionnaire. The max score is 24 and the minimum is 0. The higher the score the worse the outcome.
3. Patient-Reported Outcomes Measurement Information System Anxiety 4 [ Time Frame: biweekly until week 12 ]
   Anxiety is a commonly comorbid disease with chronic lower back pain. The PROMIS Anxiety scale will be used to assess it. This is the 4 question version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
4. Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a [ Time Frame: biweekly until week 12 ]
   Given the impact of chronic pain on mental health there is also an impact on sleep. PROMIS Sleep Disturbance is a well-validated survey to assess sleep quality. This is version A of the 6 item scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
5. Use of Opioids [ Time Frame: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study. ]
   In order to capture use of opioids, we will link patient electronic health record (EHR) data to the other data sources using Medical Record Numbers and date of birth. We will also request access to the CURES database for research purposes. We will convert all opioid doses into a single metric using morphine milligram equivalents (MME).

Other Outcome Measures:

1. Patient-Reported Outcomes Measurement Information System Physical Function 6b [ Time Frame: biweekly basis until week 12 ]
   For patients with chronic pain, physical function is often diminished and patients seek return to normal function. The Patient-Reported Outcomes Measurement Information System Physical Function short-form 6b scale is a widely- validated instrument with excellent content validity, construct validity, and reliability in patients with spinal disorders and other conditions marked by diminished mobility. The instrument places patients on a continuum of function from extremely low to very high across activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
2. Patient-Reported Outcomes Measurement Information System Depression 4 [ Time Frame: biweekly until week 12 ]
   Depression is a commonly comorbid disease with chronic lower back pain. The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale will be used to assess it. This is the 4 item version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
3. Biometric data from Fitbit Charge 4 - Physical Activity [ Time Frame: Continuously from week 1 to week 12 ]
   The total steps per day per day will be collected to assess physical activity.
4. Biometric data from Fitbit Charge 4 - Sleep Quantity [ Time Frame: Continuously from week 1 to week 12 ]
   The total hours of sleep per night as well as sleep efficiency will be assessed for the quantity of sleep using the Fitbit charge 4. Data will be analyzed using the Fitabase system.

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, above the age of 13.
4. A 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. English speaking.
6. The participant has either a personal computer or a smartphone (android/iphone) to the web-based complete surveys.

Exclusion Criteria:

1. Are presenting with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).
2. Are being recommended for long-term hospitalization that would require more than three-week stay inside the hospital.
3. Received recent surgery within the previous 8 weeks.
4. Any planned surgeries in the next 3 months.
5. Are currently using a spinal cord stimulator.
6. Have lower back pain attributable to a recognizable, specific pathology, such as infection, tumor, fracture, or inflammatory spondylopathy.
7. Previously participated in a virtual reality clinical trial.

Contacts and Locations

Contacts

Contact: Samuel Eberlein, MS; 310-423-6721; samuel.eberlein@cshs.org

Contact: Joshua Fouladian; 310-423-6740; joshua.fouladian@cshs.org

Locations

United States, California

Samuel Eberlein; Recruiting

Los Angeles, California, United States, 90048

Contact: Samuel Eberlein vrstudymail@cshs.org

Sponsors and Collaborators

Cedars-Sinai Medical Center

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: Brennan Spiegel, MD; Cedars-Sinai

More Information

Additional Information:

Study web portal for more information and a self-assessment for eligibility 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Birckhead B, Eberlein S, Alvarez G, Gale R, Dupuy T, Makaroff K, Fuller G, Liu X, Yu KS, Black JT, Ishimori M, Venuturupalli S, Tu J, Norris T, Tighiouart M, Ross L, McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 15;11(6):e050545. doi: 10.1136/bmjopen-2021-050545.

• Responsible Party: Brennan Spiegel, Staff Physician III, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT04409353
• Other Study ID Numbers: Pro00000631; 1UG3AR076573-01 ( U.S. NIH Grant/Contract )
• First Posted: June 1, 2020
• Last Update Posted: July 21, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: This study is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative focused on understanding and developing new treatments for addiction and pain. Research gives us the best information and progresses more quickly when data is available from many studies and many individuals, and when many researchers can work with the data and samples and analyze them in different ways. Therefore, your data and samples will be used for this and other NIH Helping to End Addiction Long-term Initiative studies. Your stored data and samples will also be made widely available to other researchers. The shared data and samples may be used indefinitely for research not related to this study or the Helping to End Addiction Long-term (HELP) Initiative, without asking you for additional consent.
• Time Frame: 2020 to 2024
• Access Criteria: The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Brennan Spiegel, Cedars-Sinai Medical Center:

Virtual Reality; Chronic Lower Back Pain; analgesia

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations