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Virtual Reality Therapy for Chronic Low Back Pain

Primary Purpose

Chronic Lower Back Pain

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PICO G2 4k

About this trial

This is an interventional treatment trial for Chronic Lower Back Pain focused on measuring Virtual Reality, Chronic Lower Back Pain, analgesia

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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).
Are being recommended for long-term hospitalization that would require more than three-week stay inside the hospital.
Received recent surgery within the previous 8 weeks.
Any planned surgeries in the next 3 months.
Are currently using a spinal cord stimulator.
Have lower back pain attributable to a recognizable, specific pathology, such as infection, tumor, fracture, or inflammatory spondylopathy.
Previously participated in a virtual reality clinical trial.

Sites / Locations

Samuel Eberlein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Virtual Reality Program A

Virtual Reality Program B

Virtual Reality Program C

Arm Description

This arm will include software that provides immersive skills-based content for pain reduction.

This arm will include software that provides immersive distraction based content for pain reduction.

This arm will include software that provides nonimmersive distraction based content for pain reduction.

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System Pain Interference

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

Patient-Reported Outcomes Measurement Information System Pain Interference 8

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.

Pain Catastrophizing Survey Short Form 6

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.

Patient-Reported Outcomes Measurement Information System Anxiety 4

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.

Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a

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.

Use of Opioids

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).

Full Information

NCT ID

NCT04409353

First Posted

May 14, 2020

Last Updated

October 9, 2023

Sponsor

Cedars-Sinai Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04409353

Brief Title

Virtual Reality Therapy for Chronic Low Back Pain

Official Title

Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 21, 2020 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lower Back Pain

Keywords

Virtual Reality, Chronic Lower Back Pain, analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality Program A

Arm Type

Experimental

Arm Description

This arm will include software that provides immersive skills-based content for pain reduction.

Arm Title

Virtual Reality Program B

Arm Type

Active Comparator

Arm Description

This arm will include software that provides immersive distraction based content for pain reduction.

Arm Title

Virtual Reality Program C

Arm Type

Sham Comparator

Arm Description

This arm will include software that provides nonimmersive distraction based content for pain reduction.

Intervention Type

Device

Intervention Name(s)

PICO G2 4k

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient-Reported Outcomes Measurement Information System Pain Interference

Description

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.

Secondary Outcome Measure Information:

Title

Patient-Reported Outcomes Measurement Information System Pain Interference 8

Description

Time Frame

biweekly from week 6 to week 12

Title

Pain Catastrophizing Survey Short Form 6

Description

Time Frame

biweekly until week 12

Title

Patient-Reported Outcomes Measurement Information System Anxiety 4

Description

Time Frame

biweekly until week 12

Title

Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a

Description

Time Frame

biweekly until week 12

Title

Use of Opioids

Description

Time Frame

The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.

Other Pre-specified Outcome Measures:

Title

Patient-Reported Outcomes Measurement Information System Physical Function 6b

Description

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.

Time Frame

biweekly basis until week 12

Title

Patient-Reported Outcomes Measurement Information System Depression 4

Description

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.

Time Frame

biweekly until week 12

Title

Biometric data from Fitbit Charge 4 - Physical Activity

Description

The total steps per day per day will be collected to assess physical activity.

Time Frame

Continuously from week 1 to week 12

Title

Biometric data from Fitbit Charge 4 - Sleep Quantity

Description

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.

Time Frame

Continuously from week 1 to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, above the age of 13. 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. English speaking. The participant has either a personal computer or a smartphone (android/iphone) to the web-based complete surveys. Exclusion Criteria: 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). Are being recommended for long-term hospitalization that would require more than three-week stay inside the hospital. Received recent surgery within the previous 8 weeks. Any planned surgeries in the next 3 months. Are currently using a spinal cord stimulator. Have lower back pain attributable to a recognizable, specific pathology, such as infection, tumor, fracture, or inflammatory spondylopathy. Previously participated in a virtual reality clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brennan Spiegel, MD

Organizational Affiliation

Cedars-Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samuel Eberlein

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

2020 to 2024

IPD Sharing Access Criteria

The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.

Citations:

PubMed Identifier

34130965

Citation

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.

Results Reference

derived

Links:

URL

https://virtualmedicine.org/research/current/vr4backpain

Description

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

Learn more about this trial

Virtual Reality Therapy for Chronic Low Back Pain

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