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Virtual Reality Treatment for Adults With Chronic Back Pain

Primary Purpose

Chronic Pain, Back Pain Lower Back Chronic, Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality Therapy for Chronic Pain

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants aged 21 to 70 with Chronic Back Pain.
Chronic Back Pain will be defined according to criteria established by recent NIH task force. Pain duration must be ≥ 3 months, with back pain being an ongoing problem for at least half the days of last 6 months; i.e., either pain every day for past 3 months, or half or more of the days for past 6+ months.
Subjects must rate pain intensity at ≥ 4/10 on Brief Pain Inventory (average pain over the last week).
Participants must also be comfortable and able to communicate via email, text message, or phone in English. Participants must also be comfortable using a video-conferencing service such as Zoom to complete the on-line sessions.

Exclusion Criteria:

Applicants, who are pregnant, planning pregnancy, or breastfeeding
Back pain associated with compensation / litigation within 1 year.
Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy).
Chronic pain other than chronic back pain.
Diagnoses of schizophrenia, multiple personality dissociative identity disorder.
History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability.
History of substance abuse.
Inability to undergo MRI (determined at screening; see XVI: Risks to Participants).
Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome.
History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures.
History of vertigo, dizziness, susceptibility to motion sickness
History of head injury within 6 months,
Unexplained, unintended weight loss of 'â• 20 lbs in past year.
Self-reported history of (digital) eye strain or computer vision syndrome.
Unable or unwilling to meet study attendance requirements.
MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).

Sites / Locations

University of Colorado, Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapy Group

Standard of Care (SOC) Group

Arm Description

Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. A training session on the use of the VR hardware and software. Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.

Outcomes

Primary Outcome Measures

Change in Pain Intensity and Interference.

Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

Secondary Outcome Measures

Change in Quality of Life.

Quality of Life (HRQoL SF-12) Questionnaire: yes / no questions and 3-point / 6-point Likert Scale questions; e.g., 1 = [negative impact] all of the time (worse outcome), 6 = [negative impact] none of the time. HRQoL results in two sub-scales / components (Physical and Mental). The mean of these was taken to result in a single value.

Change in Back Pain Disability.

Oswestry Low Back Pain Disability Questionnaire (OLBPD). 6-point Likert Scale questions on impact of pain on various life aspects; e.g., 1 = no negative impact, 6 = prevents normal activity (worse outcome). Participants completed questionnaire at the beginning and end of a 2-week baseline period and at the end of the 8 week therapy / control period. The starting values were the average of the two reported pain measures at the beginning and end of the baseline period

Full Information

NCT ID

NCT04468074

First Posted

June 30, 2020

Last Updated

May 27, 2022

Sponsor

CognifiSense Inc.

Collaborators

University of Colorado, Boulder, National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT04468074

Brief Title

Virtual Reality Treatment for Adults With Chronic Back Pain

Official Title

Study on the Use of Virtual Reality Neuropsychological Therapy Technology (VRNT) for Chronic Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

June 9, 2020 (Actual)

Primary Completion Date

April 13, 2021 (Actual)

Study Completion Date

June 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CognifiSense Inc.

Collaborators

University of Colorado, Boulder, National Institute of Nursing Research (NINR)

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Participants with chronic back pain will complete an online eligibility questionnaire. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period") during which they complete a daily pain survey. Following the Baseline Period all participants complete an MRI scan. After the MRI, scan participants are randomized into a treatment group ("Therapy Group") or a no-intervention group ("Standard of Care Group" or "SOC Group") with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive education about chronic pain. They also participate in sessions to personalize their Virtual Reality (VR) experience, and to complete training on the use of the VR hardware and software. Therapy Group participants complete the treatment for 8 weeks ("Therapy Period"), after which they return the VR equipment. All participants take a second MRI scan approximately 8-weeks after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After the Therapy Period, Therapy Group participants continue to complete daily pain surveys during a two-week follow-up period ("Follow-Up Period"). All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and before and after the Follow-Up Period. For Therapy Group participants the study ends with the final surveys and an exit interview at the end of the Follow-up Period. Study Extension (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those who elect to do so will complete the same set of surveys as the Therapy Group did during the treatment phase; however, since there is no comparison group, data from this study extension is not used in the main outcomes analyses.

6. Conditions and Keywords

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

Chronic Pain, Back Pain Lower Back Chronic, Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Therapy Group

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care (SOC) Group

Arm Type

No Intervention

Arm Description

The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.

Intervention Type

Device

Intervention Name(s)

Virtual Reality Therapy for Chronic Pain

Other Intervention Name(s)

Virtual Reality Neuropsychological Therapy (VRNT)

Intervention Description

A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises

Primary Outcome Measure Information:

Title

Change in Pain Intensity and Interference.

Description

Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Secondary Outcome Measure Information:

Title

Change in Quality of Life.

Description

Time Frame

Baseline (average of survey data at beginning and end of a 2-week baseline period) and at the end of the 8 week therapy / control period.

Title

Change in Back Pain Disability.

Description

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Other Pre-specified Outcome Measures:

Title

Change in Pain Bothersomeness.

Description

Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Medications and Therapies.

Description

A questionnaire asking participants to list the type and dosage / frequency of medication and therapies the participant is using for their back pain and for any other medical conditions. The list and dosage of medications and the type and frequencies of therapies will be compared pre- and post-treatment (8-week interval) to assess change in other pain therapies.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Pain Catastrophizing.

Description

Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Fear of Pain.

Description

Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Fear of Movement.

Description

Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Sleep Quality.

Description

Patient Reported Outcomes Measurement Information System (PROMIS) short form for Sleep Disturbance: 8 items. 5-point Likert scales: 5 = not at all, 1 = very much (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Fatigue Symptoms.

Description

Patient Reported Outcomes Measurement Information System (PROMIS) short form for Fatigue: 8 items. 5-point Likert scales: 1 = not at all, 5 = very much (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Depression.

Description

Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Pain Attitudes.

Description

Survey of Pain Attitudes (SOPA) Short Form. 6-point Likert scale: 5 = This is very untrue for me, 1 = This is very true for me [worse outcome].

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Self-efficacy.

Description

General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true [worse outcome], 4 = exactly true.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Expectations of Treatment Success.

Description

Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome).

Time Frame

Before Therapy Period begins (pre-treatment; after 2-week baseline).

Title

Impression of Treatment Success.

Description

Patient Global Impression of Change (PGIC). 7-point scale: 0 = no change (condition has got worse [worst outcome]), 10 = a great deal better, and a considerable improvement that has made all the difference.

Time Frame

At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).

Title

Change in Optimism

Description

Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Emotion Regulation.

Description

Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Mindfulness.

Description

Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Pain Coping Strategies.

Description

Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question).

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Structural (Brain) MRI.

Description

Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Change in Resting-State Functional MRI.

Description

Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment.

Time Frame

from pre-treatment to post-treatment = 8 weeks.

Title

Change in Diffusion Tensor Imaging (DTI) MRI.

Description

Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment.

Time Frame

Change from pre-treatment to post-treatment = 8 weeks.

Title

Assessment of Usability of VR Device.

Description

Questionnaire with 10 questions on usability of the VR device; 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree (worse outcome is a function of the question).

Time Frame

At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).

Title

Assessment of Sense of Presence in the VR Environment.

Description

Questionnaire with 14 questions about the participant's sense of presence in the virtual environment - based on IGP Presence Questionnaire; 5-point Likert scale: 1 = fully disagree, 5 = fully agree (worse outcome is a function of the question).

Time Frame

At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).

Title

Assessment of Sense of Embodiment in the VR Environment.

Description

Questionnaire with 10 questions about the participant's sense of embodiment in the virtual reality environment - based on the Gonzalez-Franko Embodiment Questionnaire; 7-point Likert scale from -3 = strongly disagree to +3 = strongly agree (worse outcome is a function of the question).

Time Frame

At the end of the Therapy Period (post-treatment; approx. 10 weeks into study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants aged 21 to 70 with Chronic Back Pain. Chronic Back Pain will be defined according to criteria established by recent NIH task force. Pain duration must be ≥ 3 months, with back pain being an ongoing problem for at least half the days of last 6 months; i.e., either pain every day for past 3 months, or half or more of the days for past 6+ months. Subjects must rate pain intensity at ≥ 4/10 on Brief Pain Inventory (average pain over the last week). Participants must also be comfortable and able to communicate via email, text message, or phone in English. Participants must also be comfortable using a video-conferencing service such as Zoom to complete the on-line sessions. Exclusion Criteria: Applicants, who are pregnant, planning pregnancy, or breastfeeding Back pain associated with compensation / litigation within 1 year. Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy). Chronic pain other than chronic back pain. Diagnoses of schizophrenia, multiple personality dissociative identity disorder. History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability. History of substance abuse. Inability to undergo MRI (determined at screening; see XVI: Risks to Participants). Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome. History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures. History of vertigo, dizziness, susceptibility to motion sickness History of head injury within 6 months, Unexplained, unintended weight loss of 'â• 20 lbs in past year. Self-reported history of (digital) eye strain or computer vision syndrome. Unable or unwilling to meet study attendance requirements. MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marta Ceko, Ph.D.

Organizational Affiliation

University of Colorado, Boulder

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lynn Webster, MD

Organizational Affiliation

CognifiSense Inc.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tassilo Baeuerle

Organizational Affiliation

CognifiSense Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado, Boulder

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27002445

Citation

Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

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Virtual Reality Treatment for Adults With Chronic Back Pain

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