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Completed

NCT Number: NCT04468074

Virtual Reality Treatment for Adults With Chronic Back Pain

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.

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Key information

Conditions

Chronic Pain Back Pain Back Pain Lower Back Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Boulder

Boulder, Colorado, 80301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual Reality Therapy for Chronic Pain

Device
  • 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

Other names: Virtual Reality Neuropsychological Therapy (VRNT)

Primary outcomes

  1. Change in Pain Intensity and Interference.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

Secondary outcomes

  1. Change in Quality of Life.

    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.

    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.

  2. Change in Back Pain Disability.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

    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

Other outcomes

  1. Change in Pain Bothersomeness.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  2. Change in Medications and Therapies.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

    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.

  3. Change in Pain Catastrophizing.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  4. Change in Fear of Pain.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  5. Change in Fear of Movement.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  6. Change in Sleep Quality.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

    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).

  7. Change in Fatigue Symptoms.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

    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).

  8. Change in Depression.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  9. Change in Pain Attitudes.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

    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].

  10. Change in Self-efficacy.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  11. Expectations of Treatment Success.

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

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

  12. Impression of Treatment Success.

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

    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.

  13. Change in Optimism

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  14. Change in Emotion Regulation.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  15. Change in Mindfulness.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  16. Change in Pain Coping Strategies.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  17. Change in Structural (Brain) MRI.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  18. Change in Resting-State Functional MRI.

    Time frame: from pre-treatment to post-treatment = 8 weeks.

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

  19. Change in Diffusion Tensor Imaging (DTI) MRI.

    Time frame: Change from pre-treatment to post-treatment = 8 weeks.

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

  20. Assessment of Usability of VR Device.

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

    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).

  21. Assessment of Sense of Presence in the VR Environment.

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

    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).

  22. Assessment of Sense of Embodiment in the VR Environment.

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

    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).

Sponsors and collaborators

Lead sponsor

CognifiSense Inc.

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2020
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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