Virtual Reality Treatment for Adults With Chronic Back Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468074
• Other study ID #: 19-0526
• Secondary ID: 1R43NR017575-01A
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: June 14, 2021

Study information

• Verified date: May 2022
• Source: CognifiSense Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 14, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Chronic Pain

Intervention

Device:
• Virtual Reality Therapy for Chronic Pain
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

Locations

Country	Name	City	State
United States	University of Colorado, Boulder	Boulder	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
CognifiSense Inc.	National Institute of Nursing Research (NINR), University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pain Bothersomeness.	Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Medications and Therapies.	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.	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Pain Catastrophizing.	Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Fear of Pain.	Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Fear of Movement.	Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Sleep Quality.	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).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Fatigue Symptoms.	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).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Depression.	Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Pain Attitudes.	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].	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Self-efficacy.	General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true [worse outcome], 4 = exactly true.	Change from pre-treatment to post-treatment = 8 weeks.
Other	Expectations of Treatment Success.	Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome).	Before Therapy Period begins (pre-treatment; after 2-week baseline).
Other	Impression of Treatment Success.	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.	At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
Other	Change in Optimism	Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Emotion Regulation.	Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Mindfulness.	Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never.	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Pain Coping Strategies.	Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question).	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Structural (Brain) MRI.	Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment.	Change from pre-treatment to post-treatment = 8 weeks.
Other	Change in Resting-State Functional MRI.	Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment.	from pre-treatment to post-treatment = 8 weeks.
Other	Change in Diffusion Tensor Imaging (DTI) MRI.	Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment.	Change from pre-treatment to post-treatment = 8 weeks.
Other	Assessment of Usability of VR Device.	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).	At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
Other	Assessment of Sense of Presence in the VR Environment.	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).	At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
Other	Assessment of Sense of Embodiment in the VR Environment.	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).	At the end of the Therapy Period (post-treatment; approx. 10 weeks into study)
Primary	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.	Change from pre-treatment to post-treatment = 8 weeks.
Secondary	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.	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.
Secondary	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	Change from pre-treatment to post-treatment = 8 weeks.