Virtual Reality Treatment for Adults With Chronic Back Pain

NCT ID: NCT04468074

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2021-06-14

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.

Conditions

Chronic Pain; Back Pain Lower Back Chronic; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapy Group

Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:

1. An education session on the science behind chronic pain and a basic overview of the VR therapy.

2. A session to customize the VR experience to match the participant's own pain experience.

3. 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.

Group Type: EXPERIMENTAL

Virtual Reality Therapy for Chronic Pain

Intervention Type: DEVICE

1. A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy

2. Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises

Standard of Care (SOC) Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Therapy for Chronic Pain

1. A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy

2. Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises

Intervention Type: DEVICE

Other Intervention Names

Virtual Reality Neuropsychological Therapy (VRNT)

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

CognifiSense Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Ceko, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Lynn Webster, MD

Role: PRINCIPAL_INVESTIGATOR

CognifiSense Inc.

Tassilo Baeuerle

Role: PRINCIPAL_INVESTIGATOR

CognifiSense Inc.

Locations

University of Colorado, Boulder

Boulder, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27002445 (View on PubMed)

Ceko M, Baeuerle T, Webster L, Wager TD, Lumley MA. The effects of virtual reality neuroscience-based therapy on clinical and neuroimaging outcomes in patients with chronic back pain: a randomized clinical trial. Pain. 2024 Aug 1;165(8):1860-1874. doi: 10.1097/j.pain.0000000000003198. Epub 2024 Mar 8.

Reference Type: DERIVED

PMID: 38466872 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R43NR017575-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0526

Identifier Type: -

Identifier Source: org_study_id