Virtual Reality Treatment for Adults With Chronic Back Pain

NCT04468074 | Completed Results FDA Device

• 2 other identifiers: 19-05261R43NR017575-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Quality of Life.

  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.

• Change in Back Pain Disability.

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

Other Outcomes (22)

• Change in Pain Bothersomeness.

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

• Change in Medications and Therapies.

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

• Change in Pain Catastrophizing.

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

Study Arms (2)

Therapy Group

EXPERIMENTAL

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.

Device: Virtual Reality Therapy for Chronic Pain

Standard of Care (SOC) Group

NO INTERVENTION

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.

Interventions

Virtual Reality Therapy for Chronic Pain 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

Also known as: Virtual Reality Neuropsychological Therapy (VRNT)

Therapy Group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CognifiSense Inc.: lead
• University of Colorado, Boulder: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Colorado, Boulder

Boulder, Colorado, 80301, United States

Location

Related Publications (2)

• 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.

  PMID: 27002445 BACKGROUND

• 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.

  PMID: 38466872 DERIVED

MeSH Terms

Conditions

Chronic Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marta Ceko
• Organization: University of Colorado, Boulder

Marta.Ceko@colorado.edu

443-835-6587

Study Officials

• Marta Ceko, Ph.D.

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Lynn Webster, MD

  CognifiSense Inc.

  PRINCIPAL INVESTIGATOR

• Tassilo Baeuerle

  CognifiSense Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 13, 2020
• Study Start: June 9, 2020
• Primary Completion: April 13, 2021
• Study Completion: June 14, 2021
• Last Updated: June 23, 2022
• Results First Posted: June 23, 2022

Record last verified: 2022-05

Locations

US (1)