Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 3:08 AM
Study NCT ID:
NCT04236804
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VANISH for Chronic Low Back Pain
Sponsor:
Ajay Wasan, MD, Msc
Organization:
Study Overview
Official Title:
VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) for Chronic Low Back Pain (CLBP)
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANISH
Brief Summary:
The program, called TMC-CP01, will use a combination of virtual reality, biofeedback, and psychological exercises to manage pain associated with Chronic Low Back Pain. Chronic pain affects an estimated 100 million Americans, around one-third of the U.S. population. One of the most prevalent conditions under chronic pain is Chronic Low Back Pain (CLBP). About 27% of chronic pain patients experience CLBP. It is the leading cause of disability in the world and 31 million Americans suffer from CLBP. The most common analgesic tool for pain patients, especially for LBP patients, is opioids. However, opioid users are subject to drug tolerance and physical dependence, which decreases efficacy and increases risk of complication. Long-term users often require doses up to ten times their original dose to achieve equivalent analgesia and, after months of exposure, patients' risk of addiction increases.
This project aims to introduce a digital intervention to standard CLBP management with a virtual reality-enabled pain management system that will improve pain management and decrease daily dosages of opioids.
This project aims to introduce a digital intervention to standard CLBP management with a virtual reality-enabled pain management system that will improve pain management and decrease daily dosages of opioids.
Detailed Description:
TMC-CP01 is a treatment based on the VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) system and method, which combines existing technologies and therapies into Virtual Reality (VR) to help people learn to auto-regulate the way their body feels. TMC-CP01 is designed specifically for pain management and is tailored for low back pain. The treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain over time. By providing patients an accessible and effective alternative pain management tool, patients can avoid opioid use, dependency, and resulting complications due to opioids. Change in daily opioid dose, expressed in morphine equivalents, is the primary outcome. TMC-CP01 uses virtual reality as a platform to enable and optimize biofeedback training and psychological exercises.
Virtual Reality, alone is a proven method for pain management both through distraction and through active pain control mechanisms. Due to its stimulating nature, VR has the power to claim the majority of a user's attention and distract them from other stimuli such as pain. Because it is so visually engaging, VR is a powerful tool for visualization, which can be used to optimize and enhance visualization of biofeedback. VR can also affect users' emotions and perception by providing a sense of presence and psychological engagement. With recent developments in portable head mounted display (HMD) technology, VR has become accessible to people on a much broader and more affordable scale and it represents an ideal platform to develop a non-invasive pain management tool for chronic pain. Biofeedback is at the heart of TMC-CP01 and is the main mechanism by which patients learn to control their physiology. By allowing patients to visualize their physiological processes, patients gain a greater mind-body awareness and can learn to auto-regulate physiological functions that previously seemed out of their control.
Virtual Reality, alone is a proven method for pain management both through distraction and through active pain control mechanisms. Due to its stimulating nature, VR has the power to claim the majority of a user's attention and distract them from other stimuli such as pain. Because it is so visually engaging, VR is a powerful tool for visualization, which can be used to optimize and enhance visualization of biofeedback. VR can also affect users' emotions and perception by providing a sense of presence and psychological engagement. With recent developments in portable head mounted display (HMD) technology, VR has become accessible to people on a much broader and more affordable scale and it represents an ideal platform to develop a non-invasive pain management tool for chronic pain. Biofeedback is at the heart of TMC-CP01 and is the main mechanism by which patients learn to control their physiology. By allowing patients to visualize their physiological processes, patients gain a greater mind-body awareness and can learn to auto-regulate physiological functions that previously seemed out of their control.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44DA049630-01 | NIH | None | https://reporter.nih.gov/quic… | View |