Clinical trial NCT04236804: VANISH for Chronic Low Back Pain
Official title: VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) for Chronic Low Back Pain (CLBP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Virtual Autonomic Neuromodulation Induced Systemic Healing
TMC-CP01
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Females or males 18 years of age and older at screening
* Diagnosis of Chronic Lower Back Pain (CLBP) and a \>50mg MME daily opioid dosage
* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
* Signed informed consent form

Exclusion Criteria:

* Subjects who, in the opinion of the study site principal investigator, have a psychotic disorder, dementia, or other issue which may make accurate data reporting difficult
* Subjects who do not speak fluent English
* Patient refusal

Primary outcomes:
measure: Assessment of Opioid Use Via Subject Report
timeFrame: Week 0
Secondary outcomes:
measure: Assessment of Opioid Use Via Subject Report
timeFrame: Week 4
measure: Assessment of Opioid Use Via Subject Report
timeFrame: Week 8
measure: Flowly (TMC-CP01) Virtual Reality Intervention Feasibility Via Change From Baseline in Heart Rate Variability (HRV) at 8 Weeks
timeFrame: 8 Weeks
measure: Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks
timeFrame: weekly, up to 8 weeks
measure: Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks
timeFrame: Baseline and Week 8
measure: Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks
timeFrame: Assessed weekly, change from baseline and Week 8 reported
measure: Assessment of Feelings About Pain
timeFrame: Week 0
measure: Assessment of Feelings About Pain
timeFrame: Week 4
measure: Assessment of Feelings About Pain
timeFrame: Week 8
measure: Assessment of Salivary Cortisol Levels
timeFrame: Week 0
measure: Assessment of Salivary Cortisol Levels
timeFrame: Week 4
measure: Assessment of Salivary Cortisol Levels
timeFrame: Week 8
measure: Assessment of Opioid Use Via Urinalysis
timeFrame: Week 0
measure: Assessment of Opioid Use Via Urinalysis
timeFrame: Week 4
measure: Assessment of Opioid Use Via Urinalysis
timeFrame: Week 8
measure: Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
timeFrame: Week 0
measure: Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
timeFrame: Week 4
measure: Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
timeFrame: Week 8
measure: Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
timeFrame: Week 0
measure: Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
timeFrame: Week 4
measure: Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
timeFrame: Week 8
measure: Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0
timeFrame: Week 0
measure: Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4
timeFrame: Week 4
measure: Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8
timeFrame: Week 8
measure: Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0
timeFrame: Week 0
measure: Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4
timeFrame: Week 4
measure: Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8
timeFrame: Week 8
measure: Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
timeFrame: Week 0
measure: Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
timeFrame: Week 4
measure: Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
timeFrame: Week 8
measure: Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0
timeFrame: Week 0
measure: Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4
timeFrame: Week 4
measure: Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8
timeFrame: Week 8
measure: Change in Pain Level Before vs After Intervention Via Flowly App
timeFrame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
measure: Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App
timeFrame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
measure: Change in Depression Level From Baseline to 8 Weeks Via Flowly App
timeFrame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Pain Medicine At Centre Commons
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ajay Wasan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: