Implementing TMC-CP01 Treatment Based on the Virtual Autonomic Neuromodulation Induced Systemic Healing System in Reducing Pain and Opioid Requirement in Subjects Suffering From Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study Assessing the Feasibility of Implementing TMC-CP01 Treatment Based on the VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) System in Reducing Pain and Opioid Requirement in Subjects Suffering From Chronic Low Back Pain (CLBP)

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Device: Flowly (TMC-CP01)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMC-CP01 Intervention<br>Ten patients will be randomly assigned to receive the TMC-CP01 intervention every day for 8 weeks in addition to their current opioid prescription and tapering guidelines. | Device: Flowly (TMC-CP01)<br>* TMC-CP01 is a device 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 guidelines.<br>* Other names: Virtual Reality;|
| No Intervention: Standard of Care<br>Ten patients will be randomly assigned to receive their current opioid prescription and tapering guidelines, as standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Opioid use via subject report | Daily dose of oral opioids recorded as morphine equivalents will be collected | Week 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Opioid Cravings using the Craving Index | The Craving Index questionnaire on the Flowly app will assess opioid cravings with 6 qualitatively scaled questions from none to the greatest possibility. Reports on the qualitative scale that are indicate infrequency (left on scale) suggest better outcomes. Measurements will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Physical Function using PROMIS | The investigators will use 4 physical function questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Fatigue using PROMIS | The investigators will use 4 fatigue questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Pain Interference using PROMIS | The investigators will use 5 pain questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Pain Intensity using PROMIS | The investigators will use a pain question to assess key patient centered outcomes that the intervention may improve. This question are from the PROMIS. These questions are ranked on a 11-point (0-11) Likert Scale. The minimum score is 0 and the maximum score is 10. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Sleep Disturbance using PROMIS | The investigators will use 4 sleep disturbance questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Ability to Participate in Social Roles and Activities using PROMIS | The investigators will use 4 Ability to Participate in Social Roles and Activities questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Depression using PROMIS | The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Anxiety using PROMIS | The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of Loneliness using PROMIS | The investigators will use 4 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the PROMIS. These questions are ranked on a 5-point (1-5) Likert Scale. The minimum score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | weekly, up to 8 weeks | 
| Assessment of feelings about pain | The PainDetect Questionnaire will assess subject feelings about pain with 15 multiple choice questions and a drawing of localized pain. The with a minimum score is 0 and maximum score is 38. Lower scores suggest better outcomes and less neuropathic pain. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of feelings about pain | The PainDetect Questionnaire will assess subject feelings about pain with 15 multiple choice questions and a drawing of localized pain. The with a minimum score is 0 and maximum score is 38. Lower scores suggest better outcomes and less neuropathic pain. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of feelings about pain | The PainDetect Questionnaire will assess subject feelings about pain with 15 multiple choice questions and a drawing of localized pain. The with a minimum score is 0 and maximum score is 38. Lower scores suggest better outcomes and less neuropathic pain. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Flowly (TMC-CP01) virtual reality intervention feasibility via Change From Baseline in Heart Rate Variability (HRV) at 8 Weeks | HRV will be modulated by conforming respiration and heart rate to optimal breathing patterns. The games are designed to guide subjects' physiology to a more optimal state for pain reduction using biofeedback. Resonant breathing is breathing that activates the coordinated function of oscillating body systems. This breathing increases your Heart Rate Variability. Greater Heart Rate Variability (a higher HRV score) at rest indicates better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | 8 Weeks | 
| Assessment of Opioid use via subject report | The amount and dosing of opioid medications taken by each subject will be recorded throughout the study. The lower the average daily morphine milligram equivalent [MME], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Opioid use via subject report | The amount and dosing of opioid medications taken by each subject will be recorded throughout the study. The lower the average daily morphine milligram equivalent [MME], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Salivary cortisol levels | Subjects' salivary cortisol measurements will be measured over the span of the study and compared between the two groups. The lower the cortisol level mcg/dL detected, the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Salivary cortisol levels | Subjects' salivary cortisol measurements will be measured over the span of the study and compared between the two groups. The lower the cortisol level mcg/dL detected, the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Salivary cortisol levels | Subjects' salivary cortisol measurements will be measured over the span of the study and compared between the two groups. The lower the cortisol level mcg/dL detected, the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Opioid use via urinalysis | The amount of opiates found in the urine of each subject will be recorded throughout the study. The lower the detected morphine milligram equivalent [MME], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Opioid use via urinalysis | The amount of opiates found in the urine of each subject will be recorded throughout the study. The lower the detected morphine milligram equivalent [MME], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Opioid use via urinalysis | The amount of opiates found in the urine of each subject will be recorded throughout the study. The lower the detected morphine milligram equivalent [MME], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Withdrawal symptoms using Opiate Withdrawal Scale | The opiate withdrawal scale will assess subject withdrawal symptoms with 16 multiple choice questions scaled from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Withdrawal symptoms using Opiate Withdrawal Scale | The opiate withdrawal scale will assess subject withdrawal symptoms with 16 multiple choice questions scaled from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Withdrawal symptoms using Opiate Withdrawal Scale | The opiate withdrawal scale will assess subject withdrawal symptoms with 16 multiple choice questions scaled from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Beliefs about pain using Pain Catastrophizing Scale | The Pain Catastrophizing Scale will assess subject beliefs about pain with 13 multiple choice questions scaled from 1-5 with a minimum score of 13 and with a maximum score of 65. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Beliefs about pain using Pain Catastrophizing Scale | The Pain Catastrophizing Scale will assess subject beliefs about pain with 13 multiple choice questions scaled from 1-5 with a minimum score of 13 and with a maximum score of 65. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Beliefs about pain using Pain Catastrophizing Scale | The Pain Catastrophizing Scale will assess subject beliefs about pain with 13 multiple choice questions scaled from 1-5 with a minimum score of 13 and with a maximum score of 65. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Feelings about treatment using Treatment Expectancy short form | Treatment Expectancy short form will assess feelings about treatment with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Feelings about treatment using Treatment Expectancy short form | Treatment Expectancy short form will assess feelings about treatment with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Feelings about treatment using Treatment Expectancy short form | Treatment Expectancy short form will assess feelings about treatment with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Feelings about the future using Positive Outlook short form | The Positive Outlook short form will assess feelings about the future with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Feelings about the future using Positive Outlook short form | The Positive Outlook short form will assess feelings about the future with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Feelings about the future using Positive Outlook short form | The Positive Outlook short form will assess feelings about the future with 6 multiple choice questions scaled from 1-5 with a maximum score of 30. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) | The COMM questionnaire will assess recent behaviors with 17 multiple choice questions. The minimum score is 0 and maximum score is 68. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) | The COMM questionnaire will assess recent behaviors with 17 multiple choice questions. The minimum score is 0 and maximum score is 68. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) | The COMM questionnaire will assess recent behaviors with 17 multiple choice questions. The minimum score is 0 and maximum score is 68. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale | The Subjective Opiate Withdrawal Scale will assess opioid withdrawal symptoms with 16 multiple choice questions. Each question is scored from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale | The Subjective Opiate Withdrawal Scale will assess opioid withdrawal symptoms with 16 multiple choice questions. Each question is scored from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale | The Subjective Opiate Withdrawal Scale will assess opioid withdrawal symptoms with 16 multiple choice questions. Each question is scored from 0-4 with a minimum score of 0 and maximum score of 64. Lower scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Task absorption using the Tellegen Absorption Scale (TAS) | The Tellegen Absorption Scale (TAS) will assess ability to become deeply involved in a task or an aspect of the environment with 34 true or false questions. Each true answer selection is indicated by 1 and each false answer selection is indicated by a 0. The minimum score is 0 and maximum score is 34. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 0 | 
| Assessment of Task absorption using the Tellegen Absorption Scale (TAS) | The Tellegen Absorption Scale (TAS) will assess ability to become deeply involved in a task or an aspect of the environment with 34 true or false questions. Each true answer selection is indicated by 1 and each false answer selection is indicated by a 0. The minimum score is 0 and maximum score is 34. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 4 | 
| Assessment of Task absorption using the Tellegen Absorption Scale (TAS) | The Tellegen Absorption Scale (TAS) will assess ability to become deeply involved in a task or an aspect of the environment with 34 true or false questions. Each true answer selection is indicated by 1 and each false answer selection is indicated by a 0. The minimum score is 0 and maximum score is 34. Higher scores suggest better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | Week 8 | 
| Assessment of Pain level before vs after intervention via Flowly app | Subjects will rate their current pain level on the Flowly app on a 0-10 Visual Analog Scale (VAS) with 0 being the least pain and 10 being the worst pain before vs after each VR treatment. Lower scores after intervention compared to before intervention indicate better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | daily, up to 8 weeks | 
| Assessment of Anxiety level before vs after intervention via Flowly app | Subjects will rate their current anxiety level on the Flowly app on a 0-10 Visual Analog Scale (VAS) with 0 being the least anxiety and 10 being the worst anxiety before vs after each VR treatment. Lower scores after intervention compared to before intervention indicate better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | daily, up to 8 weeks | 
| Assessment of Depression level before vs after intervention via Flowly app | Subjects will rate their current depression level on the Flowly app on a 0-10 Visual Analog Scale (VAS) with 0 being the least depression and 10 being the worst depression before vs after each VR treatment. Lower scores after intervention compared to before intervention indicate better outcomes. Outcomes will be measured over the span of the study and compared between the two groups. | daily, up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Autonomic Neuromodulation Induced Systemic Healing, TMC-CP01