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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 (VANISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236804
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aman Mahajan, University of Pittsburgh

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 increase pain management and decrease daily dosages of opioids.


Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Device: Flowly (TMC-CP01) Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: TMC-CP01 Intervention
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)
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.
Other Name: Virtual Reality

No Intervention: Standard of Care
Ten patients will be randomly assigned to receive their current opioid prescription and tapering guidelines, as standard of care.



Primary Outcome Measures :
  1. Flowly (TMC-CP01) virtual reality intervention feasibility via Change From Baseline in Heart Rate Variability at 8 Weeks [ Time Frame: 8 Weeks ]
    Feasibility outcomes of the Flowly (TMC-CP01) virtual reality treatment intervention will be measured 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.


Secondary Outcome Measures :
  1. Assessment of Opioid Cravings using the Craving Index [ Time Frame: weekly, up to 8 weeks ]
    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.

  2. Assessment of Physical Function using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  3. Assessment of Fatigue using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  4. Assessment of Pain Interference using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  5. Assessment of Pain Intensity using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  6. Assessment of Sleep Disturbance using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  7. Assessment of Ability to Participate in Social Roles and Activities using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  8. Assessment of Depression using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  9. Assessment of Anxiety using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  10. Assessment of Loneliness using PROMIS [ Time Frame: weekly, up to 8 weeks ]
    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.

  11. Assessment of feelings about pain [ Time Frame: Week 0 ]
    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.

  12. Assessment of feelings about pain [ Time Frame: Week 4 ]
    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.

  13. Assessment of feelings about pain [ Time Frame: Week 8 ]
    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.

  14. Assessment of Opioid use via subject report [ Time Frame: Week 0 ]
    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.

  15. Assessment of Opioid use via subject report [ Time Frame: Week 4 ]
    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.

  16. Assessment of Opioid use via subject report [ Time Frame: Week 8 ]
    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.

  17. Assessment of Salivary cortisol levels [ Time Frame: Week 0 ]
    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.

  18. Assessment of Salivary cortisol levels [ Time Frame: Week 4 ]
    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.

  19. Assessment of Salivary cortisol levels [ Time Frame: Week 8 ]
    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.

  20. Assessment of Opioid use via urinalysis [ Time Frame: Week 0 ]
    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.

  21. Assessment of Opioid use via urinalysis [ Time Frame: Week 4 ]
    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.

  22. Assessment of Opioid use via urinalysis [ Time Frame: Week 8 ]
    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.

  23. Assessment of Withdrawal symptoms using Opiate Withdrawal Scale [ Time Frame: Week 0 ]
    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.

  24. Assessment of Withdrawal symptoms using Opiate Withdrawal Scale [ Time Frame: Week 4 ]
    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.

  25. Assessment of Withdrawal symptoms using Opiate Withdrawal Scale [ Time Frame: Week 8 ]
    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.

  26. Assessment of Beliefs about pain using Pain Catastrophizing Scale [ Time Frame: Week 0 ]
    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.

  27. Assessment of Beliefs about pain using Pain Catastrophizing Scale [ Time Frame: Week 4 ]
    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.

  28. Assessment of Beliefs about pain using Pain Catastrophizing Scale [ Time Frame: Week 8 ]
    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.

  29. Assessment of Feelings about treatment using Treatment Expectancy short form [ Time Frame: Week 0 ]
    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.

  30. Assessment of Feelings about treatment using Treatment Expectancy short form [ Time Frame: Week 4 ]
    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.

  31. Assessment of Feelings about treatment using Treatment Expectancy short form [ Time Frame: Week 8 ]
    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.

  32. Assessment of Feelings about the future using Positive Outlook short form [ Time Frame: Week 0 ]
    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.

  33. Assessment of Feelings about the future using Positive Outlook short form [ Time Frame: Week 4 ]
    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.

  34. Assessment of Feelings about the future using Positive Outlook short form [ Time Frame: Week 8 ]
    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.

  35. Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) [ Time Frame: Week 0 ]
    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.

  36. Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) [ Time Frame: Week 4 ]
    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.

  37. Assessment of recent behaviors using the Current Opioid Misuse Measure (COMM) [ Time Frame: Week 8 ]
    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.

  38. Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale [ Time Frame: Week 0 ]
    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.

  39. Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale [ Time Frame: Week 4 ]
    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.

  40. Assessment of Opioid withdrawal symptoms using the Subjective Opiate Withdrawal Scale [ Time Frame: Week 8 ]
    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.

  41. Assessment of Task absorption using the Tellegen Absorption Scale (TAS) [ Time Frame: Week 0 ]
    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.

  42. Assessment of Task absorption using the Tellegen Absorption Scale (TAS) [ Time Frame: Week 4 ]
    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.

  43. Assessment of Task absorption using the Tellegen Absorption Scale (TAS) [ Time Frame: Week 8 ]
    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.

  44. Assessment of Pain level before vs after intervention via Flowly app [ Time Frame: daily, up to 8 weeks ]
    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.

  45. Assessment of Anxiety level before vs after intervention via Flowly app [ Time Frame: daily, up to 8 weeks ]
    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.

  46. Assessment of Depression level before vs after intervention via Flowly app [ Time Frame: daily, up to 8 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236804


Contacts
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Contact: Melanie Driscoll 412-728-8689 driscollms2@upmc.edu
Contact: Amy Monroe 412-609-6161 moroeal@upmc.edu

Locations
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United States, Pennsylvania
UPMC Pain Medicine At Centre Commons
Pittsburgh, Pennsylvania, United States, 15206
Contact: Ashley Yu-Ting Huang       AYH15@pitt.edu   
Contact: Andrea Gillman    412-665-2904    gillmana@pitt.edu   
Principal Investigator: Aman Mahajan, MD, PhD, MBA         
Sub-Investigator: Ajay Wasan, MD, MSc         
Sponsors and Collaborators
Aman Mahajan
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Aman Mahajan, MD, PhD, MBA University of Pittsburgh

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Responsible Party: Aman Mahajan, Department Chair and Director of Perioperative Services, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04236804    
Other Study ID Numbers: STUDY19050295
1R44DA049630-01 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Aman Mahajan, University of Pittsburgh:
Virtual Autonomic Neuromodulation Induced Systemic Healing
TMC-CP01
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents