Chronic Low-back Pain
Conditions
Keywords
Virtual Autonomic Neuromodulation Induced Systemic Healing, TMC-CP01
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.
Interventions
DEVICEFlowly (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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Ajay Wasan, MD, Msc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Opioid Use Via Subject Report | Week 0 | Daily dose of oral opioids recorded as morphine equivalents will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flowly (TMC-CP01) Virtual Reality Intervention Feasibility Via Change From Baseline in Heart Rate Variability (HRV) at 8 Weeks | 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. |
| Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks | weekly, up to 8 weeks | The Craving Index questionnaire on the Flowly app assesses opioid cravings using 6 qualitatively scaled questions, ranging from 'none' (minimum score: 0) to 'the greatest possibility' (maximum score: 5 per question, total score: 30). Lower scores indicate less frequent opioid cravings, suggesting better outcomes. Measurements were assessed weekly, and the analysis focused on comparing scores between baseline and 8 weeks to evaluate changes in cravings between the two groups. |
| Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Physical Function Short Form T-score to assess key patient-centered outcomes related to physical function. This assessment includes 4 physical function-related questions, each scored on a 5-point Likert scale (1 = unable to do, 5 = without any difficulty). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate better physical function, while lower T-scores suggest worse physical function. Clinically relevant thresholds may indicate that lower scores are associated with greater physical disability. Measurements were conducted at baseline and Week 8, with the analysis focused on comparing changes in physical function between the two groups. |
| Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks | Baseline and Week 8 | The investigators used the PROMIS Fatigue Short Form T-score to assess key patient-centered outcomes related to fatigue. This assessment includes 4 fatigue-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate greater fatigue, while lower T-scores suggest less fatigue, which reflects better outcomes. Clinically relevant thresholds suggest that elevated T-scores may indicate increased fatigue severity. Measurements were conducted at baseline and Week 8, with the analysis focused on comparing changes in fatigue levels between the two groups. |
| Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Pain Interference Short Form to assess how pain impacts daily activities. This measure includes 5 pain-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score (range: 5 to 25) was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain interference, while lower T-scores suggest less interference (better outcomes). A T-score of 60+ may indicate clinically significant pain interference, while 40 or lower suggests minimal interference. Measurements were conducted over the study, with scores compared between baseline and 8 weeks to assess changes in pain interference. |
| Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Pain Intensity Item to assess patients' self-reported pain levels. This measure consists of one question, scored on an 11-point Likert scale (0 = no pain, 10 = worst imaginable pain). The raw score was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain intensity, while lower T-scores suggest less pain (better outcomes). A T-score of 60+ may indicate clinically significant pain, while 40 or lower suggests mild or minimal pain. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in pain intensity. |
| Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Sleep Disturbance Short Form to assess patient-reported sleep difficulties. This measure includes 4 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater sleep disturbance (worse outcomes), while lower T-scores suggest better sleep quality. A T-score of 60+ may indicate clinically significant sleep disturbance, while 40 or lower suggests minimal issues. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in sleep disturbance. |
| Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Ability to Participate in Social Roles and Activities Short Form to assess social participation. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater ability to engage in social roles and activities (better outcomes), while lower scores suggest more social restrictions. A T-score below 40 may indicate clinically significant limitations in social participation. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in social participation. |
| Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Depression Short Form to assess depressive symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of depression (worse outcomes), while lower scores reflect fewer depressive symptoms. A T-score above 60 suggests clinically significant depression, while a T-score below 50 reflects better mental health relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in depressive symptoms. |
| Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Anxiety Short Form to assess anxiety symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of anxiety (worse outcomes), while lower scores reflect reduced anxiety symptoms. A T-score above 60 suggests clinically significant anxiety, while a T-score below 50 reflects better emotional health relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in anxiety symptoms. |
| Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks | Assessed weekly, change from baseline and Week 8 reported | The investigators used the PROMIS Emotional Support Short Form to assess patient-centered outcomes related to loneliness. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater loneliness (worse outcomes), while lower scores suggest better emotional support. A T-score above 60 suggests clinically significant loneliness, while a T-score below 50 reflects better perceived emotional support relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in loneliness. |
| Assessment of Feelings About Pain | Week 0 | The investigators will use the PainDetect Questionnaire, a validated tool to assess patients' perceptions and feelings about pain. The questionnaire includes 15 multiple-choice questions and a drawing of localized pain, yielding a total score that ranges from 0 (minimum) to 38 (maximum). Lower scores indicate less neuropathic pain and suggest better outcomes. |
| Assessment of Salivary Cortisol Levels | Week 0 | The investigators will measure subjects' salivary cortisol levels using validated laboratory techniques. Cortisol levels are reported in micrograms per deciliter (mcg/dL) and have no predefined minimum or maximum values. Lower cortisol levels indicate better outcomes. |
| Assessment of Opioid Use Via Urinalysis | 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. |
| Assessment of Opioid Use Via Subject Report | 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. |
| Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | Week 0 | The Pain Catastrophizing Scale (PCS) will assess subjects' beliefs about pain using 13 multiple-choice questions, each scored from 1 (not at all) to 5 (all the time). The total score ranges from a minimum of 13 to a maximum of 65. Lower scores indicate better outcomes and less catastrophizing about pain. |
| Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0 | Week 0 | The Treatment Expectancy Short Form assesses subjects' expectations and confidence in their treatment using 6 items, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy. |
| Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4 | Week 4 | The Treatment Expectancy Short Form assesses subjects' expectations and confidence in their treatment using 6 items, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy. |
| Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8 | Week 8 | The Treatment Expectancy Short Form evaluates subjects' expectations and confidence in their treatment using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy. |
| Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0 | Week 0 | The Positive Outlook Short Form measures subjects' perceptions and feelings about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations. |
| Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4 | Week 4 | The Positive Outlook Short Form measures subjects' perceptions and feelings about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations. |
| Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8 | Week 8 | The Positive Outlook Short Form evaluates subjects' perceptions and expectations about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations. |
| Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | Week 0 | The Current Opioid Misuse Measure (COMM) questionnaire assesses recent behaviors using 17 multiple-choice questions, with scores ranging from a minimum of 0 to a maximum of 68. Lower scores suggest better outcomes and less likelihood of opioid misuse. |
| Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0 | Week 0 | The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions. |
| Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4 | Week 4 | The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions. |
| Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8 | Week 8 | The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions. |
| Change in Pain Level Before vs After Intervention Via Flowly App | Baseline and Week 8 (Week 8 value is the average of daily scores from that week) | Subjects rated their current pain level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no pain and 10 represents the worst imaginable pain. Pain scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, pain scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in pain levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater pain intensity, while lower scores suggest better outcomes (i.e., pain reduction). |
| Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App | Baseline and Week 8 (Week 8 value is the average of daily scores from that week) | Subjects rated their current anxiety level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no anxiety and 10 represents the worst imaginable anxiety. Anxiety scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, anxiety scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in anxiety levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater anxiety levels, while lower scores suggest better outcomes (i.e., anxiety reduction). |
| Change in Depression Level From Baseline to 8 Weeks Via Flowly App | Baseline and Week 8 (Week 8 value is the average of daily scores from that week) | Subjects rated their current depression level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no depression and 10 represents the worst imaginable depression. Depression scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, depression scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in depression levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater depression levels, while lower scores suggest better outcomes (i.e., depression reduction). |
| Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | Week 0 | The Subjective Opiate Withdrawal Scale (SOWS) will assess subjects' withdrawal symptoms using 16 multiple-choice questions, each scored from 0 (not at all) to 4 (extremely). The total score ranges from a minimum of 0 to a maximum of 64. Lower scores indicate better outcomes and fewer withdrawal symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| Standard of Care Ten patients will be randomly assigned to receive their current opioid prescription and tapering guidelines, as standard of care. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | TMC-CP01 Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 55.70 Years STANDARD_DEVIATION 14.3 | 58.8 Years STANDARD_DEVIATION 10.11 | 57.25 Years STANDARD_DEVIATION 12.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Assessment of Opioid Use Via Subject Report
Daily dose of oral opioids recorded as morphine equivalents will be collected
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Opioid Use Via Subject Report | 47.5 morphine milligram equivalent | Standard Deviation 36.53 |
| Standard of Care | Assessment of Opioid Use Via Subject Report | 21.75 morphine milligram equivalent | Standard Deviation 23.19 |
Secondary
Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) will assess subjects' beliefs about pain using 13 multiple-choice questions, each scored from 1 (not at all) to 5 (all the time). The total score ranges from a minimum of 13 to a maximum of 65. Lower scores indicate better outcomes and less catastrophizing about pain.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 27.1 score on a scale | Standard Deviation 9.48 |
| Standard of Care | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 23.71 score on a scale | Standard Deviation 7.83 |
Secondary
Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) will assess subjects' beliefs about pain using 13 multiple-choice questions, each scored from 1 (not at all) to 5 (all the time). The total score ranges from a minimum of 13 to a maximum of 65. Lower scores indicate better outcomes and less catastrophizing about pain.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 31.33 score on a scale | Standard Deviation 9.12 |
| Standard of Care | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 25.8 score on a scale | Standard Deviation 10.9 |
Secondary
Assessment of Beliefs About Pain Using Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) will assess subjects' beliefs about pain using 13 multiple-choice questions, each scored from 1 (not at all) to 5 (all the time). The total score ranges from a minimum of 13 to a maximum of 65. Lower scores indicate better outcomes and less catastrophizing about pain.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 34.4 score on a scale | Standard Deviation 10.01 |
| Standard of Care | Assessment of Beliefs About Pain Using Pain Catastrophizing Scale | 25.29 score on a scale | Standard Deviation 7.54 |
Secondary
Assessment of Feelings About Pain
The investigators will use the PainDetect Questionnaire, a validated tool to assess patients' perceptions and feelings about pain. The questionnaire includes 15 multiple-choice questions and a drawing of localized pain, yielding a total score that ranges from 0 (minimum) to 38 (maximum). Lower scores indicate less neuropathic pain and suggest better outcomes.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Feelings About Pain | 14.9 score on a scale | Standard Deviation 8.16 |
| Standard of Care | Assessment of Feelings About Pain | 16.5 score on a scale | Standard Deviation 8.04 |
Secondary
Assessment of Feelings About Pain
The investigators will use the PainDetect Questionnaire, a validated tool to assess patients' perceptions and feelings about pain. The questionnaire includes 15 multiple-choice questions and a drawing of localized pain, yielding a total score that ranges from 0 (minimum) to 38 (maximum). Lower scores indicate less neuropathic pain and suggest better outcomes.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Feelings About Pain | 16.9 score on a scale | Standard Deviation 9.57 |
| Standard of Care | Assessment of Feelings About Pain | 16.8 score on a scale | Standard Deviation 10.73 |
Secondary
Assessment of Feelings About Pain
The investigators will use the PainDetect Questionnaire, a validated tool to assess patients' perceptions and feelings about pain. The questionnaire includes 15 multiple-choice questions and a drawing of localized pain, yielding a total score that ranges from 0 (minimum) to 38 (maximum). Lower scores indicate less neuropathic pain and suggest better outcomes.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Feelings About Pain | 16.89 score on a scale | Standard Deviation 7.06 |
| Standard of Care | Assessment of Feelings About Pain | 17 score on a scale | Standard Deviation 5.29 |
Secondary
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Opioid Use Via Subject Report | 47.27 MME | Standard Deviation 36.77 |
| Standard of Care | Assessment of Opioid Use Via Subject Report | 10.62 MME | Standard Deviation 7.36 |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Opioid Use Via Subject Report | 47.27 MME | Standard Deviation 36.77 |
| Standard of Care | Assessment of Opioid Use Via Subject Report | 10.75 MME | Standard Deviation 7.34 |
Secondary
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.
Time frame: Week 8
Population: Urine drug screen data were not collected due to two key barriers: (1) the clinical personnel required to administer the tests were not consistently available during study visits, and (2) the cost of performing quantitative urine drug screens for each participant was beyond the scope of the study's budget. As a result, no data are available for this outcome.
Secondary
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.
Time frame: Week 0
Population: Urine drug screen data were not collected due to two key barriers: (1) the clinical personnel required to administer the tests were not consistently available during study visits, and (2) the cost of performing quantitative urine drug screens for each participant was beyond the scope of the study's budget. As a result, no data are available for this outcome.
Secondary
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.
Time frame: Week 4
Population: Urine drug screen data were not collected due to two key barriers: (1) the clinical personnel required to administer the tests were not consistently available during study visits, and (2) the cost of performing quantitative urine drug screens for each participant was beyond the scope of the study's budget. As a result, no data are available for this outcome.
Secondary
Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0
The Positive Outlook Short Form measures subjects' perceptions and feelings about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0 | 46.06 T-score | Standard Deviation 9.53 |
| Standard of Care | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0 | 50.22 T-score | Standard Deviation 11.77 |
Secondary
Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4
The Positive Outlook Short Form measures subjects' perceptions and feelings about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4 | 46.77 T-score | Standard Deviation 6.47 |
| Standard of Care | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4 | 53.43 T-score | Standard Deviation 17.6 |
Secondary
Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8
The Positive Outlook Short Form evaluates subjects' perceptions and expectations about the future using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater optimism and a more positive outlook, suggesting better psychological well-being. Lower T-scores reflect greater pessimism or concerns about the future. A T-score above 60 may indicate high optimism, while a T-score below 40 suggests low optimism or increased negative expectations.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8 | 46.86 T-score | Standard Deviation 8.89 |
| Standard of Care | Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8 | 50.48 T-score | Standard Deviation 12.21 |
Secondary
Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse Measure (COMM) questionnaire assesses recent behaviors using 17 multiple-choice questions, with scores ranging from a minimum of 0 to a maximum of 68. Lower scores suggest better outcomes and less likelihood of opioid misuse.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 10.10 score on a scale | Standard Deviation 7.36 |
| Standard of Care | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 3.17 score on a scale | Standard Deviation 2.93 |
Secondary
Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse Measure (COMM) questionnaire assesses recent behaviors using 17 multiple-choice questions, with scores ranging from a minimum of 0 to a maximum of 68. Lower scores suggest better outcomes and less likelihood of opioid misuse.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 7.89 score on a scale | Standard Deviation 5.78 |
| Standard of Care | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 6 score on a scale | Standard Deviation 2 |
Secondary
Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse Measure (COMM) questionnaire assesses recent behaviors using 17 multiple-choice questions, with scores ranging from a minimum of 0 to a maximum of 68. Lower scores suggest better outcomes and less likelihood of opioid misuse.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 11 score on a scale | Standard Deviation 6.07 |
| Standard of Care | Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM) | 9 score on a scale | Standard Deviation 5.93 |
Secondary
Assessment of Salivary Cortisol Levels
The investigators will measure subjects' salivary cortisol levels using validated laboratory techniques. Cortisol levels are reported in micrograms per deciliter (mcg/dL) and have no predefined minimum or maximum values. Lower cortisol levels indicate better outcomes.
Time frame: Week 4
Population: Data were not collected at Week 4 because salivary cortisol levels were only measured at baseline (Week 0) and the study endpoint (Week 8). No data exist for this time point.
Secondary
Assessment of Salivary Cortisol Levels
The investigators will measure subjects' salivary cortisol levels using validated laboratory techniques. Cortisol levels are reported in micrograms per deciliter (mcg/dL) and have no predefined minimum or maximum values. Lower cortisol levels indicate better outcomes.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Salivary Cortisol Levels | 3.68 mcg/dL | Standard Deviation 2.32 |
| Standard of Care | Assessment of Salivary Cortisol Levels | 5.07 mcg/dL | Standard Deviation 5.06 |
Secondary
Assessment of Salivary Cortisol Levels
The investigators will measure subjects' salivary cortisol levels using validated laboratory techniques. Cortisol levels are reported in micrograms per deciliter (mcg/dL) and have no predefined minimum or maximum values. Lower cortisol levels indicate better outcomes.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Salivary Cortisol Levels | 6.72 mcg/dL | Standard Deviation 5.73 |
| Standard of Care | Assessment of Salivary Cortisol Levels | 8.38 mcg/dL | Standard Deviation 9.15 |
Secondary
Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0
The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0 | 10.2 Units on a scale | Standard Deviation 7.41 |
| Standard of Care | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0 | 14.3 Units on a scale | Standard Deviation 8.53 |
Secondary
Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4
The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4 | 9.22 Units on a scale | Standard Deviation 8.15 |
| Standard of Care | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4 | 17.67 Units on a scale | Standard Deviation 8.02 |
Secondary
Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8
The Tellegen Absorption Scale (TAS) assesses an individual's ability to become deeply engaged in a task or an aspect of their environment. The scale consists of 34 true-or-false items, where each true response is scored as 1, and each false response is scored as 0. The total score ranges from 0 to 34, with higher scores indicating a greater capacity for absorption and immersive engagement. This measure evaluates attentional focus and deep engagement in activities, which may be relevant for assessing response to virtual reality interventions.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8 | 8.4 Units on a scale | Standard Deviation 7.15 |
| Standard of Care | Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8 | 16 Units on a scale | Standard Deviation 7.92 |
Secondary
Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0
The Treatment Expectancy Short Form assesses subjects' expectations and confidence in their treatment using 6 items, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0 | 50.19 t-score | Standard Deviation 6.03 |
| Standard of Care | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0 | 51.33 t-score | Standard Deviation 5.7 |
Secondary
Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4
The Treatment Expectancy Short Form assesses subjects' expectations and confidence in their treatment using 6 items, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4 | 46.04 t-score | Standard Deviation 6.95 |
| Standard of Care | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4 | 51.43 t-score | Standard Deviation 5.45 |
Secondary
Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8
The Treatment Expectancy Short Form evaluates subjects' expectations and confidence in their treatment using 6 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 6 to 30) is converted to a T-score (mean = 50, SD = 10) for standardized interpretation. Higher T-scores indicate greater treatment expectancy, suggesting more positive beliefs about treatment efficacy. Lower T-scores reflect greater skepticism or uncertainty. A T-score above 60 may indicate high confidence in treatment, while a T-score below 40 suggests low expectancy.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8 | 50.48 T-score | Standard Deviation 8.65 |
| Standard of Care | Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8 | 43.98 T-score | Standard Deviation 10.21 |
Secondary
Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
The Subjective Opiate Withdrawal Scale (SOWS) will assess subjects' withdrawal symptoms using 16 multiple-choice questions, each scored from 0 (not at all) to 4 (extremely). The total score ranges from a minimum of 0 to a maximum of 64. Lower scores indicate better outcomes and fewer withdrawal symptoms.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 7.67 score on a scale | Standard Deviation 4.82 |
| Standard of Care | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 14 score on a scale | Standard Deviation 18.52 |
Secondary
Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
The Subjective Opiate Withdrawal Scale (SOWS) will assess subjects' withdrawal symptoms using 16 multiple-choice questions, each scored from 0 (not at all) to 4 (extremely). The total score ranges from a minimum of 0 to a maximum of 64. Lower scores indicate better outcomes and fewer withdrawal symptoms.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 8 score on a scale | Standard Deviation 5.37 |
| Standard of Care | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 3.7 score on a scale | Standard Deviation 2.83 |
Secondary
Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale
The Subjective Opiate Withdrawal Scale (SOWS) will assess subjects' withdrawal symptoms using 16 multiple-choice questions, each scored from 0 (not at all) to 4 (extremely). The total score ranges from a minimum of 0 to a maximum of 64. Lower scores indicate better outcomes and fewer withdrawal symptoms.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 7.6 score on a scale | Standard Deviation 6.35 |
| Standard of Care | Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale | 5.67 score on a scale | Standard Deviation 6.92 |
Secondary
Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks
The investigators used the PROMIS Ability to Participate in Social Roles and Activities Short Form to assess social participation. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater ability to engage in social roles and activities (better outcomes), while lower scores suggest more social restrictions. A T-score below 40 may indicate clinically significant limitations in social participation. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in social participation.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks | 1.95 T-score | Standard Deviation 5 |
| Standard of Care | Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks | 0.04 T-score | Standard Deviation 4.23 |
Secondary
Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks
The investigators used the PROMIS Anxiety Short Form to assess anxiety symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of anxiety (worse outcomes), while lower scores reflect reduced anxiety symptoms. A T-score above 60 suggests clinically significant anxiety, while a T-score below 50 reflects better emotional health relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in anxiety symptoms.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks | -4.05 T-score | Standard Deviation 7.79 |
| Standard of Care | Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks | -2.62 T-score | Standard Deviation 5.59 |
Secondary
Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks
The investigators used the PROMIS Depression Short Form to assess depressive symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of depression (worse outcomes), while lower scores reflect fewer depressive symptoms. A T-score above 60 suggests clinically significant depression, while a T-score below 50 reflects better mental health relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in depressive symptoms.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks | -1.08 T-score | Standard Deviation 4.21 |
| Standard of Care | Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks | -3.22 T-score | Standard Deviation 6.35 |
Secondary
Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks
The investigators used the PROMIS Fatigue Short Form T-score to assess key patient-centered outcomes related to fatigue. This assessment includes 4 fatigue-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate greater fatigue, while lower T-scores suggest less fatigue, which reflects better outcomes. Clinically relevant thresholds suggest that elevated T-scores may indicate increased fatigue severity. Measurements were conducted at baseline and Week 8, with the analysis focused on comparing changes in fatigue levels between the two groups.
Time frame: Baseline and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks | 0.17 T-score | Standard Deviation 5.05 |
| Standard of Care | Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks | 0.61 T-score | Standard Deviation 8.09 |
Secondary
Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks
The investigators used the PROMIS Emotional Support Short Form to assess patient-centered outcomes related to loneliness. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater loneliness (worse outcomes), while lower scores suggest better emotional support. A T-score above 60 suggests clinically significant loneliness, while a T-score below 50 reflects better perceived emotional support relative to the general population. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in loneliness.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks | -2 T-score | Standard Deviation 4.08 |
| Standard of Care | Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks | -4 T-score | Standard Deviation 5.66 |
Secondary
Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks
The Craving Index questionnaire on the Flowly app assesses opioid cravings using 6 qualitatively scaled questions, ranging from 'none' (minimum score: 0) to 'the greatest possibility' (maximum score: 5 per question, total score: 30). Lower scores indicate less frequent opioid cravings, suggesting better outcomes. Measurements were assessed weekly, and the analysis focused on comparing scores between baseline and 8 weeks to evaluate changes in cravings between the two groups.
Time frame: weekly, up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks | 0.60 score on a scale | Standard Deviation 7.56 |
| Standard of Care | Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks | 0.83 score on a scale | Standard Deviation 4.92 |
Secondary
Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks
The investigators used the PROMIS Pain Intensity Item to assess patients' self-reported pain levels. This measure consists of one question, scored on an 11-point Likert scale (0 = no pain, 10 = worst imaginable pain). The raw score was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain intensity, while lower T-scores suggest less pain (better outcomes). A T-score of 60+ may indicate clinically significant pain, while 40 or lower suggests mild or minimal pain. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in pain intensity.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks | 0.2 T-score | Standard Deviation 1.32 |
| Standard of Care | Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks | 0.14 T-score | Standard Deviation 1.07 |
Secondary
Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks
The investigators used the PROMIS Pain Interference Short Form to assess how pain impacts daily activities. This measure includes 5 pain-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score (range: 5 to 25) was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain interference, while lower T-scores suggest less interference (better outcomes). A T-score of 60+ may indicate clinically significant pain interference, while 40 or lower suggests minimal interference. Measurements were conducted over the study, with scores compared between baseline and 8 weeks to assess changes in pain interference.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks | -1.47 T-score | Standard Deviation 3.69 |
| Standard of Care | Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks | -1.75 T-score | Standard Deviation 3.22 |
Secondary
Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks
The investigators used the PROMIS Physical Function Short Form T-score to assess key patient-centered outcomes related to physical function. This assessment includes 4 physical function-related questions, each scored on a 5-point Likert scale (1 = unable to do, 5 = without any difficulty). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate better physical function, while lower T-scores suggest worse physical function. Clinically relevant thresholds may indicate that lower scores are associated with greater physical disability. Measurements were conducted at baseline and Week 8, with the analysis focused on comparing changes in physical function between the two groups.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks | 0.07 T-score | Standard Deviation 2.89 |
| Standard of Care | Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks | -1.41 T-score | Standard Deviation 4.24 |
Secondary
Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks
The investigators used the PROMIS Sleep Disturbance Short Form to assess patient-reported sleep difficulties. This measure includes 4 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater sleep disturbance (worse outcomes), while lower T-scores suggest better sleep quality. A T-score of 60+ may indicate clinically significant sleep disturbance, while 40 or lower suggests minimal issues. Measurements were conducted throughout the study, with scores compared between baseline and 8 weeks to assess changes in sleep disturbance.
Time frame: Assessed weekly, change from baseline and Week 8 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks | -1.82 T-score | Standard Deviation 5.73 |
| Standard of Care | Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks | -0.47 T-score | Standard Deviation 4.51 |
Secondary
Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App
Subjects rated their current anxiety level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no anxiety and 10 represents the worst imaginable anxiety. Anxiety scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, anxiety scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in anxiety levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater anxiety levels, while lower scores suggest better outcomes (i.e., anxiety reduction).
Time frame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App | -4.05 Units on a scale | Standard Deviation 7.79 |
| Standard of Care | Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App | -2.62 Units on a scale | Standard Deviation 5.59 |
Secondary
Change in Depression Level From Baseline to 8 Weeks Via Flowly App
Subjects rated their current depression level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no depression and 10 represents the worst imaginable depression. Depression scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, depression scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in depression levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater depression levels, while lower scores suggest better outcomes (i.e., depression reduction).
Time frame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change in Depression Level From Baseline to 8 Weeks Via Flowly App | -1.08 Units on a scale | Standard Deviation 4.21 |
| Standard of Care | Change in Depression Level From Baseline to 8 Weeks Via Flowly App | -3.22 Units on a scale | Standard Deviation 6.35 |
Secondary
Change in Pain Level Before vs After Intervention Via Flowly App
Subjects rated their current pain level using the 0-10 Visual Analog Scale (VAS) within the Flowly app, where 0 represents no pain and 10 represents the worst imaginable pain. Pain scores were recorded immediately before and after each VR session, which took place daily throughout the study. For analysis, pain scores were assessed at baseline and at Week 8. The Week 8 value represents the average of daily post-session scores recorded during the final week of the study. The change in pain levels was calculated by comparing the baseline value to the Week 8 average. Higher scores indicate greater pain intensity, while lower scores suggest better outcomes (i.e., pain reduction).
Time frame: Baseline and Week 8 (Week 8 value is the average of daily scores from that week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMC-CP01 Intervention | Change in Pain Level Before vs After Intervention Via Flowly App | 0.2 Units on a scale | Standard Deviation 1.32 |
| Standard of Care | Change in Pain Level Before vs After Intervention Via Flowly App | 0.14 Units on a scale | Standard Deviation 1.07 |
Secondary
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.
Time frame: 8 Weeks
Population: HRV data were not collected due to a malfunction in the Flowly app, which was in beta testing during the study. The app was intended to collect HRV via a paired biometric sensor, but it failed to reliably communicate with the device. As a result, HRV measurements were not transmitted or stored, and no usable data were available for analysis.