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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43NR017575-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Colorado, Boulder | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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Participants with chronic back pain will complete an online eligibility questionnaire. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period") during which they complete a daily pain survey. Following the Baseline Period all participants complete an MRI scan. After the MRI, scan participants are randomized into a treatment group ("Therapy Group") or a no-intervention group ("Standard of Care Group" or "SOC Group") with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive education about chronic pain. They also participate in sessions to personalize their Virtual Reality (VR) experience, and to complete training on the use of the VR hardware and software. Therapy Group participants complete the treatment for 8 weeks ("Therapy Period"), after which they return the VR equipment. All participants take a second MRI scan approximately 8-weeks after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After the Therapy Period, Therapy Group participants continue to complete daily pain surveys during a two-week follow-up period ("Follow-Up Period"). All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and before and after the Follow-Up Period. For Therapy Group participants the study ends with the final surveys and an exit interview at the end of the Follow-up Period. Study Extension (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those who elect to do so will complete the same set of surveys as the Therapy Group did during the treatment phase; however, since there is no comparison group, data from this study extension is not used in the main outcomes analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Group | Experimental | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. |
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| Standard of Care (SOC) Group | No Intervention | The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Therapy for Chronic Pain | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity and Interference. | Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. | Change from pre-treatment to post-treatment = 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life. | Quality of Life (HRQoL SF-12) Questionnaire: yes / no questions and 3-point / 6-point Likert Scale questions; e.g., 1 = [negative impact] all of the time (worse outcome), 6 = [negative impact] none of the time. HRQoL results in two sub-scales / components (Physical and Mental). The mean of these was taken to result in a single value. | Baseline (average of survey data at beginning and end of a 2-week baseline period) and at the end of the 8 week therapy / control period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Bothersomeness. | Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Medications and Therapies. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Ceko, Ph.D. | University of Colorado, Boulder | Principal Investigator |
| Lynn Webster, MD | CognifiSense Inc. | Principal Investigator |
| Tassilo Baeuerle | CognifiSense Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Boulder | Boulder | Colorado | 80301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27002445 | Background | Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323. | |
| 38466872 | Derived | Ceko M, Baeuerle T, Webster L, Wager TD, Lumley MA. The effects of virtual reality neuroscience-based therapy on clinical and neuroimaging outcomes in patients with chronic back pain: a randomized clinical trial. Pain. 2024 Aug 1;165(8):1860-1874. doi: 10.1097/j.pain.0000000000003198. Epub 2024 Mar 8. |
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Of 1,346 applicants, 270 met inclusion criteria. Of these, 72 were enrolled in the study; however, 11 withdrew before start / randomization. 61 participants started the study (completed randomization). After a 2-week baseline period, participants were randomized into the Experimental and No Intervention Groups.
Participants were recruited via online (e.g., social media) advertising between December 2019 and September 2020. The first participant was enrolled on June 9, 2020, and the last participant was enrolled in October 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy Group | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises |
| FG001 | Standard of Care (SOC) Group | The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy Group | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Intensity and Interference. | Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. | Posted | Mean | Standard Deviation | units on a scale | Change from pre-treatment to post-treatment = 8 weeks. |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy Group | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marta Ceko | University of Colorado, Boulder | 443-835-6587 | Marta.Ceko@colorado.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2020 | May 27, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2022 | May 27, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2020 | Jun 30, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in Back Pain Disability. | Oswestry Low Back Pain Disability Questionnaire (OLBPD). 6-point Likert Scale questions on impact of pain on various life aspects; e.g., 1 = no negative impact, 6 = prevents normal activity (worse outcome). Participants completed questionnaire at the beginning and end of a 2-week baseline period and at the end of the 8 week therapy / control period. The starting values were the average of the two reported pain measures at the beginning and end of the baseline period | Change from pre-treatment to post-treatment = 8 weeks. |
A questionnaire asking participants to list the type and dosage / frequency of medication and therapies the participant is using for their back pain and for any other medical conditions. The list and dosage of medications and the type and frequencies of therapies will be compared pre- and post-treatment (8-week interval) to assess change in other pain therapies.
| Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Pain Catastrophizing. | Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Fear of Pain. | Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Fear of Movement. | Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Sleep Quality. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Sleep Disturbance: 8 items. 5-point Likert scales: 5 = not at all, 1 = very much (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Fatigue Symptoms. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Fatigue: 8 items. 5-point Likert scales: 1 = not at all, 5 = very much (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Depression. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Pain Attitudes. | Survey of Pain Attitudes (SOPA) Short Form. 6-point Likert scale: 5 = This is very untrue for me, 1 = This is very true for me [worse outcome]. | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Self-efficacy. | General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true [worse outcome], 4 = exactly true. | Change from pre-treatment to post-treatment = 8 weeks. |
| Expectations of Treatment Success. | Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome). | Before Therapy Period begins (pre-treatment; after 2-week baseline). |
| Impression of Treatment Success. | Patient Global Impression of Change (PGIC). 7-point scale: 0 = no change (condition has got worse [worst outcome]), 10 = a great deal better, and a considerable improvement that has made all the difference. | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
| Change in Optimism | Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Emotion Regulation. | Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Mindfulness. | Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never. | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Pain Coping Strategies. | Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question). | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Structural (Brain) MRI. | Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment. | Change from pre-treatment to post-treatment = 8 weeks. |
| Change in Resting-State Functional MRI. | Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment. | from pre-treatment to post-treatment = 8 weeks. |
| Change in Diffusion Tensor Imaging (DTI) MRI. | Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment. | Change from pre-treatment to post-treatment = 8 weeks. |
| Assessment of Usability of VR Device. | Questionnaire with 10 questions on usability of the VR device; 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree (worse outcome is a function of the question). | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
| Assessment of Sense of Presence in the VR Environment. | Questionnaire with 14 questions about the participant's sense of presence in the virtual environment - based on IGP Presence Questionnaire; 5-point Likert scale: 1 = fully disagree, 5 = fully agree (worse outcome is a function of the question). | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
| Assessment of Sense of Embodiment in the VR Environment. | Questionnaire with 10 questions about the participant's sense of embodiment in the virtual reality environment - based on the Gonzalez-Franko Embodiment Questionnaire; 7-point Likert scale from -3 = strongly disagree to +3 = strongly agree (worse outcome is a function of the question). | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study) |
| BG001 | Standard of Care (SOC) Group | The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Standard of Care (SOC) Group | The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. |
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| Secondary | Change in Quality of Life. | Quality of Life (HRQoL SF-12) Questionnaire: yes / no questions and 3-point / 6-point Likert Scale questions; e.g., 1 = [negative impact] all of the time (worse outcome), 6 = [negative impact] none of the time. HRQoL results in two sub-scales / components (Physical and Mental). The mean of these was taken to result in a single value. | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline (average of survey data at beginning and end of a 2-week baseline period) and at the end of the 8 week therapy / control period. |
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| Secondary | Change in Back Pain Disability. | Oswestry Low Back Pain Disability Questionnaire (OLBPD). 6-point Likert Scale questions on impact of pain on various life aspects; e.g., 1 = no negative impact, 6 = prevents normal activity (worse outcome). Participants completed questionnaire at the beginning and end of a 2-week baseline period and at the end of the 8 week therapy / control period. The starting values were the average of the two reported pain measures at the beginning and end of the baseline period | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Change from pre-treatment to post-treatment = 8 weeks. |
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| Other Pre-specified | Change in Pain Bothersomeness. | Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Medications and Therapies. | A questionnaire asking participants to list the type and dosage / frequency of medication and therapies the participant is using for their back pain and for any other medical conditions. The list and dosage of medications and the type and frequencies of therapies will be compared pre- and post-treatment (8-week interval) to assess change in other pain therapies. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Pain Catastrophizing. | Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Fear of Pain. | Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Fear of Movement. | Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Sleep Quality. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Sleep Disturbance: 8 items. 5-point Likert scales: 5 = not at all, 1 = very much (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Fatigue Symptoms. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Fatigue: 8 items. 5-point Likert scales: 1 = not at all, 5 = very much (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Depression. | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Pain Attitudes. | Survey of Pain Attitudes (SOPA) Short Form. 6-point Likert scale: 5 = This is very untrue for me, 1 = This is very true for me [worse outcome]. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Self-efficacy. | General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true [worse outcome], 4 = exactly true. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Expectations of Treatment Success. | Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome). | Not Posted | Before Therapy Period begins (pre-treatment; after 2-week baseline). | Participants |
| Other Pre-specified | Impression of Treatment Success. | Patient Global Impression of Change (PGIC). 7-point scale: 0 = no change (condition has got worse [worst outcome]), 10 = a great deal better, and a considerable improvement that has made all the difference. | Not Posted | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). | Participants |
| Other Pre-specified | Change in Optimism | Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Emotion Regulation. | Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Mindfulness. | Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Pain Coping Strategies. | Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question). | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Structural (Brain) MRI. | Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Resting-State Functional MRI. | Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment. | Not Posted | from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Change in Diffusion Tensor Imaging (DTI) MRI. | Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment. | Not Posted | Change from pre-treatment to post-treatment = 8 weeks. | Participants |
| Other Pre-specified | Assessment of Usability of VR Device. | Questionnaire with 10 questions on usability of the VR device; 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree (worse outcome is a function of the question). | Not Posted | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). | Participants |
| Other Pre-specified | Assessment of Sense of Presence in the VR Environment. | Questionnaire with 14 questions about the participant's sense of presence in the virtual environment - based on IGP Presence Questionnaire; 5-point Likert scale: 1 = fully disagree, 5 = fully agree (worse outcome is a function of the question). | Not Posted | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). | Participants |
| Other Pre-specified | Assessment of Sense of Embodiment in the VR Environment. | Questionnaire with 10 questions about the participant's sense of embodiment in the virtual reality environment - based on the Gonzalez-Franko Embodiment Questionnaire; 7-point Likert scale from -3 = strongly disagree to +3 = strongly agree (worse outcome is a function of the question). | Not Posted | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study) | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Standard of Care (SOC) Group | The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. | 0 | 30 | 0 | 30 | 0 | 30 |
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