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| Name | Class |
|---|---|
| Travelers | INDUSTRY |
| Samsung | INDUSTRY |
| AppliedVR Inc. | INDUSTRY |
| Bayer |
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This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Pain Reduction Kit | Experimental | Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. |
|
| Active Control | Active Comparator | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Pain Reduction Kit | Device | A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS - Physical Function Short Form 8b | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS - Pain Interference Short Form 8a | PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
Of 1156 patients assessed for eligibility, 245 met criteria and were randomized.
Initial Deployment: Inpatient trauma only, in-person recruitment of CSMC trauma patients with no opioid prescription. 3/28/2018 - 10/31/2018 Inpatient trauma + Pain Clinic. In-person recruitment of cLBP patients without opioid prescription at single CSMC pain specialty clinic. 11/1/2018 - 12/31/2018 Revised: Inpatient Trauma + Pain Clinic. Patients with opioid prescription allowed to participate. 1/1/2019 - 4/23/2019 Revised: Pain Clinic only, recruitment fully remote. 4/23/2019 - End
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Pain Reduction Kit | Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. |
| FG001 | Active Control | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inpatient Trauma Only |
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| |||||||||||||||||||||
| Inpatient Trauma+Pain Clinic, no Opioid |
| ||||||||||||||||||||||
| Inpatient Trauma+Pain Clinic |
| ||||||||||||||||||||||
| Pain Clinic Only, Fully Remote |
|
The analysis population includes all participants who responded to primary outcome survey during week 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Pain Reduction Kit | Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PROMIS - Physical Function Short Form 8b | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. | Participants with a week 1 response. | Posted | Mean | Standard Deviation | units on a scale | 60 days |
|
10 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 | Digital Pain Reduction Kit | Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain when using device | Product Issues | Non-systematic Assessment | - reported that when placing TENS device on low-low back (coccyx bulging disk) felt sharp pain, radiating down leg. Does not happen when placing device anywhere else, so recommended speaking with doctor; Withdrawn after speaking with Dr. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Brennan Spiegel | CedarsSinaiMC | 310-423-6784 | Brennan.Spiegel@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 | May 6, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2019 | May 6, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hollywog | INDUSTRY |
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| Active Control | Device | An active control TENS unit used to reduce acute localized pain. |
|
| 60 days |
| Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities. | 60 days |
| Patient Satisfaction Questionnaire (PSQ) 18 | Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction. | 60 days |
| Binary, Self-reported Opioid Use | Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids). | 60 days |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Active Control | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PROMIS - Physical Function Short Form 8b | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Active Control | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain. |
|
|
|
| Secondary | PROMIS - Pain Interference Short Form 8a | PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average. | Posted | Mean | Standard Deviation | score on a scale | 60 days |
|
|
|
|
| Secondary | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities. | Posted | Mean | Standard Deviation | score on a scale | 60 days |
|
|
|
|
| Secondary | Patient Satisfaction Questionnaire (PSQ) 18 | Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 60 days |
|
|
|
|
| Secondary | Binary, Self-reported Opioid Use | Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids). | Includes all respondents to both primary outcome week 1 and opioid surveys. | Posted | Count of Participants | Participants | 60 days |
|
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Active Control | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain. | 0 | 142 | 0 | 142 | 2 | 142 |
|
| Random discharge & subsequent cramping | Product Issues | Non-systematic Assessment | reported random discharge & subsequent cramping on leg, called me after 2nd occurrence |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| WPAI: Activity Impairment |
|
For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data. |
| t-test, 2 sided |
| .787 |
| Mean Difference (Final Values) |
| 0.0 |
| Standard Error of the Mean |
| .274 |
| 2-Sided |
| 95 |
| -.54 |
| .54 |
| Superiority |
| For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data. | t-test, 2 sided | .569 | Mean Difference (Final Values) | -.20 | Standard Error of the Mean | .34 | 2-Sided | 95 | -.88 | .48 | Superiority |
| PSQ Access |
|