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This is a pilot trial testing the potential opioid-sparing analgesic effect of a novel non-pharmacological treatment using visualized light spectrums. Preclinical findings have shown such treatments to alter pain perception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control Group participants will be exposed to full spectrum light during the study. |
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| Green light Group | Experimental | Green light Group participants will be exposed to green light during the study. |
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| Blue light Group | Experimental | Blue light Group participants will be exposed to blue light during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green light | Device | Green light exposure |
| |
| Clear light |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Level | Pain level assessed using the Numeric Rating Scale. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment. | Baseline to end of study |
| Change in Opioid Dose Used for Pain | Change in amount of opioid medication used for pain relief measured in oral morphine equivalents. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment. | Baseline to end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Padma Gulur, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health Systems | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure |
| FG001 | Green Light Group | Green light Group participants will be exposed to green light during the study. Green light: Green light exposure |
| FG002 | Blue Light Group | Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure |
| BG001 | Green Light Group | Green light Group participants will be exposed to green light during the study. Green light: Green light exposure |
| 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 | Change in Pain Level | Pain level assessed using the Numeric Rating Scale. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment. | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of study |
|
Adverse event data was collected from consent through follow-up study visit (2 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 | Control Group | Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache/Migraine | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Padma Gulur | Duke University | 919-681-4660 | padma.gulur@duke.edu |
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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 | Nov 10, 2020 | Jul 29, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2020 | Feb 17, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
Full spectrum light exposure |
|
| Blue Light | Device | Blue light exposure |
|
| BG002 | Blue Light Group | Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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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| Region of Enrollment | Count of Participants | Participants |
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| OG001 |
| Green Light Group |
Green light Group participants will be exposed to green light during the study. Green light: Green light exposure |
| OG002 | Blue Light Group | Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure |
|
|
| Primary | Change in Opioid Dose Used for Pain | Change in amount of opioid medication used for pain relief measured in oral morphine equivalents. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment. | Participants with available data. | Posted | Mean | Standard Deviation | MME | Baseline to end of study |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 6 |
| 34 |
| EG001 | Green Light Group | Green light Group participants will be exposed to green light during the study. Green light: Green light exposure | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Blue Light Group | Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure | 0 | 30 | 0 | 30 | 2 | 30 |
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