Pain
Conditions
Keywords
Acute Pain, Chronic Pain, Opioid Use, Pain
Brief summary
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.
Interventions
DEVICEGreen light
Green light exposure
DEVICEClear light
Full spectrum light exposure
DEVICEBlue Light
Blue light exposure
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for thoracic surgery for which post-operative opioid PCA is anticipated (Acute Pain group) OR currently treated with opioid therapy for fibromyalgia (Chronic Pain group) * 18 years of age and older * Able to wear study eyeglasses for at least 4 hours per day * Agree to participate and provide written informed consent and HIPAA authorization
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Level | Baseline to end of study | 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. |
| Change in Opioid Dose Used for Pain | Baseline to end of study | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure | 34 |
| Green Light Group Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure | 30 |
| Blue Light Group Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure | 30 |
| Total | 94 |
Baseline characteristics
| Characteristic | Control Group | Green Light Group | Blue Light Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 11 Participants | 8 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 22 Participants | 61 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 10.2 | 59.2 years STANDARD_DEVIATION 13.8 | 53.9 years STANDARD_DEVIATION 12.8 | 57.9 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 29 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 7 Participants | 8 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 18 Participants | 20 Participants | 61 Participants |
| Region of Enrollment United States | 34 Participants | 30 Participants | 30 Participants | 94 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 21 Participants | 66 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 6 / 34 | 0 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Baseline to end of study
Population: Participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Opioid Dose Used for Pain | 37.36 MME | Standard Deviation 68.23 |
| Green Light Group | Change in Opioid Dose Used for Pain | 37.38 MME | Standard Deviation 76.03 |
| Blue Light Group | Change in Opioid Dose Used for Pain | 56.20 MME | Standard Deviation 151.11 |
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.
Time frame: Baseline to end of study
Population: Participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Pain Level | 1.15 score on a scale | Standard Deviation 2.84 |
| Green Light Group | Change in Pain Level | -0.04 score on a scale | Standard Deviation 1.88 |
| Blue Light Group | Change in Pain Level | 1.07 score on a scale | Standard Deviation 2.33 |