Trial Outcomes & Findings for Opioid Sparing Potential of Light-Induced Analgesia (NCT NCT03890419)
NCT ID: NCT03890419
Last Updated: 2021-10-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
Baseline to end of study
Results posted on
2021-10-13
Participant Flow
Participant milestones
| Measure |
Control Group
Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure
|
Green Light Group
Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure
|
Blue Light Group
Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid Sparing Potential of Light-Induced Analgesia
Baseline characteristics by cohort
| Measure |
Control Group
n=34 Participants
Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure
|
Green Light Group
n=30 Participants
Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure
|
Blue Light Group
n=30 Participants
Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
59.2 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
53.9 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
57.9 years
STANDARD_DEVIATION 12.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
91 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
94 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of studyPopulation: Participants with available data.
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.
Outcome measures
| Measure |
Control Group
n=27 Participants
Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure
|
Green Light Group
n=25 Participants
Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure
|
Blue Light Group
n=25 Participants
Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure
|
|---|---|---|---|
|
Change in Pain Level
|
1.15 score on a scale
Standard Deviation 2.84
|
-0.04 score on a scale
Standard Deviation 1.88
|
1.07 score on a scale
Standard Deviation 2.33
|
PRIMARY outcome
Timeframe: Baseline to end of studyPopulation: Participants with available data.
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.
Outcome measures
| Measure |
Control Group
n=27 Participants
Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure
|
Green Light Group
n=25 Participants
Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure
|
Blue Light Group
n=25 Participants
Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure
|
|---|---|---|---|
|
Change in Opioid Dose Used for Pain
|
37.36 MME
Standard Deviation 68.23
|
37.38 MME
Standard Deviation 76.03
|
56.20 MME
Standard Deviation 151.11
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Green Light Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blue Light Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=34 participants at risk
Control Group participants will be exposed to full spectrum light during the study.
Clear light: Full spectrum light exposure
|
Green Light Group
n=30 participants at risk
Green light Group participants will be exposed to green light during the study.
Green light: Green light exposure
|
Blue Light Group
n=30 participants at risk
Blue light Group participants will be exposed to blue light during the study.
Blue Light: Blue light exposure
|
|---|---|---|---|
|
General disorders
Headache/Migraine
|
17.6%
6/34 • Number of events 6 • Adverse event data was collected from consent through follow-up study visit (2 weeks)
|
0.00%
0/30 • Adverse event data was collected from consent through follow-up study visit (2 weeks)
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected from consent through follow-up study visit (2 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place