Opioid Sparing Potential of Light-Induced Analgesia

• ClinicalTrials.gov Identifier: NCT03890419
• Recruitment Status: Completed
• First Posted: March 26, 2019
• Results First Posted: October 13, 2021
• Last Update Posted: October 13, 2021
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Pain
• Interventions: Device: Green light; Device: Clear light; Device: Blue Light
• Enrollment: 94

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Control Group	Green Light Group	Blue Light Group
Arm/Group Description	Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure	Green light Group participants will be exposed to green light during the study. Green light: Green light exposure	Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure
Period Title: Overall Study
Started	34	30	30
Completed	27	27	25
Not Completed	7	3	5

Baseline Characteristics

Arm/Group Title		Control Group	Green Light Group	Blue Light Group	Total
Arm/Group Description		Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure	Green light Group participants will be exposed to green light during the study. Green light: Green light exposure	Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure	Total of all reporting groups
Overall Number of Baseline Participants		34	30	30	94
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	30 participants	30 participants	94 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	20 58.8%	19 63.3%	22 73.3%	61 64.9%
	>=65 years	14 41.2%	11 36.7%	8 26.7%	33 35.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	30 participants	30 participants	94 participants
		60.3 (10.2)	59.2 (13.8)	53.9 (12.8)	57.9 (12.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	30 participants	30 participants	94 participants
	Female	22 64.7%	23 76.7%	21 70.0%	66 70.2%
	Male	12 35.3%	7 23.3%	9 30.0%	28 29.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	30 participants	30 participants	94 participants
	Hispanic or Latino	2 5.9%	0 0.0%	1 3.3%	3 3.2%
	Not Hispanic or Latino	32 94.1%	30 100.0%	29 96.7%	91 96.8%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	30 participants	30 participants	94 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 3.3%	0 0.0%	1 1.1%
	Black or African American	10 29.4%	7 23.3%	8 26.7%	25 26.6%
	White	23 67.6%	18 60.0%	20 66.7%	61 64.9%
	More than one race	1 2.9%	4 13.3%	0 0.0%	5 5.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	2 6.7%	2 2.1%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	34 participants	30 participants	30 participants	94 participants
		34 100.0%	30 100.0%	30 100.0%	94 100.0%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Level
Description	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

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Control Group	Green Light Group	Blue Light Group
Arm/Group Description:	Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure	Green light Group participants will be exposed to green light during the study. Green light: Green light exposure	Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure
Overall Number of Participants Analyzed	27	25	25
Mean (Standard Deviation); Unit of Measure: score on a scale
	1.15 (2.84)	-0.04 (1.88)	1.07 (2.33)

2. Primary Outcome

Title	Change in Opioid Dose Used for Pain
Description	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

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Control Group	Green Light Group	Blue Light Group
Arm/Group Description:	Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure	Green light Group participants will be exposed to green light during the study. Green light: Green light exposure	Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure
Overall Number of Participants Analyzed	27	25	25
Mean (Standard Deviation); Unit of Measure: MME
	37.36 (68.23)	37.38 (76.03)	56.20 (151.11)

Adverse Events

Time Frame	Adverse event data was collected from consent through follow-up study visit (2 weeks)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Control Group		Green Light Group		Blue Light Group
Arm/Group Description	Control Group participants will be exposed to full spectrum light during the study. Clear light: Full spectrum light exposure		Green light Group participants will be exposed to green light during the study. Green light: Green light exposure		Blue light Group participants will be exposed to blue light during the study. Blue Light: Blue light exposure
All-Cause Mortality
	Control Group		Green Light Group		Blue Light Group
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/34 (0.00%)		0/30 (0.00%)		0/30 (0.00%)
Serious Adverse Events
	Control Group		Green Light Group		Blue Light Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0.00%)		0/30 (0.00%)		0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	Control Group		Green Light Group		Blue Light Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/34 (17.65%)		0/30 (0.00%)		2/30 (6.67%)
General disorders
Headache/Migraine *	6/34 (17.65%)	6	0/30 (0.00%)	0	2/30 (6.67%)	2
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Padma Gulur
• Organization: Duke University
• Phone: 919-681-4660
• EMail: padma.gulur@duke.edu

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03890419
• Other Study ID Numbers: Pro00102106
• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Results First Submitted: August 11, 2021
• Results First Posted: October 13, 2021
• Last Update Posted: October 13, 2021