Opioid Sparing Potential of Light-Induced Analgesia

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03890419
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 3
• Actual Duration (Months): 21.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: Green light; Device: Clear light; Device: Blue Light	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Opioid Sparing Potential of Light-Induced Analgesia: a Pilot Trial of a Novel, Non-Pharmacological Treatment for Pain
• Actual Study Start Date: Jun 17, 2019
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Control Group participants will be exposed to full spectrum light during the study.	Device: Clear light; Full spectrum light exposure
Experimental: Green light Group Green light Group participants will be exposed to green light during the study.	Device: Green light; Green light exposure
Experimental: Blue light Group Blue light Group participants will be exposed to blue light during the study.	Device: Blue Light; Blue light exposure

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health Systems	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Padma Gulur, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 10, 2020
• Informed Consent Form - Nov 10, 2020

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03890419
• Other Study ID Numbers: Pro00102106
• First Posted: Mar 26, 2019
• Last Update Posted: Oct 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: Acute Pain; Chronic Pain; Opioid Use; Pain

Study Results

Participant Flow

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 Participants	34	30	30	94
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (10.2)	59.2 (13.8)	53.9 (12.8)	57.9 (12.5)
Sex: Female, Male (Count of Participants)
Female	22 64.7%	23 76.7%	21 70%	66 70.2%
Male	12 35.3%	7 23.3%	9 30%	28 29.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.9%	0 0%	1 3.3%	3 3.2%
Not Hispanic or Latino	32 94.1%	30 100%	29 96.7%	91 96.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 3.3%	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%	20 66.7%	61 64.9%
More than one race	1 2.9%	4 13.3%	0 0%	5 5.3%
Unknown or Not Reported	0 0%	0 0%	2 6.7%	2 2.1%
Region of Enrollment (Count of Participants)
United States	34 100%	30 100%	30 100%	94 100%

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
Measure Participants	27	25	25
Mean (Standard Deviation) [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
Measure Participants	27	25	25
Mean (Standard Deviation) [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)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/30 (0%)		0/30 (0%)
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%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Green Light Group		Blue Light Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/34 (17.6%)		0/30 (0%)		2/30 (6.7%)
General disorders
Headache/Migraine	6/34 (17.6%)	6	0/30 (0%)	0	2/30 (6.7%)	2

Limitations/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.