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Opioid Sparing Potential of Light-Induced Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Green Light Group Blue Light Group
Hide 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
Arm/Group Title Control Group Green Light Group Blue Light Group Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in Pain Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Control Group Green Light Group Blue Light Group
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Control Group Green Light Group Blue Light Group
Hide 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)
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
Hide 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%)    
Hide 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%)    
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Padma Gulur
Organization: Duke University
Phone: 919-681-4660
EMail: padma.gulur@duke.edu
Layout table for additonal information
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