Opioid Sparing Potential of Light-Induced Analgesia
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|ClinicalTrials.gov Identifier: NCT03890419|
Recruitment Status : Completed
First Posted : March 26, 2019
Results First Posted : October 13, 2021
Last Update Posted : October 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Green light Device: Clear light Device: Blue Light||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|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 :||June 17, 2019|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
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
- Change in Pain Level [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890419
|United States, North Carolina|
|Duke University Health Systems|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Padma Gulur, MD||Duke University|