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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03890419|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Green light Device: Clear light Device: Blue Light||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 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|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
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 green light during the study.
Device: Blue Light
Blue light exposure
- Change in Pain Level [ Time Frame: Day 1, Week 1 and approximately Week 2 (chronic pain) or 48 hours (acute pain) ]We will assess the patients pain level 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.
- Change in Opioid dose used for pain [ Time Frame: Day 1, Week 1 and approximately Week 2 (chronic pain) or 48 hours (acute pain) ]We will measure the amount of opioid medication used for pain relief. This will be measure in oral morphine equivalents.
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
|Contact: Amanda Nelli, MDemail@example.com|
|United States, North Carolina|
|Duke University Health Systems||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Amanda Nelli, MD 919-861-4988 firstname.lastname@example.org|
|Principal Investigator:||Padma Gulur, MD||Duke University|