Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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 Other: Green light Other: Clear light Other: Blue Light Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : June 17, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Active Comparator: Control Group
Control Group participants will be exposed to full spectrum light during the study.
Other: Clear light
Full spectrum light exposure

Experimental: Green light Group
Green light Group participants will be exposed to green light during the study.
Other: Green light
Green light exposure

Experimental: Blue light Group
Blue light Group participants will be exposed to green light during the study.
Other: Blue Light
Blue light exposure




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Amanda Nelli, MD 919-681-4988 amanda.nelli@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Health Systems Recruiting
Durham, North Carolina, United States, 27710
Contact: Amanda Nelli, MD    919-861-4988    amanda.nelli@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Padma Gulur, MD Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03890419    
Other Study ID Numbers: Pro00102106
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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