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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
Last Update Posted : February 21, 2021
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 Device: Green light Device: Clear light Device: Blue Light Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : June 17, 2019
Actual Primary Completion Date : December 24, 2020
Actual Study Completion Date : December 24, 2020

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 green light during the study.
Device: 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

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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


Locations
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United States, North Carolina
Duke University Health Systems
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Padma Gulur, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] November 10, 2020

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03890419    
Other Study ID Numbers: Pro00102106
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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