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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 Description
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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

Study Design
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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 : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 blue light during the study.
 Device: Blue Light
Blue light exposure


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
Contacts and Locations
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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:
Study Protocol and Statistical Analysis Plan  [PDF] November 10, 2020
Informed Consent Form  [PDF] November 10, 2020

More Information
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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
Results First Posted: October 13, 2021
Last Update Posted: October 13, 2021
Last Verified: September 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