We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
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. 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

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 26, 2019
Results First Submitted Date  ICMJE August 11, 2021
Results First Posted Date  ICMJE October 13, 2021
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE June 17, 2019
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Change in Pain Level [ Time Frame: Day 1, Week 1, approximately Week 2 ]
    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, approximately Week 2 ]
    We will measure the amount of opioid medication used for pain relief. This will be measure in oral morphine equivalents.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Sparing Potential of Light-Induced Analgesia
Official Title  ICMJE Opioid Sparing Potential of Light-Induced Analgesia: a Pilot Trial of a Novel, Non-Pharmacological Treatment for Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pain
Intervention  ICMJE
  • Device: Green light
    Green light exposure
  • Device: Clear light
    Full spectrum light exposure
  • Device: Blue Light
    Blue light exposure
Study Arms  ICMJE
  • Active Comparator: Control Group
    Control Group participants will be exposed to full spectrum light during the study.
    Intervention: Device: Clear light
  • Experimental: Green light Group
    Green light Group participants will be exposed to green light during the study.
    Intervention: Device: Green light
  • Experimental: Blue light Group
    Blue light Group participants will be exposed to blue light during the study.
    Intervention: Device: Blue Light
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2021)
94
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
60
Actual Study Completion Date  ICMJE March 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890419
Other Study ID Numbers  ICMJE Pro00102106
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Padma Gulur, MD Duke University
PRS Account Duke University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP