Opioid Sparing Potential of Light-Induced Analgesia

• 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: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: March 21, 2019
• First Posted Date: March 26, 2019
• Results First Submitted Date: August 11, 2021
• Results First Posted Date: October 13, 2021
• Last Update Posted Date: October 13, 2021
• Actual Study Start Date: June 17, 2019
• Actual Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Opioid Sparing Potential of Light-Induced Analgesia
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Pain

Intervention

• Device: Green light
  Green light exposure
• Device: Clear light
  Full spectrum light exposure
• Device: Blue Light
  Blue light exposure

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2021): 94
• Original Estimated Enrollment (submitted: March 25, 2019): 60
• Actual Study Completion Date: March 31, 2021
• Actual Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03890419
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Padma Gulur, MD; Duke University

• PRS Account: Duke University
• Verification Date: September 2021