Opioid Sparing Potential of Light-Induced Analgesia

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Clear light; Device: Blue Light; Device: Green light

• Registration Number: NCT03890419
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-06-17
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2021-08-11
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Results First Posted: 2021-10-13
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Clear light	Control Group participants will be exposed to full spectrum light during the study.
Blue light Group	Blue Light	Blue light Group participants will be exposed to blue light during the study.
Green light Group	Green light	Green light Group participants will be exposed to green light during the study.

Primary Outcome Measures

Name	Time	Method
Change in Pain Level	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	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.

Trial Locations

Locations (1)

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States