Opioid Sparing Potential of Light-Induced Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Opioid Sparing Potential of Light-Induced Analgesia: a Pilot Trial of a Novel, Non-Pharmacological Treatment for Pain

Conditions
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Pain

Intervention / Treatment
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* Device: Green light
* Device: Clear light
* Device: Blue Light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Control Group participants will be exposed to full spectrum light during the study. | Device: Clear light<br>* Full spectrum light exposure<br>|
| Experimental: Green light Group<br>Green light Group participants will be exposed to green light during the study. | Device: Green light<br>* Green light exposure<br>|
| Experimental: Blue light Group<br>Blue light Group participants will be exposed to blue light during the study. | Device: Blue Light<br>* Blue light exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Level | 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. | Baseline to end of study | 
| Change in Opioid Dose Used for Pain | 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. | Baseline to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain, Chronic Pain, Opioid Use, Pain