Opioid Sparing Potential of Light-Induced Analgesia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890419
• Other study ID #: Pro00102106
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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