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Completed

NCT Number: NCT03890419

Opioid Sparing Potential of Light-Induced Analgesia

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.

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Key information

Conditions

Pain Acute Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health Systems

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

green light

Device

Green light exposure

Clear light

Device

Full spectrum light exposure

Blue Light

Device

Blue light exposure

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2019
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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